Download PDF

Clinical Trial Results:
An Open-Label Extension Study to Assess The Long-Term Safety And Clinical Benefit of Etanercept in Children And Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis Who Were Previously Enrolled in Protocol 0881A1-3338-WW (B1801014)

Summary
EudraCT number	2010-023802-10
Trial protocol	HU BE FR LT SK CZ SI ES DE LV PL NL Outside EU/EEA NO IT
Global end of trial date	04 Feb 2021

Results information
Results version number	v1(current)
This version publication date	15 Aug 2021
First version publication date	15 Aug 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

B1801023

ISRCTN number

US NCT number

NCT01421069

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001236-PIP20-10

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

02 Mar 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 Feb 2021

Global end of trial reached?

Yes

Global end of trial date

04 Feb 2021

Was the trial ended prematurely?

Main objective of the trial

To monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular Juvenile idiopathic arthritis (JIA), enthesitis related arthritis (ERA), or psoriatic arthritis (PsA).

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Oct 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 4

Country: Number of subjects enrolled

Belgium: 10

Country: Number of subjects enrolled

Colombia: 3

Country: Number of subjects enrolled

Czechia: 5

Country: Number of subjects enrolled

Germany: 16

Country: Number of subjects enrolled

Spain: 3

Country: Number of subjects enrolled

France: 7

Country: Number of subjects enrolled

Hungary: 10

Country: Number of subjects enrolled

Italy: 3

Country: Number of subjects enrolled

Lithuania: 7

Country: Number of subjects enrolled

Latvia: 9

Country: Number of subjects enrolled

Mexico: 2

Country: Number of subjects enrolled

Netherlands: 3

Country: Number of subjects enrolled

Norway: 1

Country: Number of subjects enrolled

Poland: 15

Country: Number of subjects enrolled

Russian Federation: 11

Country: Number of subjects enrolled

Serbia: 14

Country: Number of subjects enrolled

Slovakia: 2

Country: Number of subjects enrolled

Slovenia: 2

Worldwide total number of subjects

127

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

This was an extension study in pediatric subjects diagnosed with one of three subtypes of juvenile idiopathic arthritis (JIA): extended oligoarticular JIA, enthesitis related arthritis (ERA), or psoriatic arthritis (PsA) had received at least one dose of Etanercept and completed approximately 96 weeks of participation in study 0881A1-3338.

Screening details

This study has 3 periods: Active treatment period, Withdrawal/Re-treatment period and Observational period.

Period 1 title

Parent Study

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Etanercept

Arm description

Subjects aged <18 years & weighed <=62 kg received Etanercept(Etn)SC dose of 0.8 mg/kg once a week, for active treatment period (ACT) for maximum of 96 months. Subjects who either met Wallace definition for clinically inactive disease for at least 6 months on Etn or who had a good clinical response & would benefit from withdrawal from Etn & were otherwise eligible entered withdrawal period. Subjects requiring re-treatment per investigator’s clinical judgment and otherwise eligible entered re-treatment period. Subjects who discontinued Etn prior to completing 96 weeks of active treatment in study 0881A1-3338 for any reason or not eligible to continue Etn in study B1801023 asked to enter observational period directly. Subjects from ACT,withdrawal/re-treatment period who discontinued Etn prior to completion of study, asked to participate in observational period. In observational period, all subjects followed up for a maximum of 96 months from the time of initial entry into this study.

Arm type

Experimental

Investigational medicinal product name

Etanercept

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly SC for 96 months.

Number of subjects in period 1	Etanercept
Started	127
Completed	127

Period 2 title

Overall study(Extension Study-96 months)

Is this the baseline period?

Yes ^[1]

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Etanercept

Arm description

Arm type

Experimental

Investigational medicinal product name

Etanercept

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly SC for 96 months.

Notes
[1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: Period 1 has the data from the parent study. However, Overall study represents the participant flow for the extension study. Therefore, Overall study (Extension Study-96 months) has been selected as the baseline period.

Number of subjects in period 2 ^[2] ^[3]	Etanercept
Started	109
Entered Active Treatment Period	99
Completed	27
Not completed	82
Withdrawn Due To Pregnancy	1
Enrolled in Observational Period	29
No Longer Willing To Participate In Study	8
Adverse event	1
Enrolled in Withdrawal Period	30
Insufficient Clinical Response	1
Unspecified	1
Medication Error Without Associated Adverse Event	1
Subjects entered in observational period	10

Notes
[2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The worldwide number represents the subjects enrolled in the parent study. The results reported here are for extension study. Therefore, Overall study (Extension Study-96 months) has been selected as the baseline period and its is not same as worldwide number enrolled in the trial
[3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: The Parent Study period, has the data of subjects form the parent study B1801014. The subjects in the extension study entered from the parent study, mentioned here as Overall study (Extension Study-96 months). So the number of subjects are not same.

Period 3 title

Withdrawal(Wit)/Retreatment:Witphase

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Etanercept

Arm description

Subjects aged <18 years & weighed <=62 kg received Etanercept (Etn) SC dose of 0.8 mg/kg once a week, for ACT for maximum of 96 months. Subjects who either met Wallace definition for clinically inactive disease for at least 6 months on Etn or who had a good clinical response & would benefit from withdrawal from Etn & were otherwise eligible entered withdrawal period. Subjects requiring re-treatment per investigator’s clinical judgment and otherwise eligible entered re-treatment period. Subjects who discontinued Etn prior to completing 96 weeks of active treatment in study 0881A1-3338 for any reason or not eligible to continue Etn in study B1801023 asked to enter observational period directly. Subjects from ACT,withdrawal/re-treatment period who discontinued Etn prior to completion of study, asked to participate in observational period. In observational period, all subjects followed up for a maximum of 96 months from the time of initial entry into this study.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 3 ^[4]	Etanercept
Started	27
Completed	7
Not completed	23
Enrolled in Observational Period	7
No Longer Willing To Participate In Study	2
Enrolled in Re-Treatment Period	13
Lost to follow-up	1
Joined	3
Transferred in from other group/arm	3

Notes
[4] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
Justification: The net number of transfers in and out of the arms in a period, is not zero as few subjects entered the withdrawal period directly from the parent study and were further transferred in observational period or re-treatment period.

Period 4 title

Wit/Retreatment:Reteatmentphase

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Etanercept

Arm description

Subjects aged <18 years & weighed <=62 kg received Etanercept (Etn) SC dose of 0.8 mg/kg once a week, for ACT for maximum of 96 months. Subjects who either met Wallace definition for clinically inactive disease for at least 6 months on Etn or who had a good clinical response & would benefit from withdrawal from Etn & were otherwise eligible entered withdrawal period. Subjects requiring re-treatment per investigator’s clinical judgment and otherwise eligible entered re-treatment period. Subjects who discontinued Etn prior to completing 96 weeks of active treatment in study 0881A1-3338 for any reason or not eligible to continue Etn in study B1801023 asked to enter observational period directly. Subjects from ACT, withdrawal/re-treatment period who discontinued Etn prior to completion of study, asked to participate in observational period. In observational period, all subjects followed up for a maximum of 96 months from the time of initial entry into this study.

Arm type

Experimental

Investigational medicinal product name

Etanercept

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly SC for 96 months.

Number of subjects in period 4 ^[5]	Etanercept
Started	7
Completed	5
Not completed	8
Enrolled in Observational Period	7
Protocol deviation	1
Joined	6
Transferred in from other group/arm	6

Notes
[5] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
Justification: The net number of transfers in and out of the arms in a period, is not zero as few subjects entered the withdrawal period directly from the parent study and were further transferred in observational period or re-treatment period.

Period 5 title

Observational Period (96 months)

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Etanercept

Arm description

Subjects aged <18 years & weighed <=62 kg received Etanercept (Etn) SC dose of 0.8 mg/kg once a week, for ACT for maximum of 96 months. Subjects who either met Wallace definition for clinically inactive disease for at least 6 months on Etn or who had a good clinical response & would benefit from withdrawal from Etn & were otherwise eligible entered withdrawal period. Subjects requiring re-treatment per investigator’s clinical judgment and otherwise eligible entered re-treatment period. Subjects who discontinued Etn prior to completing 96 weeks of active treatment in study 0881A1-3338 for any reason or not eligible to continue Etn in study B1801023 asked to enter observational period directly. Subjects from ACT, withdrawal/re-treatment period who discontinued Etn prior to completion of study, asked to participate in observational period. In observational period, all subjects followed up for a maximum of 96 months from the time of initial entry into this study.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 5 ^[6]	Etanercept
Started	5
Completed	45
Not completed	8
No Longer Willing To Participate In Study	4
Unspecified	1
Lost to follow-up	3
Joined	48
Transferred in from other group/arm	48

Notes
[6] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
Justification: The net number of transfers in and out of the arms in a period, is not zero as few subjects entered the withdrawal period directly from the parent study and were further transferred in observational period or re-treatment period.

Baseline characteristics

Top of page

Reporting group title

Etanercept

Reporting group description

Reporting group values	Etanercept	Total
Number of subjects	109	109
Age Categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	32	32
Adolescents (12-17 years)	58	58
Adults (18-64 years)	19	19
From 65-84 years	0	0
85 years and over	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	13.28 ( 4.49 )	-
Gender Categorical
Units: Subjects
Female	61	61
Male	48	48
Race (NIH/OMB)
Units: Subjects
White	101	101
Asian	1	1
Other	7	7

End points

Top of page

Reporting group title

Etanercept

Reporting group description

Reporting group title

Etanercept

Reporting group description

Reporting group title

Etanercept

Reporting group description

Reporting group title

Etanercept

Reporting group description

Subjects aged <18 years & weighed <=62 kg received Etanercept (Etn) SC dose of 0.8 mg/kg once a week, for ACT for maximum of 96 months. Subjects who either met Wallace definition for clinically inactive disease for at least 6 months on Etn or who had a good clinical response & would benefit from withdrawal from Etn & were otherwise eligible entered withdrawal period. Subjects requiring re-treatment per investigator’s clinical judgment and otherwise eligible entered re-treatment period. Subjects who discontinued Etn prior to completing 96 weeks of active treatment in study 0881A1-3338 for any reason or not eligible to continue Etn in study B1801023 asked to enter observational period directly. Subjects from ACT, withdrawal/re-treatment period who discontinued Etn prior to completion of study, asked to participate in observational period. In observational period, all subjects followed up for a maximum of 96 months from the time of initial entry into this study.

Reporting group title

Etanercept

Reporting group description

Subjects aged <18 years & weighed <=62 kg received Etanercept (Etn) SC dose of 0.8 mg/kg once a week, for ACT for maximum of 96 months. Subjects who either met Wallace definition for clinically inactive disease for at least 6 months on Etn or who had a good clinical response & would benefit from withdrawal from Etn & were otherwise eligible entered withdrawal period. Subjects requiring re-treatment per investigator’s clinical judgment and otherwise eligible entered re-treatment period. Subjects who discontinued Etn prior to completing 96 weeks of active treatment in study 0881A1-3338 for any reason or not eligible to continue Etn in study B1801023 asked to enter observational period directly. Subjects from ACT, withdrawal/re-treatment period who discontinued Etn prior to completion of study, asked to participate in observational period. In observational period, all subjects followed up for a maximum of 96 months from the time of initial entry into this study.

Subject analysis set title

Etanercept: Active Treatment Period

Subject analysis set type

Full analysis

Subject analysis set description

Subjects aged <18 years and weighed less than or equal to 62 kg received Etanercept as a SC dose of 0.8 mg/kg once a week (for up to a maximum dose of 50 mg once weekly), for an active treatment period for a maximum of 96 months.

Subject analysis set title

Etanercept: Withdrawal Period

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects who either completed 96 weeks of treatment in study 0881A-3338 or were enrolled in the active treatment period of study B1801023 and who had either met the Wallace definition for clinically inactive disease for at least 6 months on Etanercept or who had a good clinical response and would benefit from withdrawal from Etanercept and were otherwise eligible entered the withdrawal period.

Subject analysis set title

Etanercept: Re-treatment Period

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects requiring re-treatment per the investigator’s clinical judgment and were otherwise eligible entered the Re-treatment period.

Subject analysis set title

Etanercept: Observational Period

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subjects who discontinued Etanercept prior to completing 96 weeks of active treatment in study 0881A1-3338 for any reason or not eligible to continue Etanercept in study B1801023 asked to enter the observational period directly. Subjects from active treatment, withdrawal or re-treatment period who discontinued Etanercept prior to the completion of the study, asked to participate in the observational period. In observational period, all subjects followed up for a maximum of 96 months from the time of initial entry into this study.

Subject analysis set title

Enthesitis-Related Arthritis

Subject analysis set type

Full analysis

Subject analysis set description

To be diagnosed with enthesitis-related arthritis (ERA) per the International League Associations for Rheumatology (ILAR) criteria, a subject must have had arthritis and enthesitis, or arthritis or enthesitis plus 2 of the following: 1) presence of or a history of sacroiliac joint tenderness and/or inflammatory lumbosacral pain; 2) the presence of human leukocyte antigen, subtype B, number 27 antigen (HLA-B27); 3) onset of arthritis in a male over 6 years of age; 4) acute (symptomatic) anterior uveitis; 5) a history of ankylosing spondylitis, ERA, sacroiliitis with inflammatory bowel disease, Reiter’s syndrome, or acute anterior uveitis in a first-degree relative.

Subject analysis set title

Psoriatic Arthritis (PsA)

Subject analysis set type

Full analysis

Subject analysis set description

To be diagnosed with psoriatic arthritis (PsA) per the International League Associations for Rheumatology (ILAR) criteria, a subject must have had arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative.

Subject analysis set title

All Periods (Parent and Extension Study)

Subject analysis set type

Full analysis

Subject analysis set description

Full analysis set (FAS) includes all subjects in the parent study (0881A1-3338-WW) who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

Subject analysis set title

Etanercept: Withdrawal/Re-treatment Period

Subject analysis set type

Sub-group analysis

Subject analysis set description

Primary: Number of Subjects With Malignancy: All Periods: Parent and Extension Study

Top of page

End point title

Number of Subjects With Malignancy: All Periods: Parent and Extension Study ^[1]

End point description

Malignancy event included Hodgkin's disease. FAS includes all subjects in the parent study (0881A1-3338-WW) who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

End point type

Primary

End point timeframe

Baseline up to Month 96

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive analysis was done for this endpoint

End point values	All Periods (Parent and Extension Study)
Number of subjects analysed	127
Units: Subjects	1

No statistical analyses for this end point

Secondary: Number of Subjects With Serious Adverse Events: All Periods: Parent and Extension Study

Top of page

End point title

Number of Subjects With Serious Adverse Events: All Periods: Parent and Extension Study

End point description

A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. FAS includes all subjects in the parent study (0881A1-3338-WW) who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	All Periods (Parent and Extension Study)
Number of subjects analysed	127
Units: Subjects	45

No statistical analyses for this end point

Secondary: Number of Subjects With Serious Infections: All Periods: Parent and Extension Study

Top of page

End point title

Number of Subjects With Serious Infections: All Periods: Parent and Extension Study

End point description

Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization. The full analysis set included all subjects in the parent study (0881A1-3338-WW) who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	All Periods (Parent and Extension Study)
Number of subjects analysed	127
Units: Subjects	14

No statistical analyses for this end point

Secondary: Number of Subjects With Medically Important Infections: All Periods: Parent and Extension Study

Top of page

End point title

Number of Subjects With Medically Important Infections: All Periods: Parent and Extension Study

End point description

Medically important infections were defined as an infection requiring parenteral [intravenous (IV), intramuscular (IM)] anti-infective agent(s) and/or hospitalization. The full analysis set included all subjects in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

End point type

Secondary

End point timeframe

Baseline upto Month 96

End point values	All Periods (Parent and Extension Study)
Number of subjects analysed	127
Units: Subjects	12

No statistical analyses for this end point

Secondary: Number of Subjects With Infections: All Periods: Parent and Extension Study

Top of page

End point title

Number of Subjects With Infections: All Periods: Parent and Extension Study

End point description

The full analysis set included all subjects in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

End point type

Secondary

End point timeframe

Baseline upto Month 96

End point values	All Periods (Parent and Extension Study)
Number of subjects analysed	127
Units: Subjects	111

No statistical analyses for this end point

Secondary: Number of Subjects With Infections and Injection Site Reactions: All Periods: Extension Study

Top of page

End point title

Number of Subjects With Infections and Injection Site Reactions: All Periods: Extension Study

End point description

Adverse events (AE) are any untoward medical occurrence in a subject who received study medication without regard to possibility of causal relationship to it. Adverse events included infections, infections considered preventable by vaccination and injection site reactions. The analysis set included all subjects enrolled in the extension study.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	Etanercept
Number of subjects analysed	109
Units: Subjects
Treatment emergent infections	67
Injection site reactions	16

No statistical analyses for this end point

Secondary: Number of Subjects With Infections: Withdrawal Period: Extension Study

Top of page

End point title

Number of Subjects With Infections: Withdrawal Period: Extension Study

End point description

Adverse event (AE) are any untoward medical occurrence in a subject who received study medication without regard to possibility of causal relationship to it. Adverse events included infections, infections considered preventable by vaccination and injection site reactions. Analysis population included subjects enrolled in parent study and entered in withdrawal/re-treatment period.

End point type

Secondary

End point timeframe

Withdrawal from study treatment to end of study (From Day 1 up to Month 96)

End point values	Etanercept: Withdrawal Period
Number of subjects analysed	30
Units: Subjects
Treatment emergent infections	8
Infections considered preventable by vaccination	1

No statistical analyses for this end point

Secondary: Number of Subjects Withdrawn Due to Adverse Events: All Periods: Parent and Extension Study

Top of page

End point title

Number of Subjects Withdrawn Due to Adverse Events: All Periods: Parent and Extension Study

End point description

In this endpoint, subjects withdrawn due adverse events were reported. The analysis set included all subjects enrolled in the extension study.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	All Periods (Parent and Extension Study)
Number of subjects analysed	127
Units: Subjects
Due to infections	3
Due to other adverse events	14
Due to injection site reactions	0

No statistical analyses for this end point

Secondary: Number of Subjects Withdrawn Due to Adverse Events: Withdrawal Period: Extension Study

Top of page

End point title

Number of Subjects Withdrawn Due to Adverse Events: Withdrawal Period: Extension Study

End point description

Subjects withdrawn due to adverse events were reported. Analysis population included subjects enrolled in parent study and entered in withdrawal/re-treatment period.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	Etanercept: Withdrawal Period
Number of subjects analysed	30
Units: Subjects	0

No statistical analyses for this end point

Secondary: Number of Subjects With Grade 3 or Grade 4 Laboratory Abnormalities: All Periods: Extension Study

Top of page

End point title

Number of Subjects With Grade 3 or Grade 4 Laboratory Abnormalities: All Periods: Extension Study

End point description

Clinically notable shifts were defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. FAS includes all subjects in the parent study (0881A1-3338-WW) who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, “n” signifies subjects evaluable for specific parameter.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	Etanercept
Number of subjects analysed	109
Units: Subjects
Grade 3	2
Grade 4	0

No statistical analyses for this end point

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 48, 60, 72, 84, 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Z-Score at Month 12, 24, 36, 48, 60, 72, 84, 96: All Periods: Extension Study

End point description

Growth parameters included weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. The analysis set included all subjects enrolled in extension study.

End point type

Secondary

End point timeframe

Baseline, Month 12, 24, 36, 48, 60, 72, 84, 96

End point values	Etanercept
Number of subjects analysed	97
Units: z-score
arithmetic mean (standard deviation)
At Baseline; Height (n=97)	0.22 ( 0.43 )
At Month 12; Height (n=88)	0.22 ( 0.46 )
At Month 24; Height (n=55)	0.17 ( 0.56 )
At Month 36; Height (n=43)	0.21 ( 0.66 )
At Month 48; Height (n=28)	0.19 ( 0.58 )
At Month 60; Height (n=13)	0.25 ( 0.67 )
At Month 72; Height (n=10)	0.30 ( 0.90 )
At Month 84; Height (n=5)	0.09 ( 0.53 )
At Month 96; Height (n=4)	0.16 ( 0.63 )
At Baseline; Weight (n=99)	0.09 ( 0.57 )
At Month 12; Weight (n=81)	0.05 ( 0.60 )
At Month 24; Weight (n=53)	-0.04 ( 0.68 )
At Month 36; Weight (n=40)	-0.06 ( 0.72 )
At Month 48; Weight (n=25)	-0.00 ( 0.71 )
At Month 60; Weight (n=13)	0.25 ( 0.64 )
At Month 72; Weight (n=10)	0.45 ( 0.74 )
At Month 84; Weight (n=5)	0.04 ( 0.62 )
At Month 96; Weight (n=4)	0.27 ( 0.68 )
At Baseline; BMI (n=97)	-0.02 ( 0.80 )
At Month 12; BMI (n=88)	-0.03 ( 0.77 )
At Month 24; BMI (n=55)	-0.13 ( 0.86 )
At Month 36; BMI (n=43)	-0.19 ( 0.79 )
At Month 48; BMI (n=28)	-0.17 ( 0.87 )
At Month 60; BMI (n=13)	0.02 ( 0.86 )
At Month 72; BMI (n=10)	0.26 ( 1.00 )
At Month 84; BMI (n=5)	0.00 ( 0.99 )
At Month 96; BMI (n=4)	0.27 ( 1.21 )

No statistical analyses for this end point

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72: Withdrawal Period: Extension Study

End point description

Growth parameters included weight, height and BMI were compared to the standard growth data by using Z-Score. Z-score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. 99999 signifies that standard deviation was not estimable as only 1 subject was evaluated. Data for this endpoint was estimable till week 72 only.

End point type

Secondary

End point timeframe

Baseline, Month 12, 24, 36, 42, 48, 60, 72

End point values	Etanercept
Number of subjects analysed	18
Units: z-score
arithmetic mean (standard deviation)
At Month 12; Height (n=9)	-0.10 ( 0.21 )
At Month 24; Height (n=5)	-0.13 ( 0.28 )
At Month 36; Height (n=3)	0.03 ( 0.05 )
At Month 48; Height (n=1)	0.26 ( 99999 )
At Month 60; Height (n=1)	0.41 ( 99999 )
At Month 72; Height (n=1)	0.52 ( 99999 )
At Month 12; Weight (n=9)	-0.07 ( 0.25 )
At Month 24; Weight (n=4)	-0.09 ( 0.35 )
At Month 36; Weight (n=3)	-0.05 ( 0.42 )
At Month 48; Weight (n=1)	0.22 ( 99999 )
At Month 60; Weight (n=1)	0.46 ( 99999 )
At Month 72; Weight (n=1)	0.60 ( 99999 )
At Month 12; BMI (n=9)	-0.04 ( 0.24 )
At Month 24; BMI (n=5)	-0.14 ( 0.30 )
At Month 36; BMI (n=3)	0.06 ( 0.51 )
At Month 48; BMI (n=1)	0.51 ( 99999 )
At Month 60; BMI (n=1)	0.72 ( 99999 )
At Month 72; BMI (n=1)	0.72 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60: Re-treatment Period: Extension Study

End point description

Growth parameters included weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, >0 a greater mean, and <0 a lesser mean than the standard. In this study, infant growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Data for this endpoint was estimable till Week 60 only.

End point type

Secondary

End point timeframe

Baseline, Month 12, 24, 36, 42, 48, 60

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	9
Units: z-score
arithmetic mean (standard deviation)
At Month 12; Height (n=9)	-0.21 ( 0.31 )
At Month 24; Height (n=8)	-0.19 ( 0.43 )
At Month 36; Height (n=6)	-0.19 ( 0.41 )
At Month 48; Height (n=4)	0.07 ( 0.12 )
At Month 60; Height (n=2)	-0.08 ( 0.27 )
At Month 96; Height (n=0)	99999 ( 99999 )
At Month 12; Weight (n=9)	0.08 ( 0.26 )
At Month 24; Weight (n=8)	-0.07 ( 0.32 )
At Month 36; Weight (n=7)	-0.15 ( 0.43 )
At Month 48; Weight (n=4)	-0.33 ( 0.58 )
At Month 60; Weight (n=2)	-0.57 ( 0.12 )
At Month 72; Weight (n=1)	-1.06 ( 99999 )
At Month 96; Weight (n=0)	99999 ( 99999 )
At Month 12; BMI (n=9)	0.27 ( 0.60 )
At Month 24; BMI (n=8)	0.01 ( 0.71 )
At Month 36; BMI (n=6)	-0.17 ( 0.83 )
At Month 48; BMI (n=4)	-0.59 ( 0.90 )
At Month 60; BMI (n=2)	-0.85 ( 0.16 )
At Month 96; BMI (n=0)	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Change from Baseline in Tanner Assessment Score for Subjects Aged <18 Years at Month 96: All Periods: Extension Study

Top of page

End point title

Change from Baseline in Tanner Assessment Score for Subjects Aged <18 Years at Month 96: All Periods: Extension Study

End point description

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). The analysis set included all subjects enrolled in the extension study.

End point type

Secondary

End point timeframe

Baseline, Month 96

End point values	Etanercept
Number of subjects analysed	1
Units: Units on a scale
arithmetic mean (standard deviation)	4 ( 99999 )

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

End point description

ACR 30 pediatric response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. PGAwasmeasuredonVAS rangingfrom0to10,higherscoresindicatedgreaterdiseaseactivity. Patient/ParentGlobalAssessmentassessed by subject's parentusingVAS ranging from 0to10, 0=very well and 10=very poor. CHAQscore:0=no difficultyto3=extremedifficulty. Jointswithactivearthritisdefinedasjointsthatwereswollenoraccompanied by pain and/or tenderness. Decrease in CRP indicated reduction in inflammation and therefore improvement. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	61
Units: Percentage of subjects
number (confidence interval 95%)
Month 6 (n=23)	95.7 (78.1 to 99.9)
Month 12 (n=61)	98.4 (91.2 to 100)
Month 18 (n=61)	96.7 (88.7 to 99.6)
Month 24 (n=55)	100 (93.5 to 100)
Month 30 (n=53)	100 (93.3 to 100)
Month 36 (n=48)	100 (92.6 to 100)
Month 42 (n=46)	95.7 (85.2 to 99.5)
Month 48 (n=43)	97.7 (87.7 to 99.9)
Month 54 (n=38)	100 (90.7 to 100)
Month 60 (n=34)	100 (89.7 to 100)
Month 66 (n=31)	100 (88.8 to 100)
Month 72 (n=25)	100 (86.3 to 100)
Month 78 (n=24)	100 (85.8 to 100)
Month 84 (n=21)	100 (83.9 to 100)
Month 90 (n=22)	100 (84.6 to 100)
Month 96 (n=16)	100 (79.4 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

End point description

ACR 30 pediatric response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. t. The analysis set included all subjects enrolled in the extension study. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points. Data for this end point was estimable till Week72 only.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

End point values	Etanercept
Number of subjects analysed	23
Units: Percentage of subjects
number (confidence interval 95%)
Month 1 (n=23)	95.7 (78.1 to 99.9)
Month 3 (n=15)	100 (78.2 to 100)
Month 6 (n=11)	100 (71.5 to 100)
Month 9 (n=9)	88.9 (51.8 to 99.7)
Month 12 (n=9)	88.9 (51.8 to 99.7)
Month 18 (n=8)	100 (63.1 to 100)
Month 24 (n=5)	100 (47.8 to 100)
Month 30 (n=4)	100 (39.8 to 100)
Month 36 (n=4)	100 (39.8 to 100)
Month 42 (n=4)	100 (39.8 to 100)
Month 48 (n=3)	66.7 (9.4 to 99.2)
Month 54 (n=1)	100 (2.5 to 100)
Month 60 (n=2)	100 (15.8 to 100)
Month 66 (n=1)	100 (2.5 to 100)
Month 72 (n=1)	100 (2.5 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment period: Extension Study

End point description

ACR 30 pediatric response: >=30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria:physician's global assessment(PGA) of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	12
Units: Percentage of subjects
arithmetic mean (confidence interval 95%)
Month 3 (n=12)	100 (73.5 to 100)
Month 6 (n=12)	100 (73.5 to 100)
Month 9 (n=12)	91.7 (61.5 to 99.8)
Month 12 (n=11)	90.9 (58.7 to 99.8)
Month 18 (n=10)	100 (69.2 to 100)
Month 24 (n=8)	100 (63.1 to 100)
Month 30 (n=9)	100 (66.4 to 100)
Month 36 (n=9)	100 (66.4 to 100)
Month 42 (n=5)	100 (47.8 to 100)
Month 48 (n=4)	100 (39.8 to 100)
Month 54 (n=4)	100 (39.8 to 100)
Month 60 (n=3)	100 (29.2 to 100)
Month 66 (n=4)	100 (39.8 to 100)
Month 72 (n=2)	100 (15.8 to 100)
Month 78 (n=1)	100 (2.5 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

End point description

ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment(PGA) of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The analysis set included all subjects enrolled in extension study. Here, “n” signifies subjects evaluable at specific time points. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	61
Units: Percentage of subjects
number (confidence interval 95%)
Month 6 (n=23)	95.7 (78.1 to 99.9)
Month 12 (n=60)	98.3 (91.1 to 100)
Month 18 (n=61)	96.7 (88.7 to 99.6)
Month 24 (n=56)	98.2 (90.4 to 100)
Month 30 (n=53)	98.1 (89.9 to 100)
Month 36 (n=47)	100 (92.5 to 100)
Month 42 (n=46)	93.5 (82.1 to 98.6)
Month 48 (n=42)	97.6 (87.4 to 99.9)
Month 54 (n=38)	100 (90.7 to 100)
Month 60 (n=33)	100 (89.4 to 100)
Month 66 (n=31)	100 (88.8 to 100)
Month 72 (n=25)	100 (86.3 to 100)
Month 78 (n=24)	100 (85.8 to 100)
Month 84 (n=21)	100 (83.9 to 100)
Month 90 (n=22)	100 (84.6 to 100)
Month 96 (n=16)	100 (79.4 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

End point description

ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment(PGA) of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Data for this endpoint was estimable till Week 72 only. Here, “n” signifies subjects evaluable at specific time points. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

End point values	Etanercept
Number of subjects analysed	23
Units: Percentage of subjects
number (confidence interval 95%)
Month 1 (n=23)	87.0 (66.4 to 97.2)
Month 3 (n=15)	100 (78.2 to 100)
Month 6 (n=11)	90.9 (58.7 to 99.8)
Month 9 (n=9)	88.9 (51.8 to 99.7)
Month 12 (n=9)	88.9 (51.8 to 99.7)
Month 18 (n=8)	87.5 (47.3 to 99.7)
Month 24 (n=5)	100 (47.8 to 100)
Month 30 (n=4)	100 (39.8 to 100)
Month 36 (n=3)	100 (29.2 to 100)
Month 42 (n=4)	100 (39.8 to 100)
Month 48 (n=3)	66.7 (9.4 to 99.2)
Month 54 (n=1)	100 (2.5 to 100)
Month 60 (n=1)	100 (2.5 to 100)
Month 66 (n=1)	100 (2.5 to 100)
Month 72 (n=1)	100 (2.5 to 100)
Month 96 (n=0)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

End point description

ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: physician's global assessment(PGA) of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	12
Units: Percentage of subjects
number (confidence interval 95%)
Month 3 (n=12)	100 (73.5 to 100)
Month 6 (n=12)	100 (73.5 to 100)
Month 9 (n=12)	91.7 (61.5 to 99.8)
Month 12 (n=11)	90.9 (58.7 to 99.8)
Month 18 (n=10)	100 (69.2 to 100)
Month 24 (n=8)	87.5 (47.3 to 99.7)
Month 30 (n=9)	100 (66.4 to 100)
Month 36 (n=9)	100 (66.4 to 100)
Month 42 (n=5)	100 (47.8 to 100)
Month 48 (n=4)	100 (39.8 to 100)
Month 54 (n=4)	100 (39.8 to 100)
Month 60 (n=3)	100 (29.2 to 100)
Month 66 (n=4)	100 (39.8 to 100)
Month 72 (n=2)	100 (15.8 to 100)
Month 78 (n=1)	100 (2.5 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

End point description

ACR Pedi 70 response: >=70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria:PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The analysis set included all subjects enrolled in the extension study. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	62
Units: Percentage of subjects
number (confidence interval 95%)
Month 6 (n=23)	95.7 (78.1 to 99.9)
Month 12 (n=62)	87.1 (76.1 to 94.3)
Month 18 (n=62)	88.7 (78.1 to 95.3)
Month 24 (n=55)	89.3 (78.1 to 96.0)
Month 30 (n=52)	88.5 (76.6 to 95.6)
Month 36 (n=47)	89.4 (76.9 to 96.5)
Month 42 (n=43)	88.4 (74.9 to 96.1)
Month 48 (n=41)	95.1 (83.5 to 99.4)
Month 54 (n=37)	100 (90.5 to 100)
Month 60 (n=33)	100 (89.4 to 100)
Month 66 (n=31)	100 (88.8 to 100)
Month 72 (n=26)	96.2 (80.4 to 99.9)
Month 78 (n=23)	100 (85.2 to 100)
Month 84 (n=20)	100 (83.2 to 100)
Month 90 (n=22)	90.9 (70.8 to 98.9)
Month 96 (n=15)	93.3 (68.1 to 99.8)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

End point description

ACR Pedi 70 response: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Data for this endpoint was estimable till Week 72 only. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

End point values	Etanercept
Number of subjects analysed	22
Units: Percentage of subjects
number (confidence interval 95%)
Month 1 (n=22)	77.3 (54.6 to 92.2)
Month 3 (n=15)	93.3 (68.1 to 99.8)
Month 6 (n=11)	90.9 (58.7 to 99.8)
Month 9 (n=9)	88.9 (51.8 to 99.7)
Month 12 (n=9)	88.9 (51.8 to 99.7)
Month 18 (n=7)	85.7 (42.1 to 99.6)
Month 24 (n=5)	100 (47.8 to 100)
Month 30 (n=4)	100 (39.8 to 100)
Month 36 (n=3)	100 (29.2 to 100)
Month 42 (n=4)	100 (39.8 to 100)
Month 48 (n=3)	66.7 (9.4 to 99.2)
Month 54 (n=1)	100 (2.5 to 100)
Month 60 (n=1)	100 (2.5 to 100)
Month 66 (n=1)	100 (2.5 to 100)
Month 72 (n=1)	100 (2.5 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

End point description

ACR Pedi 70 response: >=70% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Only data collected in the withdrawal period was included. Data for this endpoint was estimable till Week 78 only. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	12
Units: Percentage of subjects
number (confidence interval 95%)
Month 3 (n=12)	91.7 (61.5 to 99.8)
Month 6 (n=12)	83.3 (51.6 to 97.9)
Month 9 (n=11)	81.8 (48.2 to 97.7)
Month 12 (n=11)	81.8 (48.2 to 97.7)
Month 18 (n=10)	80.0 (44.4 to 97.5)
Month 24 (n=8)	75.0 (34.9 to 96.8)
Month 30 (n=9)	66.7 (29.9 to 92.5)
Month 36 (n=9)	88.9 (51.8 to 99.7)
Month 42 (n=6)	83.3 (35.9 to 99.6)
Month 48 (n=4)	100 (39.8 to 100)
Month 54 (n=4)	100 (39.8 to 100)
Month 60 (n=3)	100 (29.2 to 100)
Month 66 (n=3)	100 (29.2 to 100)
Month 72 (n=2)	100 (15.8 to 100)
Month 78 (n=1)	100 (2.5 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

End point description

ACR Pedi 90 response: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The analysis set included all subjects enrolled in the extension study. ere, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	62
Units: Percentage of subjects
number (confidence interval 95%)
Month 6 (n=25)	64.0 (42.5 to 82.0)
Month 12 (n=57)	70.2 (56.6 to 81.6)
Month 18 (n=62)	72.6 (59.8 to 83.1)
Month 24 (n=54)	64.8 (50.6 to 77.3)
Month 30 (n=52)	63.5 (49.0 to 76.4)
Month 36 (n=45)	71.1 (55.7 to 83.6)
Month 42 (n=43)	67.4 (51.5 to 80.9)
Month 48 (n=41)	65.9 (49.4 to 79.9)
Month 54 (n=31)	77.4 (58.9 to 90.4)
Month 60 (n=29)	89.7 (72.6 to 97.8)
Month 66 (n=24)	87.5 (67.6 to 97.3)
Month 72 (n=24)	75.0 (53.3 to 90.2)
Month 78 (n=17)	100 (80.5 to 100)
Month 84 (n=18)	77.8 (52.4 to 93.6)
Month 90 (n=20)	90.0 (68.3 to 98.8)
Month 96 (n=15)	86.7 (59.5 to 98.3)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

End point description

ACR Pedi 90 response: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria:PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

End point values	Etanercept
Number of subjects analysed	21
Units: Percentage of subjects
number (confidence interval 95%)
Month 1 (n=21)	66.7 (43.0 to 85.4)
Month 3 (n=14)	71.4 (41.9 to 91.6)
Month 6 (n=10)	70.0 (34.8 to 93.3)
Month 9 (n=8)	75.0 (34.9 to 96.8)
Month 12 (n=8)	87.5 (47.3 to 99.7)
Month 18 (n=8)	75.0 (34.9 to 96.8)
Month 24 (n=4)	100 (39.8 to 100)
Month 30 (n=4)	100 (39.8 to 100)
Month 36 (n=4)	75.0 (19.4 to 99.4)
Month 42 (n=4)	75.0 (19.4 to 99.4)
Month 48 (n=3)	66.7 (9.4 to 99.2)
Month 54 (n=2)	50.0 (1.3 to 98.7)
Month 60 (n=1)	100 (2.5 to 100)
Month 66 (n=1)	100 (2.5 to 100)
Month 72 (n=2)	50.0 (1.3 to 98.7)
Month 78 (n=1)	0.0 (0.0 to 97.5)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

End point description

ACR Pedi 90 response: >=90% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria:PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Data for this endpoint was estimable till Week 72 only. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	12
Units: Percentage of subjects
number (confidence interval 95%)
Month 3 (n=11)	63.6 (30.8 to 89.1)
Month 6 (n=12)	66.7 (34.9 to 90.1)
Month 9 (n=12)	66.7 (34.9 to 90.1)
Month 12 (n=10)	70.0 (34.8 to 93.3)
Month 18 (n=8)	75.0 (34.9 to 96.8)
Month 24 (n=7)	57.1 (18.4 to 90.1)
Month 30 (n=8)	62.5 (24.5 to 91.5)
Month 36 (n=8)	87.5 (47.3 to 99.7)
Month 42 (n=5)	60.0 (14.7 to 94.7)
Month 48 (n=4)	25.0 (0.6 to 80.6)
Month 54 (n=4)	50.0 (6.8 to 93.2)
Month 60 (n=4)	50.0 (6.8 to 93.2)
Month 66 (n=4)	50.0 (6.8 to 93.2)
Month 72 (n=3)	33.3 (0.8 to 90.6)
Month 78 (n=1)	100 (2.5 to 100)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

End point description

ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria: PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The analysis set included all subjects enrolled in the extension study. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	60
Units: Percentage of subjects
number (confidence interval 95%)
Month 6 (n=25)	44.0 (24.4 to 65.1)
Month 12 (n=54)	51.9 (37.8 to 65.7)
Month 18 (n=60)	55.0 (41.6 to 67.9)
Month 24 (n=55)	45.5 (32.0 to 59.4)
Month 30 (n=52)	40.4 (27.0 to 54.9)
Month 36 (n=36)	52.8 (35.5 to 69.6)
Month 42 (n=37)	48.6 (31.9 to 65.6)
Month 48 (n=35)	48.6 (31.4 to 66.0)
Month 54 (n=30)	56.7 (37.4 to 74.5)
Month 60 (n=24)	62.5 (40.6 to 81.2)
Month 66 (n=21)	57.1 (34.0 to 78.2)
Month 72 (n=18)	38.9 (17.3 to 64.3)
Month 78 (n=16)	75.0 (47.6 to 92.7)
Month 84 (n=15)	53.3 (26.6 to 78.7)
Month 90 (n=14)	71.4 (41.9 to 91.6)
Month 96 (n=9)	77.8 (40.0 to 97.2)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

End point description

ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria:PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Data for this endpoint was estimable till Week 72 only. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72

End point values	Etanercept
Number of subjects analysed	21
Units: Percentage of subjects
number (confidence interval 95%)
Month 1 (n=21)	61.9 (38.4 to 81.9)
Month 3 (n=14)	64.3 (35.1 to 87.2)
Month 6 (n=11)	63.6 (30.8 to 89.1)
Month 9 (n=9)	66.7 (29.9 to 92.5)
Month 12 (n=9)	77.8 (40.0 to 97.2)
Month 18 (n=9)	66.7 (29.9 to 92.5)
Month 24 (n=5)	80.0 (28.4 to 99.5)
Month 30 (n=5)	80.0 (28.4 to 99.5)
Month 36 (n=4)	75.0 (19.4 to 99.4)
Month 42 (n=5)	60.0 (14.7 to 94.7)
Month 48 (n=4)	50.0 (6.8 to 93.2)
Month 54 (n=2)	50.0 (1.3 to 98.7)
Month 60 (n=1)	100 (2.5 to 100)
Month 66 (n=1)	100 (2.5 to 100)
Month 72 (n=2)	50.0 (1.3 to 98.7)
Month 78 (n=1)	0.0 (0.0 to 97.5)

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Top of page

End point title

Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

End point description

ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening >30% in no more than 1 of 6 criteria:PGA of disease activity, parent/patient global assessment of arthritis pain, childhood health assessment questionnaire (CHAQ), number of active joints, number of joints with limited range of motion and C-reactive protein. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Data for this endpoint was estimable till Week 78 only. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	12
Units: Percentage of subjects
number (confidence interval 95%)
Month 3 (n=11)	54.5 (23.4 to 83.3)
Month 6 (n=12)	50.0 (21.1 to 78.9)
Month 9 (n=11)	63.6 (30.8 to 89.1)
Month 12 (n=8)	62.5 (24.5 to 91.5)
Month 18 (n=8)	75.0 (34.9 to 96.8)
Month 24 (n=7)	57.1 (18.4 to 90.1)
Month 30 (n=7)	57.1 (18.4 to 90.1)
Month 36 (n=8)	87.5 (47.3 to 99.7)
Month 42 (n=5)	60.0 (14.7 to 94.7)
Month 48 (n=4)	25.0 (0.6 to 80.6)
Month 54 (n=4)	50.0 (6.8 to 93.2)
Month 60 (n=4)	50.0 (6.8 to 93.2)
Month 66 (n=4)	50.0 (6.8 to 93.2)
Month 72 (n=3)	33.3 (0.8 to 90.6)
Month 78 (n=1)	100 (2.5 to 100)

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: All Periods: Extension Study

End point description

PGA of Disease Activity was measured on a VAS ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity, where higher scores indicated greater disease activity. The analysis set included all subjects enrolled in the the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	98
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=98)	-4.29 ( 1.87 )
Month 6 (n=96)	-4.51 ( 1.63 )
Month 12 (n=86)	-4.66 ( 1.83 )
Month 18 (n=73)	-4.71 ( 2.10 )
Month 24 (n=63)	-4.67 ( 1.73 )
Month 30 (n=60)	-4.69 ( 1.94 )
Month 36 (n=57)	-4.75 ( 1.72 )
Month 42 (n=53)	-4.71 ( 2.00 )
Month 48 (n=49)	-4.80 ( 1.79 )
Month 54 (n=42)	-5.05 ( 1.82 )
Month 60 (n=39)	-5.19 ( 1.64 )
Month 66 (n=36)	-5.10 ( 1.80 )
Month 72 (n=34)	-5.21 ( 1.81 )
Month 78 (n=30)	-5.15 ( 1.58 )
Month 84 (n=29)	-5.17 ( 1.69 )
Month 90 (n=27)	-5.15 ( 1.67 )
Month 96 (n=23)	-5.11 ( 1.65 )

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Withdrawal Period: Extension Study

End point description

PGA of Disease Activity was measured on a VAS ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity, where higher scores indicated greater disease activity. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Data for this endpoint was estimable till Week 78 only. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points. 99999 signifies that standard deviation was not estimable as only 1 subject was evaluated.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Withdrawal Period
Number of subjects analysed	28
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 28)	-5.29 ( 1.98 )
Month 1 (n=24)	-4.92 ( 2.35 )
Month 3 (n=15,)	-4.70 ( 2.40 )
Month 6 (n=12)	-5.50 ( 1.99 )
Month 9 (n=11)	-5.09 ( 2.17 )
Month 12 (n=10)	-5.30 ( 2.14 )
Month 18 (n=10)	-5.15 ( 2.42 )
Month 24 (n=8)	-4.88 ( 2.05 )
Month 30 (n=7)	-4.50 ( 1.89 )
Month 36 (n=7)	-4.50 ( 1.89 )
Month 42 (n=6)	-4.33 ( 2.09 )
Month 48 (n=4)	-5.13 ( 2.10 )
Month 54 (n=3)	-5.33 ( 2.52 )
Month 60 (n=3)	-5.67 ( 2.08 )
Month 66 (n=2)	-6.00 ( 2.83 )
Month 72 (n=2)	-4.50 ( 2.12 )
Month 78 (n=1)	-2.50 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Re-treatment Period: Extension Study

End point description

PGA of Disease Activity was measured on a VAS ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity, where higher scores indicated greater disease activity. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Data for this endpoint was estimable till Week 78 only. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points. 99999 signifies that standard deviation was not estimable as only 1 subject was evaluated.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	12
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=12)	-0.92 ( 2.33 )
Month 3 (n=13)	-3.73 ( 1.51 )
Month 6 (n=13)	-4.19 ( 1.53 )
Month 9 (n=12)	-4.13 ( 2.05 )
Month 12 (n=11)	-3.82 ( 2.69 )
Month 18 (n=10)	-3.85 ( 2.17 )
Month 24 (n=8)	-3.81 ( 2.55 )
Month 30 (n=9)	-3.94 ( 2.30 )
Month 36 (n=9)	-4.11 ( 2.16 )
Month 42 (n=7)	-4.14 ( 2.53 )
Month 48 (n=6)	-3.58 ( 1.86 )
Month 54 (n=6)	-3.42 ( 1.43 )
Month 60 (n=5)	-2.60 ( 0.74 )
Month 66 (n=4)	-2.63 ( 0.85 )
Month 72 (n=3)	-2.33 ( 0.76 )
Month 78 (n=1)	-3.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: All Periods: Extension Study

End point description

Patient/Parent Global Assessment was assessed by the subject's parent using a VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. The analysis set included all subjects enrolled in extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	98
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=98)	-3.59 ( 2.42 )
Month 6 (n=96)	-3.93 ( 2.31 )
Month 12 (n=85)	-3.79 ( 2.49 )
Month 18 (n=71)	-4.13 ( 2.49 )
Month 24 (n=64)	-4.18 ( 2.60 )
Month 30 (n=61)	-4.38 ( 2.27 )
Month 36 (n=57)	-4.20 ( 2.24 )
Month 42 (n=51)	-4.05 ( 2.85 )
Month 48 (n=49)	-4.37 ( 2.29 )
Month 54 (n=42)	-4.74 ( 2.33 )
Month 60 (n=38)	-4.45 ( 2.57 )
Month 66 (n=36)	-4.54 ( 2.54 )
Month 72 (n=34)	-4.50 ( 2.63 )
Month 78 (n=30)	-4.62 ( 1.87 )
Month 84 (n=29)	-4.57 ( 1.90 )
Month 90 (n=27)	-4.72 ( 2.08 )
Month 96 (n=23)	-4.85 ( 2.11 )

No statistical analyses for this end point

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Withdrawal Period: Extension Study

End point description

Patient/Parent Global Assessment was assessed by the subject's parent using a VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Withdrawal Period
Number of subjects analysed	28
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 28)	-4.50 ( 2.45 )
Month 1 (n=24)	-4.38 ( 2.77 )
Month 3 (n=15)	-3.97 ( 2.88 )
Month 6 (n=12)	-5.04 ( 2.58 )
Month 9 (n=10)	-4.65 ( 2.73 )
Month 12 (n=10)	-4.60 ( 2.77 )
Month 18 (n=10)	-4.50 ( 2.84 )
Month 24 (n=8)	-4.63 ( 2.75 )
Month 30 (n=7)	-4.07 ( 2.41 )
Month 36 (n=7)	-4.14 ( 2.66 )
Month 42 (n=6)	-3.83 ( 2.77 )
Month 48 (n=4)	-3.25 ( 3.77 )
Month 54 (n=3)	-4.00 ( 3.77 )
Month 60 (n=3)	-4.00 ( 4.00 )
Month 66 (n=2)	-4.00 ( 5.66 )
Month 72 (n=2)	-4.25 ( 5.30 )
Month 78 (n=1)	-0.50 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Re-treatment Period: Extension Study

End point description

Patient/Parent Global Assessment was assessed by the subject's parent using a VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	12
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 12)	-1.04 ( 2.97 )
Month 3 (n=13)	-2.81 ( 1.95 )
Month 6 (n=13)	-2.73 ( 2.26 )
Month 9 (n=12)	-2.83 ( 2.79 )
Month 12 (n=11)	-2.86 ( 3.03 )
Month 18 (n=10)	-2.65 ( 2.65 )
Month 24 (n=8)	-2.81 ( 2.90 )
Month 30 (n=9)	-2.44 ( 2.86 )
Month 36 (n=9)	-2.83 ( 2.63 )
Month 42 (n=7)	-2.93 ( 3.06 )
Month 48 (n=6)	-2.17 ( 2.36 )
Month 54 (n=6)	-2.33 ( 1.99 )
Month 60 (n=5)	-1.30 ( 1.20 )
Month 66 (n=4)	-1.13 ( 0.95 )
Month 72 (n=3)	-1.50 ( 1.00 )
Month 78 (n=1)	-2.50 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Score for Subjects Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Score for Subjects Through Month 96: All Periods: Extension Study

End point description

Childhood Health Assessment Questionnaire (CHAQ): parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subject's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, reach,grip,common activities distributed in 30 items. Each item scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain. Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	80
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=80)	-0.61 ( 0.60 )
Month 6 (n=74)	-0.66 ( 0.60 )
Month 12 (n=62)	-0.71 ( 0.58 )
Month 18 (n=46)	-0.72 ( 0.56 )
Month 24 (n=37)	-0.81 ( 0.59 )
Month 30 (n=32)	-0.82 ( 0.57 )
Month 36 (n=22)	-0.86 ( 0.60 )
Month 42 (n=21)	-0.81 ( 0.67 )
Month 48 (n=16)	-0.97 ( 0.69 )
Month 54 (n=10)	-1.15 ( 0.75 )
Month 60 (n=8)	-1.33 ( 0.81 )
Month 66 (n=7)	-1.48 ( 0.75 )
Month 72 (n=6)	-1.50 ( 0.76 )
Month 78 (n=5)	-1.40 ( 0.71 )
Month 84 (n=4)	-1.41 ( 0.83 )
Month 90 (n=4)	-1.41 ( 0.83 )
Month 96 (n=2)	-1.13 ( 1.24 )

No statistical analyses for this end point

Secondary: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Score for Subjects Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Score for Subjects Through Month 96: Withdrawal Period: Extension Study

End point description

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subject's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in 30 items. Each item scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain. Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points. 99999 signifies that standard deviation was not estimable as only 1 subject was evaluated.

End point type

Secondary

End point timeframe

Baseline through Month 96

End point values	Etanercept
Number of subjects analysed	17
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 17)	-0.88 ( 0.77 )
Month 1 (n=15)	-0.81 ( 0.86 )
Month 3 (n=9)	-0.90 ( 0.82 )
Month 6 (n=6)	-1.04 ( 0.95 )
Month 9 (n=6)	-1.04 ( 1.09 )
Month 12 (n=15)	-1.15 ( 1.16 )
Month 18 (n=5)	-1.15 ( 1.16 )
Month 24 (n=1)	-2.13 ( 99999 )
Month 30 (n=1)	-2.13 ( 99999 )
Month 36 (n=1)	-2.13 ( 99999 )
Month 42 (n=1)	-2.13 ( 99999 )
Month 48 (n=1)	-2.13 ( 99999 )
Month 54 (n=1)	-2.13 ( 99999 )
Month 60 (n=1)	-2.13 ( 99999 )
Month 66 (n=1)	-2.13 ( 99999 )
Month 72 (n=1)	-2.13 ( 99999 )
Month 78 (n=1)	-2.13 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Score for Subjects Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Score for Subjects Through Month 96: Re-treatment Period: Extension Study

End point description

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subject's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in 30 items. Each item scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain. Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	11
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 9)	-0.39 ( 0.70 )
Month 3 (n=11)	-0.65 ( 0.66 )
Month 6 (n=10)	-0.66 ( 0.73 )
Month 9 (n=8)	-0.78 ( 0.79 )
Month 12 (n=8)	-0.80 ( 0.78 )
Month 18 (n=8)	-0.78 ( 0.79 )
Month 24 (n=7)	-0.75 ( 0.85 )
Month 30 (n=6)	-0.79 ( 0.92 )
Month 36 (n=6)	-0.88 ( 0.87 )
Month 42 (n=4)	-0.94 ( 1.11 )
Month 48 (n=3)	-0.42 ( 0.62 )
Month 54 (n=3)	-0.42 ( 0.62 )
Month 60 (n=2)	-0.06 ( 0.09 )
Month 66 (n=2)	-0.06 ( 0.09 )
Month 72 (n=1)	-0.13 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Subjects Years Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Subjects Years Through Month 96: All Periods: Extension Study

End point description

HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	109
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=11)	0.10 ( 0.23 )
Month 6 (n=10)	0.09 ( 0.19 )
Month 12 (n=10)	0.10 ( 0.16 )
Month 18 (n=8)	0.09 ( 0.19 )
Month 24 (n=6)	0.13 ( 0.19 )
Month 30 (n=6)	0.15 ( 0.23 )
Month 36 (n=6)	0.17 ( 0.27 )
Month 42 (n=6)	0.13 ( 0.25 )
Month 48 (n=6)	0.17 ( 0.27 )
Month 54 (n=5)	0.13 ( 0.18 )
Month 60 (n=5)	0.18 ( 0.24 )
Month 66 (n=3)	0.33 ( 0.31 )
Month 72 (n=3)	0.29 ( 0.26 )
Month 78 (n=3)	0.13 ( 0.22 )
Month 84 (n=3)	0.25 ( 0.33 )
Month 90 (n=2)	0.13 ( 0.18 )
Month 96 (n=1)	0.63 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Subjects Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Subjects Through Month 96: Withdrawal Period: Extension Study

End point description

Health Assessment Questionnaire (HAQ): self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept
Number of subjects analysed	11
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 11, 3)	0.00 ( 0.00 )
Month 1 (n=9)	0.00 ( 0.00 )
Month 3 (n=6)	0.02 ( 0.05 )
Month 6 (n=5)	0.03 ( 0.06 )
Month 9 (n=4)	0.00 ( 0.00 )
Month 12 (n=4)	0.00 ( 0.00 )
Month 18 (n=4)	0.00 ( 0.00 )
Month 24 (n=4)	0.00 ( 0.00 )
Month 30 (n=3)	0.04 ( 0.07 )
Month 36 (n=3)	0.00 ( 0.00 )
Month 42 (n=3)	0.00 ( 0.00 )
Month 48 (n=1)	0.00 ( 0.00 )
Month 54 (n=1)	0.00 ( 0.00 )
Month 60 (n=1)	0.00 ( 0.00 )
Month 66 (n=0)	99999 ( 99999 )
Month 72 (n=0)	99999 ( 99999 )
Month 78 (n=0)	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Subjects Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Subjects Through Month 96: Re-treatment Period: Extension Study

End point description

Health Assessment Questionnaire (HAQ): self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept
Number of subjects analysed	3
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=3)	0.79 ( 0.07 )
Month 3 (n=2)	-0.81 ( 0.09 )
Month 6 (n=2)	-0.81 ( 0.09 )
Month 9 (n=3)	-0.42 ( 0.69 )
Month 12 (n=2)	-0.81 ( 0.09 )
Month 18 (n=1)	-0.75 ( 99999 )
Month 24 (n=1)	-0.75 ( 99999 )
Month 30 (n=1)	-0.75 ( 99999 )
Month 36 (n=1)	-0.75 ( 99999 )
Month 42 (n=1)	-0.75 ( 99999 )
Month 48 (n=1)	-0.75 ( 99999 )
Month 54 (n=1)	-0.75 ( 99999 )
Month 60 (n=1)	-0.75 ( 99999 )
Month 66 (n=1)	-0.75 ( 99999 )
Month 72 (n=1)	-0.75 ( 99999 )
Month 78 (n=1)	-0.75 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Joints With Active Arthritis Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Number of Joints With Active Arthritis Through Month 96: All Periods: Extension Study

End point description

Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	87
Units: Joints
arithmetic mean (standard deviation)
Baseline (n=87)	-6.25 ( 4.89 )
Month 6 (n=25)	-7.00 ( 5.92 )
Month 12 (n=67)	-6.94 ( 5.59 )
Month 18 (n=72)	-6.82 ( 5.39 )
Month 24 (n=65)	-6.48 ( 4.64 )
Month 30 (n=61)	-6.43 ( 4.41 )
Month 36 (n=56)	-6.82 ( 4.46 )
Month 42 (n=52)	-6.98 ( 4.78 )
Month 48 (n=49)	-7.27 ( 4.56 )
Month 54 (n=42)	-7.71 ( 4.93 )
Month 60 (n=39)	-7.74 ( 4.51 )
Month 66 (n=36)	-7.56 ( 4.35 )
Month 72 (n=34)	-7.56 ( 4.24 )
Month 78 (n=30)	-7.40 ( 3.83 )
Month 84 (n=29)	-7.14 ( 3.74 )
Month 90 (n=27)	-7.37 ( 3.69 )
Month 96 (n=23)	-7.17 ( 3.58 )

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Joints With Active Arthritis Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Number of Joints With Active Arthritis Through Month 96: Withdrawal Period: Extension Study

End point description

Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Withdrawal Period
Number of subjects analysed	28
Units: Joints
arithmetic mean (standard deviation)
Baseline (n= 28)	-7.54 ( 4.61 )
Month 1 (n=24)	-6.96 ( 5.38 )
Month 3 (n=15)	-8.53 ( 5.48 )
Month 6 (n=12)	-8.50 ( 4.80 )
Month 9 (n=11)	-8.73 ( 4.96 )
Month 12 (n=10)	-8.70 ( 5.27 )
Month 18 (n=10)	-8.40 ( 5.19 )
Month 24 (n=8)	-8.38 ( 4.69 )
Month 30 (n=7)	-7.00 ( 2.83 )
Month 36 (n=7)	-6.86 ( 3.02 )
Month 42 (n=6)	-7.17 ( 2.99 )
Month 48 (n=4)	-6.75 ( 2.75 )
Month 54 (n=3)	-6.67 ( 3.06 )
Month 60 (n=3)	-7.00 ( 3.00 )
Month 66 (n=2)	-8.50 ( 2.12 )
Month 72 (n=2)	-7.50 ( 2.12 )
Month 78 (n=1)	-5.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Joints With Active Arthritis Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Number of Joints With Active Arthritis Through Month 96: Re-treatment Period: Extension Study

End point description

Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	13
Units: Joints
arithmetic mean (standard deviation)
Baseline (n=12)	-1.17 ( 7.25 )
Month 3 (n=13)	-6.31 ( 4.31 )
Month 6 (n=13)	-6.46 ( 4.29 )
Month 9 (n=12)	-6.17 ( 4.73 )
Month 12 (n=11)	-6.18 ( 4.92 )
Month 18 (n=10)	-6.60 ( 4.97 )
Month 24 (n=8)	-5.63 ( 2.62 )
Month 30 (n=9)	-5.33 ( 2.50 )
Month 36 (n=9)	-5.67 ( 2.35 )
Month 42 (n=7)	-5.86 ( 2.54 )
Month 48 (n=6)	-5.33 ( 1.97 )
Month 54 (n=6)	-5.33 ( 1.97 )
Month 60 (n=5)	-4.60 ( 0.89 )
Month 66 (n=4)	-4.75 ( 0.96 )
Month 72 (n=3)	-4.33 ( 0.58 )
Month 78 (n=1)	-5.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Joints With Limited Motion Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Number of Joints With Limited Motion Through Month 96: All Periods: Extension Study

End point description

Total number of joints with limited range of motion was the number of joints with limited range of motion prorated for missing limited range of motions. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	87
Units: Joints
arithmetic mean (standard deviation)
Baseline (n=87)	-4.74 ( 4.45 )
Month 6 (n=25)	-4.80 ( 5.39 )
Month 12 (n=67)	-5.51 ( 5.18 )
Month 18 (n=72)	-5.32 ( 5.27 )
Month 24 (n=65)	-5.12 ( 4.83 )
Month 30 (n=61)	-5.03 ( 4.19 )
Month 36 (n=56)	-5.23 ( 4.26 )
Month 42 (n=52)	-5.63 ( 4.69 )
Month 48 (n=49)	-5.90 ( 4.33 )
Month 54 (n=42)	-6.57 ( 4.71 )
Month 60 (n=39)	-6.38 ( 4.02 )
Month 66 (n=36)	-6.64 ( 3.86 )
Month 72 (n=34)	-6.71 ( 4.11 )
Month 78 (n=30)	-6.90 ( 4.15 )
Month 84 (n=29)	-6.45 ( 4.15 )
Month 90 (n=27)	-6.63 ( 3.82 )
Month 96 (n=23)	-6.57 ( 3.72 )

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Joints With Limited Motion Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Number of Joints With Limited Motion Through Month 96: Withdrawal Period: Extension Study

End point description

Total number of joints with limited range of motion was the number of joints with limited range of motion prorated for missing limited range of motions. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Withdrawal Period
Number of subjects analysed	28
Units: Joints
arithmetic mean (standard deviation)
Baseline (n= 28)	-5.50 ( 4.40 )
Month 1 (n=24)	-5.38 ( 4.68 )
Month 3 (n=15)	-5.60 ( 5.15 )
Month 6 (n=12)	-5.67 ( 3.68 )
Month 9 (n=11)	-5.36 ( 3.70 )
Month 12 (n=10)	-5.40 ( 4.01 )
Month 18 (n=10)	-5.10 ( 3.54 )
Month 24 (n=8)	-4.75 ( 3.20 )
Month 30 (n=7)	-4.71 ( 3.45 )
Month 36 (n=7)	-4.71 ( 3.45 )
Month 42 (n=6)	-4.83 ( 3.76 )
Month 48 (n=4)	-3.25 ( 4.03 )
Month 54 (n=3)	-2.00 ( 1.00 )
Month 60 (n=3)	-1.67 ( 1.15 )
Month 66 (n=2)	-2.00 ( 1.41 )
Month 72 (n=2)	-2.00 ( 1.41 )
Month 78 (n=1)	1.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Number of Joints With Limited Motion Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Number of Joints With Limited Motion Through Month 96: Re-treatment Period: Extension Study

End point description

Total number of joints with limited range of motion was the number of joints with limited range of motion prorated for missing limited range of motions. It was defined as 69*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	13
Units: Joints
arithmetic mean (standard deviation)
Baseline (n=12)	-1.25 ( 6.41 )
Month 3 (n=13)	-5.15 ( 4.83 )
Month 6 (n=13)	-5.46 ( 4.82 )
Month 9 (n=12)	-4.75 ( 5.59 )
Month 12 (n=11)	-5.45 ( 5.48 )
Month 18 (n=10)	-5.60 ( 5.60 )
Month 24 (n=8)	-3.88 ( 4.45 )
Month 30 (n=9)	-3.78 ( 4.18 )
Month 36 (n=9)	-4.44 ( 3.97 )
Month 42 (n=7)	-4.71 ( 4.39 )
Month 48 (n=6)	-3.83 ( 3.87 )
Month 54 (n=6)	-3.83 ( 3.87 )
Month 60 (n=5)	-2.80 ( 2.86 )
Month 66 (n=4)	-3.00 ( 2.94 )
Month 72 (n=3)	-2.00 ( 2.65 )
Month 78 (n=1)	-1.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in C-reactive Protein Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in C-reactive Protein Through Month 96: All Periods: Extension Study

End point description

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	92
Units: mg/Liter (mg/L)
arithmetic mean (standard deviation)
Baseline (n=92)	-3.62 ( 12.51 )
Month 6 (n=93)	-3.71 ( 12.20 )
Month 12 (n=82)	-3.37 ( 13.01 )
Month 18 (n=71)	-3.82 ( 15.17 )
Month 24 (n=64)	-4.00 ( 13.89 )
Month 30 (n=61)	-3.89 ( 12.93 )
Month 36 (n=55)	-3.52 ( 14.91 )
Month 42 (n=53)	-1.96 ( 22.18 )
Month 48 (n=49)	-5.01 ( 14.61 )
Month 54 (n=42)	-5.79 ( 15.49 )
Month 60 (n=39)	-3.25 ( 13.28 )
Month 66 (n=36)	-4.39 ( 13.61 )
Month 72 (n=31)	-4.64 ( 13.76 )
Month 78 (n=27)	-4.31 ( 11.17 )
Month 84 (n=28)	-4.52 ( 15.32 )
Month 90 (n=27)	-5.37 ( 15.17 )
Month 96 (n=22)	-0.59 ( 22.63 )

No statistical analyses for this end point

Secondary: Change From Baseline in C-reactive Protein Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in C-reactive Protein Through Month 96: Withdrawal Period: Extension Study

End point description

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept
Number of subjects analysed	27
Units: mg/Liter (mg/L)
arithmetic mean (standard deviation)
Baseline (n= 27)	-6.28 ( 9.22 )
Month 1 (n=22)	-0.99 ( 14.06 )
Month 3 (n=15)	-2.47 ( 6.73 )
Month 6 (n=12)	-3.01 ( 6.89 )
Month 9 (n=11)	-0.27 ( 1.26 )
Month 12 (n=10)	-0.25 ( 1.19 )
Month 18 (n=10)	0.07 ( 2.07 )
Month 24 (n=8)	0.14 ( 1.61 )
Month 30 (n=7)	1.19 ( 2.48 )
Month 36 (n=6)	0.15 ( 1.13 )
Month 42 (n=6)	4.68 ( 10.74 )
Month 48 (n=4)	1.26 ( 4.35 )
Month 54 (n=3)	-0.06 ( 0.82 )
Month 60 (n=3)	0.23 ( 1.15 )
Month 66 (n=2)	-0.10 ( 1.27 )
Month 72 (n=1)	2.80 ( 99999 )
Month 78 (n=1)	-0.40 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in C-reactive Protein Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in C-reactive Protein Through Month 96: Re-treatment Period: Extension Study

End point description

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	13
Units: mg/L
arithmetic mean (standard deviation)
Baseline (n=12)	0.32 ( 12.34 )
Month 3 (n=11)	-5.50 ( 11.59 )
Month 6 (n=13)	-5.99 ( 9.03 )
Month 9 (n=12)	-6.42 ( 9.72 )
Month 12 (n=11)	-6.91 ( 9.46 )
Month 18 (n=10)	-6.68 ( 8.88 )
Month 24 (n=8)	-7.79 ( 10.69 )
Month 30 (n=9)	-6.13 ( 11.41 )
Month 36 (n=9)	-5.18 ( 11.87 )
Month 42 (n=7)	2.76 ( 28.99 )
Month 48 (n=6)	0.60 ( 18.68 )
Month 54 (n=6)	0.22 ( 19.92 )
Month 60 (n=5)	20.44 ( 46.78 )
Month 66 (n=4)	-0.10 ( 0.58 )
Month 72 (n=3)	0.57 ( 2.54 )
Month 78 (n=2)	5.30 ( 8.63 )

No statistical analyses for this end point

Secondary: Change From Baseline in Visual Analogue Scale (VAS) Pain Score Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Visual Analogue Scale (VAS) Pain Score Through Month 96: All Periods: Extension Study

End point description

Change from Baseline in VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity. Change = scores at observation minus score at Baseline. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	78
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=78)	-3.94 ( 2.52 )
Month 6 (n=15)	-3.43 ( 2.05 )
Month 12 (n=54)	-4.02 ( 2.52 )
Month 18 (n=64)	-4.24 ( 2.58 )
Month 24 (n=57)	-4.40 ( 2.44 )
Month 30 (n=58)	-4.26 ( 2.50 )
Month 36 (n=56)	-4.03 ( 2.55 )
Month 42 (n=50)	-3.82 ( 3.21 )
Month 48 (n=49)	-4.15 ( 2.55 )
Month 54 (n=42)	-4.51 ( 2.65 )
Month 60 (n=39)	-4.36 ( 2.44 )
Month 66 (n=36)	-4.26 ( 2.67 )
Month 72 (n=34)	-4.19 ( 2.58 )
Month 78 (n=30)	-4.25 ( 2.17 )
Month 84 (n=29)	-4.09 ( 2.26 )
Month 90 (n=27)	-4.20 ( 2.60 )
Month 96 (n=23)	-4.39 ( 2.36 )

No statistical analyses for this end point

Secondary: Change From Baseline in Visual Analogue Scale (VAS) Pain Score Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Visual Analogue Scale (VAS) Pain Score Through Month 96: Withdrawal Period: Extension Study

End point description

Change from Baseline in VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity. Change = scores at observation minus score at Baseline. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept
Number of subjects analysed	26
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 26)	-4.62 ( 2.69 )
Month 1 (n=22)	-4.75 ( 2.79 )
Month 3 (n=15)	-4.03 ( 2.97 )
Month 6 (n=11)	-5.00 ( 2.66 )
Month 9 (n=11)	-4.36 ( 2.93 )
Month 12 (n=10)	-4.70 ( 2.80 )
Month 18 (n=10)	-4.50 ( 2.89 )
Month 24 (n=8)	-3.81 ( 2.49 )
Month 30 (n=7)	-3.36 ( 3.00 )
Month 36 (n=7)	-4.00 ( 2.93 )
Month 42 (n=6)	-3.67 ( 3.06 )
Month 48 (n=4)	-2.50 ( 3.54 )
Month 54 (n=3)	-3.67 ( 3.25 )
Month 60 (n=3)	-3.50 ( 3.50 )
Month 66 (n=2)	-3.75 ( 4.60 )
Month 72 (n=2)	-3.75 ( 4.60 )
Month 78 (n=1)	-0.50 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Visual Analogue Scale (VAS) Pain Score Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Visual Analogue Scale (VAS) Pain Score Through Month 96: Re-treatment Period: Extension Study

End point description

Change from Baseline in VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity. Change = scores at observation minus score at Baseline. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points. 99999 signifies that standard deviation was not estimable as only 1 subject was evaluated.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	13
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=11)	-0.23 ( 3.97 )
Month 3 (n=11)	-2.64 ( 2.68 )
Month 6 (n=13)	-2.65 ( 3.20 )
Month 9 (n=11)	-2.68 ( 2.92 )
Month 12 (n=10)	-3.05 ( 3.72 )
Month 18 (n=10)	-2.25 ( 3.23 )
Month 24 (n=8)	-2.25 ( 3.01 )
Month 30 (n=8)	-2.13 ( 3.06 )
Month 36 (n=7)	-2.29 ( 3.44 )
Month 42 (n=7)	-2.57 ( 3.05 )
Month 48 (n=6)	-1.75 ( 1.89 )
Month 54 (n=6)	-1.75 ( 2.12 )
Month 60 (n=5)	-0.90 ( 0.42 )
Month 66 (n=4)	-0.50 ( 0.71 )
Month 72 (n=3)	-0.83 ( 0.76 )
Month 78 (n=1)	0.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Duration of Morning Stiffness Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Duration of Morning Stiffness Through Month 96: All Periods: Extension Study

End point description

Duration of morning stiffness was defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	80
Units: Minutes
arithmetic mean (standard deviation)
Baseline (n=80)	-61.78 ( 90.07 )
Month 6 (n=19)	-52.11 ( 56.63 )
Month 12 (n=57)	-73.33 ( 110.91 )
Month 18 (n=67)	-80.24 ( 108.79 )
Month 24 (n=63)	-72.19 ( 105.84 )
Month 30 (n=59)	-66.36 ( 110.79 )
Month 36 (n=56)	-75.04 ( 112.27 )
Month 42 (n=52)	-73.75 ( 111.59 )
Month 48 (n=49)	-76.22 ( 118.95 )
Month 54 (n=42)	-82.21 ( 124.19 )
Month 60 (n=39)	-89.10 ( 126.62 )
Month 66 (n=36)	-95.56 ( 134.35 )
Month 72 (n=34)	-89.26 ( 148.76 )
Month 78 (n=30)	-91.17 ( 141.86 )
Month 84 (n=29)	-91.83 ( 143.82 )
Month 90 (n=27)	-101.85 ( 140.75 )
Month 96 (n=23)	-99.78 ( 152.26 )

No statistical analyses for this end point

Secondary: Change From Baseline in Duration of Morning Stiffness Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Duration of Morning Stiffness Through Month 96: Withdrawal Period: Extension Study

End point description

Duration of morning stiffness was defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept
Number of subjects analysed	27
Units: Minutes
arithmetic mean (standard deviation)
Baseline (n= 27)	-85.74 ( 109.45 )
Month 1 (n=23)	-83.96 ( 119.42 )
Month 3 (n=14)	-71.43 ( 98.85 )
Month 6 (n=12)	-56.67 ( 62.32 )
Month 9 (n=11)	-29.09 ( 26.72 )
Month 12 (n=10)	-32.00 ( 26.27 )
Month 18 (n=10)	-32.00 ( 26.27 )
Month 24 (n=8)	-30.63 ( 29.33 )
Month 30 (n=7)	-30.71 ( 31.68 )
Month 36 (n=7)	-30.71 ( 31.68 )
Month 42 (n=6)	-25.83 ( 31.69 )
Month 48 (n=4)	-31.25 ( 37.50 )
Month 54 (n=6)	-41.67 ( 38.19 )
Month 60 (n=3)	-41.67 ( 38.19 )
Month 66 (n=2)	-25.00 ( 35.36 )
Month 72 (n=2)	-25.00 ( 35.36 )
Month 78 (n=1)	0.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Duration of Morning Stiffness Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Duration of Morning Stiffness Through Month 96: Re-treatment Period: Extension Study

End point description

Duration of morning stiffness was defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	13
Units: Minutes
arithmetic mean (standard deviation)
Baseline (n=13)	-57.92 ( 137.89 )
Month 3 (n=13)	-116.15 ( 138.82 )
Month 6 (n=13)	-107.69 ( 147.90 )
Month 9 (n=12)	-126.67 ( 144.23 )
Month 12 (n=11)	-130.00 ( 151.53 )
Month 18 (n=10)	-111.00 ( 142.53 )
Month 24 (n=8)	-85.63 ( 137.98 )
Month 30 (n=9)	-72.22 ( 142.55 )
Month 36 (n=8)	-89.38 ( 135.24 )
Month 42 (n=7)	-101.43 ( 140.88 )
Month 48 (n=6)	-60.00 ( 94.45 )
Month 54 (n=6)	-60.00 ( 94.45 )
Month 60 (n=5)	-24.00 ( 37.82 )
Month 66 (n=4)	-7.50 ( 9.57 )
Month 72 (n=3)	-10.00 ( 10.00 )
Month 78 (n=1)	-20.00 ( 99999 )

No statistical analyses for this end point

Secondary: Percentage of Subjects With Clinically Inactive Disease Through Month 96: All Periods: Extension Study

Top of page

End point title

Percentage of Subjects With Clinically Inactive Disease Through Month 96: All Periods: Extension Study

End point description

Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	109
Units: Percentage of subjects
number (confidence interval 95%)
Month 6 (n=68)	11.8 (5.2 to 21.9)
Month 12 (n=70)	25.7 (16.0 to 37.6)
Month 18 (n=69)	36.2 (25.0 to 48.7)
Month 24 (n=62)	24.2 (14.2 to 36.7)
Month 30 (n=59)	30.5 (19.2 to 43.9)
Month 36 (n=56)	32.1 (20.3 to 46.0)
Month 42 (n=53)	32.1 (19.9 to 46.3)
Month 48 (n=49)	28.6 (16.6 to 43.3)
Month 54 (n=42)	33.3 (19.6 to 49.5)
Month 60 (n=39)	30.8 (17.0 to 47.6)
Month 66 (n=36)	25.0 (12.1 to 42.2)
Month 72 (n=33)	12.1 (3.4 to 28.2)
Month 78 (n=30)	23.3 (9.9 to 42.3)
Month 84 (n=29)	27.6 (12.7 to 47.2)
Month 90 (n=27)	25.9 (11.1 to 46.3)
Month 96 (n=23)	26.1 (10.2 to 48.4)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Clinically Inactive Disease Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Percentage of Subjects With Clinically Inactive Disease Through Month 96: Withdrawal Period: Extension Study

End point description

Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. The WAS included those subjects who entered the withdrawal period. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 96

End point values	Etanercept
Number of subjects analysed	22
Units: Percentage of subjects
number (confidence interval 95%)
Month 1 (n=22)	54.5 (32.2 to 75.6)
Month 3 (n=15)	66.7 (38.4 to 88.2)
Month 6 (n=12)	66.7 (34.9 to 90.1)
Month 9 (n=11)	81.8 (48.2 to 97.7)
Month 12 (n=10)	80.0 (44.4 to 97.5)
Month 18 (n=10)	80.0 (44.4 to 97.5)
Month 24 (n=8)	87.5 (47.3 to 99.7)
Month 30 (n=7)	71.4 (29.0 to 96.3)
Month 36 (n=6)	83.3 (35.9 to 99.6)
Month 42 (n=6)	50.0 (11.8 to 88.2)
Month 48 (n=4)	50.0 (6.8 to 93.2)
Month 54 (n=3)	66.7 (9.4 to 99.2)
Month 60 (n=3)	100 (29.2 to 100)
Month 66 (n=2)	100 (15.8 to 100)
Month 72 (n=2)	0.0 (0.0 to 84.2)
Month 78 (n=1)	0.0 (0.0 to 97.5)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Clinically Inactive Disease Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Percentage of Subjects With Clinically Inactive Disease Through Month 96: Re-treatment Period: Extension Study

End point description

Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	13
Units: Percentage of subjects
number (confidence interval 95%)
Month 3 (n=13)	23.1 (5.0 to 53.8)
Month 6 (n=13)	46.2 (19.2 to 74.9)
Month 9 (n=12)	33.3 (9.9 to 65.1)
Month 12 (n=11)	45.5 (16.7 to 76.6)
Month 18 (n=10)	50.0 (18.7 to 81.3)
Month 24 (n=8)	62.5 (24.5 to 91.5)
Month 30 (n=9)	33.3 (7.5 to 70.1)
Month 36 (n=9)	55.6 (21.2 to 86.3)
Month 42 (n=7)	28.6 (3.7 to 71.0)
Month 48 (n=6)	16.7 (0.4 to 64.1)
Month 54 (n=6)	33.3 (4.3 to 77.7)
Month 60 (n=5)	40.0 (5.3 to 85.3)
Month 66 (n=4)	50.0 (6.8 to 93.2)
Month 72 (n=3)	33.3 (0.8 to 90.6)
Month 78 (n=2)	50.0 (1.3 to 98.7)

No statistical analyses for this end point

Secondary: Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS) Through Month 96: All Periods: Extension Study

Top of page

End point title

Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS) Through Month 96: All Periods: Extension Study

End point description

JADAS score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). A higher score indicates more disease activity. The analysis set included all subjects enrolled in the extension study. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Etanercept
Number of subjects analysed	80
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=73)	-14.69 ( 7.61 )
Month 6 (n=23)	-15.00 ( 8.08 )
Month 12 (n=57)	-15.09 ( 8.01 )
Month 18 (n=61)	-15.83 ( 9.11 )
Month 24 (n=59)	-15.73 ( 7.84 )
Month 30 (n=57)	-15.54 ( 7.51 )
Month 36 (n=50)	-15.89 ( 7.40 )
Month 42 (n=47)	-16.23 ( 8.42 )
Month 48 (n=46)	-16.65 ( 7.70 )
Month 54 (n=40)	-17.68 ( 8.15 )
Month 60 (n=36)	-17.26 ( 6.90 )
Month 66 (n=34)	-17.19 ( 6.79 )
Month 72 (n=30)	-17.48 ( 6.77 )
Month 78 (n=25)	-17.13 ( 4.66 )
Month 84 (n=26)	-16.68 ( 4.81 )
Month 90 (n=25)	-17.18 ( 4.51 )
Month 96 (n=21)	-16.92 ( 4.75 )

No statistical analyses for this end point

Secondary: Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS) Through Month 96: Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS) Through Month 96: Withdrawal Period: Extension Study

End point description

JADAS score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). A higher score indicates more disease activity. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points. Here, 9999 signifies that mean and standard deviation could not be calculated as there were no participants evaluable.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66

End point values	Etanercept
Number of subjects analysed	24
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n= 24)	-18.24 ( 7.51 )
Month 1 (n=19)	-16.66 ( 8.96 )
Month 3 (n=14)	-17.90 ( 9.04 )
Month 6 (n=10)	-20.41 ( 8.34 )
Month 9 (n=8)	-20.25 ( 9.45 )
Month 12 (n=8)	-20.19 ( 9.36 )
Month 18 (n=8)	-19.44 ( 9.83 )
Month 24 (n=6)	-19.42 ( 9.18 )
Month 30 (n=5)	-16.60 ( 6.32 )
Month 36 (n=4)	-15.50 ( 7.33 )
Month 42 (n=5)	-16.10 ( 6.58 )
Month 48 (n=3)	-17.83 ( 7.18 )
Month 54 (n=2)	-19.25 ( 9.55 )
Month 60 (n=2)	-19.50 ( 9.19 )
Month 66 (n=1)	-26.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS) Through Month 96: Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS) Through Month 96: Re-treatment Period: Extension Study

End point description

JADAS score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). A higher score indicates more disease activity. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points. Data for this endpoint was estimable till Week 78 only.99999 signifies that standard deviation was not estimable as only 1 subject was evaluated.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Etanercept: Re-treatment Period
Number of subjects analysed	13
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=12)	-3.18 ( 9.69 )
Month 3 (n=11)	-13.59 ( 6.06 )
Month 6 (n=13)	-13.80 ( 6.68 )
Month 9 (n=11)	-14.39 ( 7.98 )
Month 12 (n=11)	-13.26 ( 9.31 )
Month 18 (n=10)	-13.51 ( 8.78 )
Month 24 (n=8)	-12.68 ( 8.45 )
Month 30 (n=9)	-12.04 ( 7.89 )
Month 36 (n=9)	-12.90 ( 7.47 )
Month 42 (n=7)	-12.45 ( 9.24 )
Month 48 (n=6)	-10.85 ( 6.66 )
Month 54 (n=6)	-10.85 ( 5.96 )
Month 60 (n=5)	-6.82 ( 4.33 )
Month 66 (n=4)	-8.50 ( 2.12 )
Month 72 (n=3)	-8.17 ( 2.25 )
Month 78 (n=1)	-10.50 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Overall Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): All Periods: Extension Study

Top of page

End point title

Change From Baseline in Overall Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): All Periods: Extension Study

End point description

Overall back pain assessed by subject's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Enthesitis-Related Arthritis
Number of subjects analysed	26
Units: millimeter (mm)
arithmetic mean (standard deviation)
Baseline (n=26)	-16.99 ( 22.80 )
Month 12 (n=21)	-19.88 ( 27.66 )
Month 18 (n=25)	-21.66 ( 28.26 )
Month 24 (n=22)	-20.34 ( 30.98 )
Month 30 (n=20)	-20.08 ( 31.57 )
Month 36 (n=20)	-21.50 ( 28.70 )
Month 42 (n=19)	-21.69 ( 31.79 )
Month 48 (n=18)	-20.37 ( 34.06 )
Month 54 (n=14)	-20.98 ( 34.18 )
Month 60 (n=12)	-20.14 ( 25.00 )
Month 66 (n=11)	-18.15 ( 26.87 )
Month 72 (n=11)	-18.52 ( 24.80 )
Month 78 (n=10)	-16.07 ( 27.50 )
Month 84 (n=10)	-17.07 ( 28.19 )
Month 90 (n=10)	-17.57 ( 29.17 )
Month 96 (n=8)	-20.84 ( 30.08 )

No statistical analyses for this end point

Secondary: Change From Baseline in Overall Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Overall Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Withdrawal Period: Extension Study

End point description

Overall back pain assessed by subject's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points. Data for this endpoint was estimable till Week 42 only.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42

End point values	Enthesitis-Related Arthritis
Number of subjects analysed	8
Units: mm
arithmetic mean (standard deviation)
Baseline (n=8)	-15.88 ( 25.35 )
Month 1 (n=7)	-18.13 ( 26.75 )
Month 3 (n=4)	-27.48 ( 33.22 )
Month 6 (n=3)	-35.21 ( 33.07 )
Month 9 (n=2)	-30.50 ( 51.62 )
Month 12 (n=2)	-32.00 ( 49.50 )
Month 18 (n=2)	-33.50 ( 47.38 )
Month 24 (n=2)	-33.50 ( 47.38 )
Month 30 (n=2)	-14.00 ( 74.95 )
Month 36 (n=2)	-29.00 ( 53.74 )
Month 42 (n=2)	-34.00 ( 46.67 )

No statistical analyses for this end point

Secondary: Change From Baseline in Overall Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Overall Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Re-treatment Period: Extension Study

End point description

Overall back pain assessed by subject's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points. Data for this endpoint was estimable till Week 60 only. 99999 signifies that standard deviation was not estimable as only 1 subject was evaluated.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60

End point values	Enthesitis-Related Arthritis
Number of subjects analysed	2
Units: mm
arithmetic mean (standard deviation)
Baseline (n=1)	-16.00 ( 99999 )
Month 3 (n=2)	-21.00 ( 7.07 )
Month 6 (n=2)	-29.00 ( 18.38 )
Month 9 (n=2)	-24.50 ( 12.02 )
Month 12 (n=2)	-23.50 ( 10.61 )
Month 18 (n=1)	-31.00 ( 99999 )
Month 30 (n=1)	-13.00 ( 99999 )
Month 36 (n=1)	-22.00 ( 99999 )
Month 42 (n=1)	-26.00 ( 99999 )
Month 46 (n=1)	-21.00 ( 99999 )
Month 54 (n=1)	-26.00 ( 99999 )
Month 60 (n=1)	-14.00 ( 99999 )

No statistical analyses for this end point

Secondary: Change From Baseline in Nocturnal Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): All Periods: Extension Study

Top of page

End point title

Change From Baseline in Nocturnal Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): All Periods: Extension Study

End point description

Nocturnal back pain assessed by subject's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain. The analysis set included all subjects enrolled in the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Enthesitis-Related Arthritis
Number of subjects analysed	26
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=26)	-8.84 ( 21.37 )
Month 12 (n=21)	-17.41 ( 29.79 )
Month 18 (n=25)	-14.99 ( 28.13 )
Month 24 (n=22)	-16.90 ( 29.53 )
Month 30 (n=20)	-18.09 ( 31.21 )
Month 36 (n=20)	-17.31 ( 29.73 )
Month 42 (n=19)	-19.23 ( 30.56 )
Month 48 (n=18)	-19.16 ( 31.13 )
Month 54 (n=14)	-23.78 ( 33.66 )
Month 60 (n=12)	-19.83 ( 30.43 )
Month 66 (n=11)	-19.99 ( 29.90 )
Month 72 (n=11)	-16.45 ( 29.24 )
Month 78 (n=10)	-15.89 ( 30.10 )
Month 84 (n=10)	-18.49 ( 34.10 )
Month 90 (n=10)	-17.39 ( 37.42 )
Month 96 (n=8)	-22.49 ( 37.77 )

No statistical analyses for this end point

Secondary: Change From Baseline in Nocturnal Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Withdrawal Period: Extension Study

Top of page

End point title

Change From Baseline in Nocturnal Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Withdrawal Period: Extension Study

End point description

Nocturnal back pain assessed by subject's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain. The WAS included those subjects who entered the withdrawal period. Only data collected in the withdrawal period was included. Here, “n” signifies subjects evaluable at specific time points. Data for this endpoint was estimable till Week 42 only.

End point type

Secondary

End point timeframe

Baseline, Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42

End point values	Enthesitis-Related Arthritis
Number of subjects analysed	8
Units: mm
arithmetic mean (standard deviation)
Baseline (n=8)	-1.38 ( 3.16 )
Month 1 (n=7)	-1.28 ( 3.45 )
Month 3 (n=4)	0.02 ( 0.03 )
Month 6 (n=3)	0.04 ( 1.06 )
Month 9 (n=2)	0.50 ( 0.71 )
Month 12 (n=2)	-0.50 ( 0.71 )
Month 18 (n=2)	0.00 ( 0.00 )
Month 24 (n=2)	0.00 ( 0.00 )
Month 30 (n=2)	11.50 ( 16.26 )
Month 36 (n=2)	0.00 ( 0.00 )
Month 42 (n=2)	0.00 ( 0.00 )

No statistical analyses for this end point

Secondary: Change From Baseline in Nocturnal Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Re-treatment Period: Extension Study

Top of page

End point title

Change From Baseline in Nocturnal Back Pain Through Month 96: Enthesitis-Related Arthritis (ERA): Re-treatment Period: Extension Study

End point description

Nocturnal back pain assessed by subject's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain. The RTAS included those subjects who entered the re-treatment period. Only data collected in the re-treatment period was included. Here, “n” signifies subjects evaluable at specific time points. Data for this endpoint was estimable till Week 60 only.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60

End point values	Enthesitis-Related Arthritis
Number of subjects analysed	2
Units: mm
arithmetic mean (standard deviation)
Baseline (n=1)	-9.00 ( 99999 )
Month 3 (n=2)	-3.00 ( 8.49 )
Month 6 (n=2)	-6.00 ( 4.24 )
Month 9 (n=2)	-0.50 ( 12.02 )
Month 12 (n=2)	0.00 ( 12.73 )
Month 18 (n=1)	4.00 ( 99999 )
Month 30 (n=1)	14.00 ( 99999 )
Month 36 (n=1)	17.00 ( 99999 )
Month 42 (n=1)	7.00 ( 99999 )
Month 48 (n=1)	10.00 ( 99999 )
Month 54 (n=1)	5.00 ( 99999 )
Month 60 (n=1)	38.00 ( 99999 )

No statistical analyses for this end point

Secondary: Bath Ankylosing Spondylitis Metrology Index (BASMI) Score Through Month 96: Enthesitis-Related Arthritis (ERA): All Periods: Extension Study

Top of page

End point title

Bath Ankylosing Spondylitis Metrology Index (BASMI) Score Through Month 96: Enthesitis-Related Arthritis (ERA): All Periods: Extension Study

End point description

Bath Ankylosing Spondylitis Metrology Index (BASMI) is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10. The analysis set included all subjects enrolled in extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Enthesitis-Related Arthritis
Number of subjects analysed	24
Units: Units on scale
arithmetic mean (standard deviation)
Month 12 (n=20)	0.39 ( 0.64 )
Month 18 (n=24)	0.21 ( 0.51 )
Month 24 (n=22)	0.23 ( 0.53 )
Month 30 (n=20)	0.40 ( 0.68 )
Month 36 (n=20)	0.30 ( 0.66 )
Month 42 (n=18)	0.17 ( 0.51 )
Month 48 (n=18)	0.28 ( 0.67 )
Month 54 (n=14)	0.21 ( 0.58 )
Month 60 (n=12)	0.17 ( 0.39 )
Month 66 (n=11)	0.09 ( 0.30 )
Month 72 (n=11)	0.09 ( 0.30 )
Month 78 (n=10)	0.10 ( 0.32 )
Month 84 (n=10)	0.10 ( 0.32 )
Month 90 (n=10)	0.10 ( 0.32 )
Month 96 (n=8)	0.00 ( 0.00 )

No statistical analyses for this end point

Secondary: Change From Baseline in Percentage Body Surface Area Through Month 96: Psoriatic Arthritis (PsA): All Periods: Extension Study

Top of page

End point title

Change From Baseline in Percentage Body Surface Area Through Month 96: Psoriatic Arthritis (PsA): All Periods: Extension Study

End point description

Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the subject's palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. The FAS for active treatment period included all subjects in the parent study who received at least one dose of investigational product regardless of whether they received any investigational product during the extension study. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78

End point values	Psoriatic Arthritis (PsA)
Number of subjects analysed	19
Units: Percentage of body surface area
arithmetic mean (standard deviation)
Baseline (n=19)	-7.74 ( 12.52 )
Month 6 (n=10)	-5.45 ( 10.36 )
Month 12 (n=15)	-10.07 ( 13.96 )
Month 18 (n=15)	-9.82 ( 12.55 )
Month 24 (n=13)	-11.85 ( 13.71 )
Month 30 (n=14)	-10.95 ( 14.42 )
Month 36 (n=13)	-10.38 ( 15.93 )
Month 42 (n=14)	-11.18 ( 14.21 )
Month 48 (n=12)	-11.81 ( 14.06 )
Month 54 (n=11)	-12.45 ( 14.34 )
Month 60 (n=11)	-12.09 ( 13.66 )
Month 66 (n=10)	-10.88 ( 13.38 )
Month 72 (n=9)	-8.88 ( 19.95 )
Month 78 (n=8)	-13.39 ( 14.64 )
Month 84 (n=8)	-13.50 ( 14.93 )
Month 90 (n=6)	-16.83 ( 15.83 )
Month 96 (n=5)	-15.80 ( 17.47 )

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment (PGA) of Psoriasis Score Through Month 96: Psoriatic Arthritis (PsA): All Periods: Extension Study

Top of page

End point title

Change From Baseline in Physician's Global Assessment (PGA) of Psoriasis Score Through Month 96: Psoriatic Arthritis (PsA): All Periods: Extension Study

End point description

PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1. The analysis set included all subjects enrolled in the extension study.

End point type

Secondary

End point timeframe

Baseline, Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96

End point values	Psoriatic Arthritis (PsA)
Number of subjects analysed	19
Units: Units on scale
arithmetic mean (standard deviation)
Baseline (n=19)	-1.16 ( 1.26 )
Month 6 (n=9)	-1.33 ( 1.41 )
Month 12 (n=15)	-1.33 ( 1.23 )
Month 18 (n=15)	-1.20 ( 1.26 )
Month 24 (n=13)	-1.54 ( 1.27 )
Month 30 (n=14)	-1.07 ( 1.49 )
Month 36 (n=14)	-1.21 ( 1.12 )
Month 42 (n=14)	-1.50 ( 1.22 )
Month 48 (n=12)	-1.42 ( 1.08 )
Month 54 (n=11)	-1.18 ( 1.33 )
Month 60 (n=11)	-1.18 ( 1.17 )
Month 66 (n=10)	-1.20 ( 0.92 )
Month 72 (n=9)	-1.11 ( 1.05 )
Month 78 (n=8)	-1.13 ( 1.13 )
Month 84 (n=8)	-1.50 ( 1.07 )
Month 90 (n=6)	-1.50 ( 1.05 )
Month 96 (n=5)	-1.80 ( 1.10 )

No statistical analyses for this end point

Secondary: All Cause Mortality: All Periods: Extension Study

Top of page

End point title

All Cause Mortality: All Periods: Extension Study

End point description

The considered event was death due to any cause from baseline to the end of the study. The full analysis set for extension study included all subjects enrolled in the extension study.

End point type

Secondary

End point timeframe

Baseline upto Month 96

End point values	Etanercept
Number of subjects analysed	109
Units: Subjects	0

No statistical analyses for this end point

Secondary: Number of Subjects With Prior Non-study Medication: All Periods: Extension Study

Top of page

End point title

Number of Subjects With Prior Non-study Medication: All Periods: Extension Study

End point description

Prior non-study medications were defined as any non-study medications taken before the first dose of investigational product taken at the start of the study. The analysis set included all subjects enrolled in extension study.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	Etanercept
Number of subjects analysed	109
Units: Subjects
Anti-infective	2
Corticosteroids	5
Oral corticosteroids	5
Parenteral corticosteroid	99999
Disease-modifying antirheumatic drugs	57
Oral Non-steroidal anti-inflammatory medication	13

No statistical analyses for this end point

Secondary: Number of Subjects With Concomitant Non-study Medication: All Periods: Extension Study

Top of page

End point title

Number of Subjects With Concomitant Non-study Medication: All Periods: Extension Study

End point description

Concomitant non-study medications were defined as any non-study medications taken during the treatment period. The analysis set included all subjects enrolled the extension study.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	Etanercept
Number of subjects analysed	109
Units: Subjects
Anti-infective medications	62
Corticosteroids	29
Oral corticosteroids	16
Parenteral corticosteroid	12
Disease-modifying antirheumatic drugs	64
Non-steroidal anti-inflammatory drugs	51
Oral Non-steroidal anti-inflammatory drugs	48

No statistical analyses for this end point

Secondary: Number of Subjects With After Non-study Medication: All Periods: Extension Study

Top of page

End point title

Number of Subjects With After Non-study Medication: All Periods: Extension Study

End point description

After non-study medications referred to any non-study medications taken after the last dose of the investigational product. The analysis set included all subjects enrolled in the extension study.

End point type

Secondary

End point timeframe

Baseline up to Month 96

End point values	Etanercept
Number of subjects analysed	109
Units: Subjects
Anti-infectives	7
Corticosteroids	6
Oral corticosteroids	3
Parenteral corticosteroid	1
Disease-modifying antirheumatic drugs	48
Non-steroidal anti-inflammatory drugs	16
Oral Non-steroidal anti-inflammatory drugs	16

No statistical analyses for this end point

Secondary: Exposure Time: All Periods: Extension Study

Top of page

End point title

Exposure Time: All Periods: Extension Study

End point description

The exposure time (years) to etanercept was calculated for each subject each period using (the last dose date – the first dose date + 1)/365.25. If the gap was less than 28 days between two etanercept treatment periods, the cumulative exposure included the gap. Else, the gap was excluded from the cumulative exposure. The analysis set included all subjects enrolled in the extension study.

End point type

Secondary

End point timeframe

First dose to the last dose

End point values	Etanercept
Number of subjects analysed	99
Units: Years
arithmetic mean (standard deviation)	244.79 ( 147.71 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Total CHAQ Score Improvement of >0.188 From Baseline of 1014:All Periods: Extension Study

Top of page

End point title

Percentage of Participants With Total CHAQ Score Improvement of >0.188 From Baseline of 1014:All Periods: Extension Study

End point description

Childhood Health Assessment Questionnaire (CHAQ): parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subject's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain. Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. Here, “n” signifies subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline of parent study through Month 96

End point values	Etanercept
Number of subjects analysed	80
Units: Percentage of Subjects
number (confidence interval 95%)
Baseline (n=80)	68.8 (57.4 to 78.7)
Month 6 (n=74)	73.0 (61.4 to 82.6)
Month 12 (n=62)	79.0 (66.8 to 88.3)
Month 18 (n=46)	78.3 (63.6 to 89.1)
Month 24 (n=37)	86.5 (71.2 to 95.5)
Month 30 (n=32)	90.6 (75.0 to 98.0)
Month 36 (n=22)	90.9 (70.8 to 98.9)
Month 42 (n=21)	95.2 (76.2 to 99.9)
Month 48 (n=16)	93.8 (69.8 to 99.8)
Month 54 (n=10)	100.0 (69.2 to 100.0)
Month 60 (n=8)	100.0 (63.1 to 100.0)
Month 66 (n=7)	100.0 (59.0 to 100.0)
Month 72 (n=6)	100.0 (54.1 to 100.0)
Month 78 (n=5)	100.0 (47.8 to 100.0)
Month 84 (n=4)	100.0 (39.8 to 100.0)
Month 90 (n=4)	100.0 (39.8 to 100.0)
Month 96 (n=2)	100.0 (15.8 to 100.0)

No statistical analyses for this end point

Secondary: Number of Subjects With Vital Signs Abnormalities: All Periods: Parent and Extension Study

Top of page

End point title

Number of Subjects With Vital Signs Abnormalities: All Periods: Parent and Extension Study

End point description

Vital signs assessment included temperature, pulse, systolic and diastolic blood pressure. Pulse rate was obtained with subject in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion. The FAS included all subjects in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.

End point type

Secondary

End point timeframe

Baseline up to 96 months

End point values	All Periods (Parent and Extension Study)
Number of subjects analysed	99
Units: Subjects
Pulse (low)	1
Systolic blood pressure (high)	14
Diastolic blood pressure (low)	4
Diastolic blood pressure (high)	2

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Screening up to Month 96

Adverse event reporting additional description

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study. AEs and SAEs were analysed for full analysis set.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

v23.1

Reporting group title

Etanercept

Reporting group description

Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 months.

Serious adverse events	Etanercept
Total subjects affected by serious adverse events
subjects affected / exposed	22 / 109 (20.18%)
number of deaths (all causes)	0
number of deaths resulting from adverse events	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Vascular disorders
Varicose vein
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Surgical and medical procedures
Knee operation
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Reproductive system and breast disorders
Varicocele
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Psychiatric disorders
Attention deficit hyperactivity disorder
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Depression
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Suicide attempt
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Fractured coccyx
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Facial bones fracture
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Meniscus injury
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Multiple fractures
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Radius fracture
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Nervous system disorders
Psychomotor hyperactivity
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Eye disorders
Iridocyclitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Uveitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Crohn's disease
subjects affected / exposed	2 / 109 (1.83%)
occurrences causally related to treatment / all	1 / 2
deaths causally related to treatment / all	0 / 0
Intestinal perforation
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal and urinary disorders
Renal colic
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Synovitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Appendicitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Dengue fever
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Influenza
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Sepsis
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	1 / 1
deaths causally related to treatment / all	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 109 (0.92%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 1%

Non-serious adverse events	Etanercept
Total subjects affected by non serious adverse events
subjects affected / exposed	85 / 109 (77.98%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Uterine leiomyoma
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Vascular disorders
Haematoma
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Surgical and medical procedures
Wisdom teeth removal
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Tonsillectomy
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	6 / 109 (5.50%)
occurrences all number	9
Injection site reaction
subjects affected / exposed	6 / 109 (5.50%)
occurrences all number	7
Chest pain
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Peripheral swelling
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Influenza like illness
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	5
Immune system disorders
Hypersensitivity
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Vaginal discharge
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Ovarian cyst
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Epistaxis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Cough
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Catarrh
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Rhinitis allergic
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Tonsillar hypertrophy
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Oropharyngeal pain
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Psychiatric disorders
Depression
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Investigations
Blood pressure increased
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	2
Aspartate aminotransferase abnormal
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Alanine aminotransferase increased
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Intraocular pressure increased
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Transaminases increased
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
White blood cell count decreased
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	3
Weight increased
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Injury, poisoning and procedural complications
Animal bite
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Chillblains
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Contusion
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Facial bones fracture
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Fibula fracture
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Foot fracture
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Hand fracture
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Head injury
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Joint dislocation
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Joint injury
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Ligament sprain
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	7
Limb injury
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Post-traumatic neck syndrome
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Radius fracture
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	4
Skin laceration
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	2
Patella fracture
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Scar
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Skeletal injury
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Skin abrasion
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Nervous system disorders
Headache
subjects affected / exposed	5 / 109 (4.59%)
occurrences all number	5
Dizziness
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Sciatica
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Migraine
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Syncope
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Narcolepsy
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Iron deficiency anaemia
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Lymphadenitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Neutropenia
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Thrombocytopenia
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Leukopenia
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Ear and labyrinth disorders
Tympanic membrane disorder
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Eustachian tube disorder
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Vertigo
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Tympanic membrane perforation
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Eye disorders
Iridocyclitis
subjects affected / exposed	5 / 109 (4.59%)
occurrences all number	5
Maculopathy
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Scleral haemorrhage
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Uveitis
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Abdominal pain upper
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Anal fistula
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Aphthous ulcer
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Colitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Constipation
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Diarrhoea
subjects affected / exposed	6 / 109 (5.50%)
occurrences all number	6
Dyspepsia
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Enteritis
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Food poisoning
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Gastritis
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Nausea
subjects affected / exposed	5 / 109 (4.59%)
occurrences all number	5
Pneumoperitoneum
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Toothache
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Vomiting
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Enterocolitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Hepatobiliary disorders
Hypertransaminasaemia
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Acne conglobata
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Dermatitis atopic
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Acne cystic
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Hair colour changes
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Rash
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Psoriasis
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Rash erythematous
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Skin lesion
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Photosensitivity reaction
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Renal and urinary disorders
Renal colic
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Haematuria
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	11 / 109 (10.09%)
occurrences all number	16
Arthritis
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Back pain
subjects affected / exposed	7 / 109 (6.42%)
occurrences all number	7
Bone pain
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Bone swelling
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Haematoma muscle
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Groin pain
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Intervertebral disc disorder
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Joint effusion
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	5
Intervertebral disc protrusion
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Juvenile idiopathic arthritis
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Joint swelling
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Joint laxity
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Muscle contracture
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Myalgia
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Pain in jaw
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Pain in extremity
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Osteonecrosis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Tendonitis
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Spinal pain
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Neck pain
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Tenosynovitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Plantar fasciitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Synovitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Infections and infestations
Acarodermatitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Conjunctivitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Anal abscess
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Acute sinusitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Cystitis
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Diarrhoea infectious
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Bronchitis
subjects affected / exposed	12 / 109 (11.01%)
occurrences all number	14
Ear infection
subjects affected / exposed	5 / 109 (4.59%)
occurrences all number	10
Gastrointestinal viral infection
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Folliculitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Enterovirus infection
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Gingivitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Infectious mononucleosis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Influenza
subjects affected / exposed	8 / 109 (7.34%)
occurrences all number	11
Laryngitis
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Nasopharyngitis
subjects affected / exposed	8 / 109 (7.34%)
occurrences all number	9
Oral herpes
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	11
Orchitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Otitis externa
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Otitis media
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Otitis media acute
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Paronychia
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Periodontitis
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Pertussis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Pharyngitis
subjects affected / exposed	21 / 109 (19.27%)
occurrences all number	54
Pharyngotonsillitis
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Pneumonia
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Pulpitis dental
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Respiratory tract infection
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Respiratory tract infection viral
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	3
Sinusitis
subjects affected / exposed	8 / 109 (7.34%)
occurrences all number	8
Septic shock
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Suspected COVID-19
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Staphylococcal skin infection
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	6
Tinea versicolour
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Tonsillitis
subjects affected / exposed	9 / 109 (8.26%)
occurrences all number	17
Vaginal infection
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Urinary tract infection
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Upper respiratory tract infection
subjects affected / exposed	28 / 109 (25.69%)
occurrences all number	85
Varicella
subjects affected / exposed	3 / 109 (2.75%)
occurrences all number	3
Viraemia
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Viral infection
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	4
Wound infection
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Viral upper respiratory tract infection
subjects affected / exposed	2 / 109 (1.83%)
occurrences all number	2
Viral tonsillitis
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Gastroenteritis
subjects affected / exposed	10 / 109 (9.17%)
occurrences all number	10
Gastroenteritis viral
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Herpes simplex
subjects affected / exposed	1 / 109 (0.92%)
occurrences all number	1
Rhinitis
subjects affected / exposed	4 / 109 (3.67%)
occurrences all number	5

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

20 Jul 2012

Changes in study title, schedule of activities and study objectives.

09 Mar 2015

Modification in adverse event reporting section and communication of results by Pfizer.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The data for endpoint analysis taken from statistical analysis plan based on the study team discretion.

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects With Malignancy: All Periods: Parent and Extension Study

Primary: Number of Subjects With Malignancy: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Serious Adverse Events: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Serious Adverse Events: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Serious Infections: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Serious Infections: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Medically Important Infections: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Medically Important Infections: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Infections: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Infections: All Periods: Parent and Extension Study

Secondary: Number of Subjects With Infections and Injection Site Reactions: All Periods: Extension Study

Secondary: Number of Subjects With Infections and Injection Site Reactions: All Periods: Extension Study

Secondary: Number of Subjects With Infections: Withdrawal Period: Extension Study

Secondary: Number of Subjects With Infections: Withdrawal Period: Extension Study

Secondary: Number of Subjects Withdrawn Due to Adverse Events: All Periods: Parent and Extension Study

Secondary: Number of Subjects Withdrawn Due to Adverse Events: All Periods: Parent and Extension Study

Secondary: Number of Subjects Withdrawn Due to Adverse Events: Withdrawal Period: Extension Study

Secondary: Number of Subjects Withdrawn Due to Adverse Events: Withdrawal Period: Extension Study

Secondary: Number of Subjects With Grade 3 or Grade 4 Laboratory Abnormalities: All Periods: Extension Study

Secondary: Number of Subjects With Grade 3 or Grade 4 Laboratory Abnormalities: All Periods: Extension Study

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 48, 60, 72, 84, 96: All Periods: Extension Study

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 48, 60, 72, 84, 96: All Periods: Extension Study

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72: Withdrawal Period: Extension Study

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72: Withdrawal Period: Extension Study

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60: Re-treatment Period: Extension Study

Secondary: Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60: Re-treatment Period: Extension Study

Secondary: Change from Baseline in Tanner Assessment Score for Subjects Aged <18 Years at Month 96: All Periods: Extension Study

Secondary: Change from Baseline in Tanner Assessment Score for Subjects Aged <18 Years at Month 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 30% (ACR30) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 90% (ACR90) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96: All Periods: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72: Withdrawal Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Percentage of Subjects Achieving American College of Rheumatology 100% (ACR100) Pediatric Response at Month 3, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78: Re-treatment Period: Extension Study

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: All Periods: Extension Study

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: All Periods: Extension Study

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Withdrawal Period: Extension Study

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Withdrawal Period: Extension Study

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Re-treatment Period: Extension Study

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity Score Through Month 96: Re-treatment Period: Extension Study

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: All Periods: Extension Study

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: All Periods: Extension Study

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Withdrawal Period: Extension Study

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Withdrawal Period: Extension Study

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Re-treatment Period: Extension Study

Secondary: Change From Baseline in Patient/Parent Global Assessment Score Through Month 96: Re-treatment Period: Extension Study

Secondary: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Score for Subjects Through Month 96: All Periods: Extension Study