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Clinical Trial Results:
Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)

Summary
EudraCT number	2009-013091-40
Trial protocol	FR DE SE SK CZ DK Outside EU/EEA
Global end of trial date	21 Mar 2013

Results information
Results version number	v2(current)
This version publication date	18 May 2016
First version publication date	22 Jul 2015
Other versions	v1 (removed from public view)
Version creation reason	Correction of full data set Potential category issues

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

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Trial information

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Sponsor protocol code

M10-444

ISRCTN number

US NCT number

NCT00775437

WHO universal trial number (UTN)

Sponsor organisation name

AbbVie

Sponsor organisation address

1 North Waukegan Road, North Chicago, IL, United States, 60064

Public contact

Global Medical Information, AbbVie, 001 800-633-9110,

Scientific contact

Aileen L. Pangan MD, AbbVie, aileen.pangan@abbvie.com

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

Yes

EMA paediatric investigation plan number(s)

EMEA-000036-PIP01-08

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?

Analysis stage

Final

Date of interim/final analysis

21 Mar 2013

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Mar 2013

Was the trial ended prematurely?

Main objective of the trial

The main objective of this study is to evaluate the safety of adalimumab in patients 2 to < 4 years of age or ≥ 4 years of age weighing < 15 kg, with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.

Protection of trial subjects

Parent or legal guardian read and understood the information provided about the study and gave written permission. An assent form was not used in this study due to the young age of children being studied.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Mar 2009

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 15

Country: Number of subjects enrolled

Czech Republic: 9

Country: Number of subjects enrolled

France: 4

Country: Number of subjects enrolled

Germany: 4

Worldwide total number of subjects

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

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Recruitment details

Subjects were enrolled at 14 investigative sites in the Czech Republic, France, Germany, and the United States.

Screening details

Subjects age 2 to < 4 years or ≥ 4 years and under 15 kg with moderately to severely active polyarticular or polyarticular-course JIA with a parent/guardian to administer injections. The screening visit occurred between Day -28 and Day 0.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Adalimumab

Arm description

Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Subjects could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those subjects who continued in the study.

Arm type

Experimental

Investigational medicinal product name

Adalimumab

Investigational medicinal product code

Other name

Humira, ABT-D2E7

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Adalimumab administered by parent or designee as a single dose via subcutaneous injection at approximately the same time of day

Number of subjects in period 1	Adalimumab
Started	32
Completed	26
Not completed	6
Consent withdrawn by subject	3
Loss of efficacy	2
Lost to follow-up	1

Baseline characteristics

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Reporting group title

Adalimumab

Reporting group description

Reporting group values	Adalimumab	Total
Number of subjects	32	32
Age categorical
Units: Subjects
< 4 years	28	28
≥ 4 years	4	4
Age continuous
Units: years
arithmetic mean (standard deviation)	3.04 ( 0.723 )	-
Gender categorical
Units: Subjects
Female	28	28
Male	4	4
Weight
Units: kilogram(s)
arithmetic mean (standard deviation)	13.4 ( 1.96 )	-

End points

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Reporting group title

Adalimumab

Reporting group description

Primary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

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End point title

Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) ^[1]

End point description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an AE meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent a serious outcome. A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a subject from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration (total of 32.5 months).

End point type

Primary

End point timeframe

TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months).

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: Descriptive data were summarized for this endpoint per protocol.

End point values	Adalimumab
Number of subjects analysed	32
Units: Subjects
Any Treatment-emergent AE	29
Any Treatment-emergent SAE	5

No statistical analyses for this end point

Secondary: Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24

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End point title

Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24

End point description

Adalimumab concentrations in serum were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method. The lower limit of quantitation (LLOQ) for adalimumab is 3.13 ng/mL.

End point type

Secondary

End point timeframe

Weeks 0, 12, and 24

End point values	Adalimumab
Number of subjects analysed	15 ^[2]
Units: µg/mL
arithmetic mean (standard deviation)
Week 0	0 ( 0 )
Week 12	6.97 ( 5.69 )
Week 24	7.78 ( 5.85 )

Notes
[2] - All subjects who had samples for pharmacokinetic analysis

No statistical analyses for this end point

Secondary: Hemoglobin: Mean Change From Baseline to Each Visit

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End point title

Hemoglobin: Mean Change From Baseline to Each Visit

End point description

Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: g/L
arithmetic mean (standard deviation)
Week 12 (n=29)	6.7 ( 7.32 )
Week 24 (n=29)	6.7 ( 9.76 )
Week 36 (n=25)	5.5 ( 9.31 )
Week 48 (n=24)	5.3 ( 10.68 )
Week 60 (n=21)	6 ( 10.96 )
Week 72 (n=17)	9.5 ( 10.65 )
Week 84 (n=16)	10.5 ( 13.69 )
Week 96 (n=11)	8.6 ( 9.99 )
Week 108 (n=9)	7.7 ( 8.08 )
Week 120 (n=3)	4.7 ( 2.89 )

No statistical analyses for this end point

Secondary: Hematocrit: Mean Change From Baseline to Each Visit

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End point title

Hematocrit: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: Fraction
arithmetic mean (standard deviation)
Week 12 (n=29)	0.018 ( 0.0206 )
Week 24 (n=29)	0.016 ( 0.0289 )
Week 36 (n=25)	0.017 ( 0.0292 )
Week 48 (n=24)	0.011 ( 0.0288 )
Week 60 (n=21)	0.009 ( 0.0275 )
Week 72 (n=17)	0.024 ( 0.0264 )
Week 84 (n=16)	0.026 ( 0.0366 )
Week 96 (n=11)	0.023 ( 0.0319 )
Week 108 (n=9)	0.018 ( 0.0273 )
Week 120 (n=3)	0.008 ( 0.0082 )

No statistical analyses for this end point

Secondary: Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit

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End point title

Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10˄12/L
arithmetic mean (standard deviation)
Week 12 (n=29)	0.15 ( 0.231 )
Week 24 (n=29)	0.08 ( 0.308 )
Week 36 (n=25)	0.098 ( 0.277 )
Week 48 (n=24)	0.05 ( 0.213 )
Week 60 (n=21)	0.07 ( 0.296 )
Week 72 (n=17)	0.1 ( 0.187 )
Week 84 (n=16)	0.06 ( 0.228 )
Week 96 (n=11)	0.08 ( 0.343 )
Week 108 (n=9)	0.1 ( 0.32 )
Week 120 (n=3)	0.03 ( 0.153 )

No statistical analyses for this end point

Secondary: Platelets: Mean Change From Baseline to Each Visit

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End point title

Platelets: Mean Change From Baseline to Each Visit

End point description

Baseline is the last value prior to the first dose of study drug. Baseline is the last value prior to the first dose of study drug. Subjects with non-missing baseline and at least 1 post-baseline observation are included in the analysis. n=subjects with evaluable data at given time point.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10˄9/L
arithmetic mean (standard deviation)
Week 12 (n=29)	-35 ( 145.44 )
Week 24 (n=29)	-57.7 ( 140.82 )
Week 36 (n=25)	-75.2 ( 148.51 )
Week 48 (n=23)	-21 ( 174.17 )
Week 60 (n=21)	-46.7 ( 125.71 )
Week 72 (n=17)	-51.1 ( 111.11 )
Week 84 (n=15)	-58.5 ( 127.29 )
Week 96 (n=11)	-49.2 ( 142.73 )
Week 108 (n=9)	-30.4 ( 137.84 )
Week 120 (n=3)	20 ( 185.95 )

No statistical analyses for this end point

Secondary: White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit

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End point title

White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10^9/L
arithmetic mean (standard deviation)
Week 12 (n=29)	0.19 ( 3.959 )
Week 24 (n=29)	-0.25 ( 3.756 )
Week 36 (n=25)	-0.42 ( 4.632 )
Week 48 (n=24)	0.3 ( 4.804 )
Week 60 (n=21)	0.25 ( 2.183 )
Week 72 (n=17)	0.66 ( 3.225 )
Week 84 (n=16)	0.18 ( 2.944 )
Week 96 (n=11)	0.55 ( 2.757 )
Week 108 (n=9)	-0.76 ( 4.166 )
Week 120 (n=3)	1.8 ( 3.651 )

No statistical analyses for this end point

Secondary: Neutrophils: Mean Change From Baseline to Each Visit

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End point title

Neutrophils: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10˄9/L
arithmetic mean (standard deviation)
Week 12 (n=29)	-0.138 ( 2.9819 )
Week 24 (n=29)	-0.619 ( 3.0082 )
Week 36 (n=25)	-0.586 ( 3.7363 )
Week 48 (n=24)	0.065 ( 3.4433 )
Week 60 (n=21)	0.222 ( 2.0937 )
Week 72 (n=17)	-0.169 ( 2.6167 )
Week 84 (n=16)	-0.206 ( 2.0077 )
Week 96 (n=11)	0.293 ( 2.511 )
Week 108 (n=9)	-0.39 ( 3.1702 )
Week 120 (n=3)	2.47 ( 3.2658 )

No statistical analyses for this end point

Secondary: Lymphocytes: Mean Change From Baseline to Each Visit

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End point title

Lymphocytes: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10˄9/L
arithmetic mean (standard deviation)
Week 12 (n=29)	0.371 ( 2.3523 )
Week 24 (n=29)	0.292 ( 1.9345 )
Week 36 (n=25)	0.176 ( 1.962 )
Week 48 (n=24)	0.186 ( 1.9584 )
Week 60 (n=21)	-0.034 ( 1.6129 )
Week 72 (n=17)	0.636 ( 1.7404 )
Week 84 (n=16)	0.306 ( 1.5143 )
Week 96 (n=11)	0.006 ( 1.9402 )
Week 108 (n=9)	-0.46 ( 2.4315 )
Week 120 (n=3)	-0.67 ( 1.8041 )

No statistical analyses for this end point

Secondary: Monocytes: Mean Change From Baseline to Each Visit

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End point title

Monocytes: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10^9/L
arithmetic mean (standard deviation)
Week 12 (n=29)	-0.032 ( 0.3051 )
Week 24 (n=29)	0.081 ( 0.4547 )
Week 36 (n=25)	0.028 ( 0.2978 )
Week 48 (n=24)	-0.006 ( 0.2718 )
Week 60 (n=21)	0.08 ( 0.1831 )
Week 72 (n=17)	0.113 ( 0.2054 )
Week 84 (n=16)	0.061 ( 0.2594 )
Week 96 (n=11)	0.089 ( 0.2295 )
Week 108 (n=9)	0.096 ( 0.3248 )
Week 120 (n=3)	0.057 ( 0.0777 )

No statistical analyses for this end point

Secondary: Eosinophils: Mean Change From Baseline to Each Visit

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End point title

Eosinophils: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10^9/L
arithmetic mean (standard deviation)
Week 12 (n=29)	-0.004 ( 0.1771 )
Week 24 (n=29)	-0.006 ( 0.1545 )
Week 36 (n=25)	-0.052 ( 0.1374 )
Week 48 (n=24)	0.056 ( 0.2773 )
Week 60 (n=21)	-0.015 ( 0.1363 )
Week 72 (n=17)	0.069 ( 0.1886 )
Week 84 (n=16)	0.016 ( 0.1631 )
Week 96 (n=11)	0.158 ( 0.3207 )
Week 108 (n=9)	-0.002 ( 0.0864 )
Week 120 (n=3)	-0.063 ( 0.0929 )

No statistical analyses for this end point

Secondary: Basophils: Mean Change From Baseline to Each Visit

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End point title

Basophils: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	31
Units: x10^9/L
arithmetic mean (standard deviation)
Week 12 (n=29)	-0.012 ( 0.0299 )
Week 24 (n=29)	-0.002 ( 0.0272 )
Week 36 (n=25)	0.003 ( 0.0244 )
Week 48 (n=24)	0.005 ( 0.0412 )
Week 60 (n=21)	-0.003 ( 0.0256 )
Week 72 (n=17)	0.007 ( 0.031 )
Week 84 (n=16)	-0.001 ( 0.0171 )
Week 96 (n=11)	-0.003 ( 0.0205 )
Week 108 (n=9)	-0.001 ( 0.0117 )
Week 120 (n=3)	0.003 ( 0.0306 )

No statistical analyses for this end point

Secondary: Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit

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End point title

Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	30
Units: U/L
arithmetic mean (standard deviation)
Week 12 (n=27)	0.5 ( 9.96 )
Week 24 (n=28)	-1.1 ( 17.13 )
Week 36 (n=25)	0 ( 29.82 )
Week 48 (n=24)	-4.5 ( 24.81 )
Week 60 (n=21)	-2 ( 10.25 )
Week 72 (n=16)	-1.8 ( 10.1 )
Week 84 (n=16)	-0.5 ( 14.56 )
Week 96 (n=11)	-3.9 ( 15.4 )
Week 108 (n=9)	-2.4 ( 6.31 )
Week 120 (n=3)	-14.3 ( 23.12 )

No statistical analyses for this end point

Secondary: Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit

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End point title

Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	30
Units: U/L
arithmetic mean (standard deviation)
Week 12 (n=26)	2.8 ( 7.56 )
Week 24 (n=28)	-0.6 ( 8.82 )
Week 36 (n=25)	2 ( 23.26 )
Week 48 (n=24)	-0.7 ( 16.13 )
Week 60 (n=21)	-0.4 ( 7.63 )
Week 72 (n=16)	0.3 ( 7.36 )
Week 84 (n=16)	-0.4 ( 6.89 )
Week 96 (n=10)	1.5 ( 11.48 )
Week 108 (n=9)	0.4 ( 6.21 )
Week 120 (n=3)	-8.3 ( 11.93 )

No statistical analyses for this end point

Secondary: Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit

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End point title

Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	30
Units: U/L
arithmetic mean (standard deviation)
Week 12 (n=27)	15.7 ( 64.65 )
Week 24 (n=28)	10.6 ( 68.75 )
Week 36 (n=25)	23.2 ( 73.28 )
Week 48 (n=24)	21.7 ( 73.03 )
Week 60 (n=21)	17.9 ( 85.55 )
Week 72 (n=16)	17.9 ( 83.52 )
Week 84 (n=16)	31.5 ( 89.3 )
Week 96 (n=11)	59.4 ( 57.65 )
Week 108 (n=9)	-6.3 ( 100.72 )
Week 120 (n=3)	-72.3 ( 169.19 )

No statistical analyses for this end point

Secondary: Creatine Phosphokinase: Mean Change From Baseline to Each Visit

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End point title

Creatine Phosphokinase: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	30
Units: U/L
arithmetic mean (standard deviation)
Week 12 (n=27)	17.2 ( 50.48 )
Week 24 (n=27)	7 ( 30.79 )
Week 36 (n=25)	24.8 ( 44.5 )
Week 48 (n=24)	18.4 ( 54.02 )
Week 60 (n=21)	26.6 ( 65.48 )
Week 72 (n=16)	41.6 ( 40.63 )
Week 84 (n=16)	36.4 ( 53.64 )
Week 96 (n=11)	28.7 ( 41.79 )
Week 108 (n=9)	7.2 ( 22.97 )
Week 120 (n=3)	14 ( 40.73 )

No statistical analyses for this end point

Secondary: Total Bilirubin: Mean Change From Baseline to Each Visit

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End point title

Total Bilirubin: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	30
Units: µmol/L
arithmetic mean (standard deviation)
Week 12 (n=27)	1.2 ( 2.42 )
Week 24 (n=28)	0.6 ( 1.59 )
Week 36 (n=25)	0.6 ( 1.61 )
Week 48 (n=24)	0.9 ( 2.4 )
Week 60 (n=21)	1 ( 2.09 )
Week 72 (n=16)	0.2 ( 1.25 )
Week 84 (n=16)	0.5 ( 2.36 )
Week 96 (n=11)	0.7 ( 1.62 )
Week 108 (n=9)	1.1 ( 2.71 )
Week 120 (n=3)	2.3 ( 0.58 )

No statistical analyses for this end point

Secondary: Creatinine: Mean Change From Baseline to Each Visit

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End point title

Creatinine: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	30
Units: µmol/L
arithmetic mean (standard deviation)
Week 12 (n=27)	1.7 ( 5.98 )
Week 24 (n=28)	0.5 ( 5.3 )
Week 36 (n=25)	0.3 ( 5.84 )
Week 48 (n=24)	2.5 ( 7.8 )
Week 60 (n=21)	2.8 ( 5.79 )
Week 72 (n=16)	3.4 ( 6.96 )
Week 84 (n=16)	4 ( 6.37 )
Week 96 (n=11)	3.2 ( 5.53 )
Week 108 (n=9)	6.2 ( 6.7 )
Week 120 (n=3)	8.7 ( 5.51 )

No statistical analyses for this end point

Secondary: Uric Acid: Mean Change From Baseline to Each Visit

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End point title

Uric Acid: Mean Change From Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	30
Units: µmol/L
arithmetic mean (standard deviation)
Week 12 (n=27)	1.7 ( 48.24 )
Week 24 (n=27)	6.5 ( 47.93 )
Week 36 (n=25)	2.5 ( 41.77 )
Week 48 (n=24)	5.6 ( 45.62 )
Week 60 (n=21)	1.9 ( 30.86 )
Week 72 (n=16)	-0.9 ( 43.53 )
Week 84 (n=16)	-4.5 ( 46.76 )
Week 96 (n=11)	13.3 ( 36.39 )
Week 108 (n=9)	-10.1 ( 33.55 )
Week 120 (n=3)	-7 ( 27.78 )

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 30% Response (PedACR30)

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End point title

Percentage of Subjects Achieving Pediatric American College of Rheumatology 30% Response (PedACR30)

End point description

The PedACR30 response is defined by the Pediatric American College of Rheumatology as ≥30% improvement in ≥3 of 6 JIA core set criteria, and ≥30% worsening in ≤1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria are Physician's Global Assessment (PGA) of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with loss of passive motion [LOM] and joints with pain on passive motion [POM], tenderness, or both), number of joints with LOM, Disability Index of Child Health Assessment Questionnaire (DICHAQ), and C-reactive protein (CRP). Baseline=last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using last observation carried forward (LOCF) and non-responder imputation (NRI); observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: percentage of subjects
number (not applicable)
Week 12 Observed (n=31)	93.5
Week 12 NRI (n=32)	90.6
Week 12 LOCF (n=31)	93.5
Week 24 Observed (n=30)	90
Week 24 NRI (n=32)	84.4
Week 24 LOCF (n=31)	90.3
Week 36 Observed (n=27)	92.6
Week 36 NRI (n=32)	78.1
Week 36 LOCF (n=31)	93.5
Week 48 Observed (n=24)	83.3
Week 48 NRI (n=32)	62.5
Week 48 LOCF (n=31)	83.9
Week 60 Observed (n=20)	90
Week 60 NRI (n=32)	56.3
Week 60 LOCF (n=31)	87.1
Week 72 Observed (n=17)	100
Week 84 Observed (n=17)	100
Week 96 Observed (n=13)	92.3
Week 108 Observed (n=9)	88.9
Week 120 Observed (n=3)	100

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 50% Response (PedACR50)

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End point title

Percentage of Subjects Achieving Pediatric American College of Rheumatology 50% Response (PedACR50)

End point description

The PedACR50 response is defined by the Pediatric American College of Rheumatology as ≥ 50% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: percentage of subjects
number (not applicable)
Week 12 Observed (n=31)	90.3
Week 12 NRI (n=32)	87.5
Week 12 LOCF (n=31)	90.3
Week 24 Observed (n=30)	83.3
Week 24 NRI (n=32)	78.1
Week 24 LOCF (n=31)	83.9
Week 36 Observed (n=27)	88.9
Week 36 NRI (n=32)	75
Week 36 LOCF (n=31)	90.3
Week 48 Observed (n=24)	79.2
Week 48 NRI (n=32)	59.4
Week 48 LOCF (n=31)	80.6
Week 60 Observed (n=20)	80
Week 60 NRI (n=32)	50
Week 60 LOCF (n=31)	80.6
Week 72 Observed (n=17)	100
Week 84 Observed (n=17)	94.1
Week 96 Observed (n=13)	92.3
Week 108 Observed (n=9)	88.9
Week 120 Observed (n=3)	100

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 70% Response (PedACR70)

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End point title

Percentage of Subjects Achieving Pediatric American College of Rheumatology 70% Response (PedACR70)

End point description

The PedACR70 response is defined by the Pediatric American College of Rheumatology as ≥ 70% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: percentage of subjects
number (not applicable)
Week 12 Observed (n=31)	61.3
Week 12 NRI (n=32)	59.4
Week 12 LOCF (n=31)	61.3
Week 24 Observed (n=30)	73.3
Week 24 NRI (n=32)	68.8
Week 24 LOCF (n=31)	74.2
Week 36 Observed (n=27)	66.7
Week 36 NRI (n=32)	56.3
Week 36 LOCF (n=31)	67.7
Week 48 Observed (n=24)	75
Week 48 NRI (n=32)	56.3
Week 48 LOCF (n=31)	74.2
Week 60 Observed (n=20)	70
Week 60 NRI (n=32)	43.8
Week 60 LOCF (n=31)	71
Week 72 Observed (n=17)	76.5
Week 84 Observed (n=17)	82.4
Week 96 Observed (n=13)	76.9
Week 108 Observed (n=9)	77.8
Week 120 Observed (n=3)	100

No statistical analyses for this end point

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 90% Response (PedACR90)

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End point title

Percentage of Subjects Achieving Pediatric American College of Rheumatology 90% Response (PedACR90)

End point description

The PedACR90 response is defined by the Pediatric American College of Rheumatology as ≥ 90% improvement in at least 3 of 6 JIA core set criteria, and ≥ 30% worsening in not more than 1 of 6 JIA core set criteria. The 6 variables for the JIA core set criteria include PGA of subject's disease activity, Parent's Global Assessment of subject's disease activity, number of active joints (joints with swelling not due to deformity or joints with LOM and joints with POM, tenderness, or both), number of joints with LOM, DICHAQ, and CRP. Baseline is the last value prior to the first dose of study drug. Missing data were imputed up to Week 60 using LOCF and by NRI; observed values are presented for timepoints past Week 60. n=number of subjects for either observed or imputed methods at given time point.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: percentage of subjects
number (not applicable)
Week 12 Observed (n=31)	38.7
Week 12 NRI (n=32)	37.5
Week 12 LOCF (n=31)	38.7
Week 24 Observed (n=30)	36.7
Week 24 NRI (n=32)	34.4
Week 24 LOCF (n=31)	35.5
Week 36 Observed (n=27)	51.9
Week 36 NRI (n=32)	43.8
Week 36 LOCF (n=31)	51.6
Week 48 Observed (n=24)	62.5
Week 48 NRI (n=32)	46.9
Week 48 LOCF (n=31)	58.1
Week 60 Observed (n=20)	50
Week 60 NRI (n=32)	31.3
Week 60 LOCF (n=31)	51.6
Week 72 Observed (n=17)	64.7
Week 84 Observed (n=17)	64.7
Week 96 Observed (n=13)	61.5
Week 108 Observed (n=9)	66.7
Week 120 Observed (n=3)	100

No statistical analyses for this end point

Secondary: Physician's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

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End point title

Physician's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

End point description

The physician’s assessment of subject’s overall disease activity on a visual analog scale (VAS). The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=31)	-41.4 ( 21.2 )
Week 24 (n=30)	-45.3 ( 21.32 )
Week 36 (n=28)	-43 ( 23.9 )
Week 48 (n=24)	-46.5 ( 18.35 )
Week 60 (n=21)	-42.7 ( 28.17 )
Week 72 (n=17)	-51.1 ( 19.53 )
Week 84 (n=17)	-50.5 ( 16.77 )
Week 96 (n=13)	-47.5 ( 24.42 )
Week 108 (n=9)	-48.3 ( 28.24 )
Week 120 (n=3)	-56.3 ( 5.13 )

No statistical analyses for this end point

Secondary: Parent's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

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End point title

Parent's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

End point description

The parent’s assessment of how the subject’s arthritis is doing overall on a VAS. The VAS is a 100 mm scale, with scores ranging from 0 (very good) to 100 (very bad). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=31)	-28.1 ( 29.91 )
Week 24 (n=30)	-32.2 ( 29.74 )
Week 36 (n=27)	-35.1 ( 27.42 )
Week 48 (n=24)	-35.6 ( 32.19 )
Week 60 (n=21)	-34.5 ( 33.31 )
Week 72 (n=17)	-43.8 ( 25.58 )
Week 84 (n=17)	-42.6 ( 28.62 )
Week 96 (n=13)	-45.8 ( 29.1 )
Week 108 (n=9)	-39.9 ( 37.54 )
Week 120 (n=3)	-47.7 ( 34.96 )

No statistical analyses for this end point

Secondary: Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change from Baseline to Each Visit

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End point title

Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change from Baseline to Each Visit

End point description

The DICHAQ is a self-reported subject-oriented outcome measure, calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The score of each category is calculated as the maximum of the scores for the questions within that category. If aids and devices and/or help from another person are used for a category, a lower category score is adjusted to 2 for that category. A subject must have scores for at least 6 categories in order to compute the DICHAQ score. Total score is derived as average of all categories: 0 (no disability) to 3 (complete disability). Baseline is the last value prior to the first dose of study drug. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=31)	-0.5 ( 0.64 )
Week 24 (n=30)	-0.5 ( 0.69 )
Week 36 (n=27)	-0.6 ( 0.7 )
Week 48 (n=24)	-0.6 ( 0.68 )
Week 60 (n=21)	-0.6 ( 0.71 )
Week 72 (n=16)	-0.9 ( 0.64 )
Week 84 (n=17)	-0.9 ( 0.68 )
Week 96 (n=13)	-0.8 ( 0.56 )
Week 108 (n=9)	-0.8 ( 0.63 )
Week 120 (n=3)	-0.8 ( 1.09 )

No statistical analyses for this end point

Secondary: Active Joint Counts (AJC73): Mean Change from Baseline to Each Visit

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End point title

Active Joint Counts (AJC73): Mean Change from Baseline to Each Visit

End point description

A joint assessment was recorded at all study visits to assess the number of active joints, with a total possible score of 0 (no active joints) to 73 (all active joints). Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 2 (n=32)	-5 ( 6.58 )
Week 4 (n=32)	-6.1 ( 6.69 )
Week 8 (n=32)	-7 ( 5.24 )
Week 12 (n=31)	-7.3 ( 4.52 )
Week 16 (n=31)	-7.1 ( 5.87 )
Week 20 (n=29)	-8 ( 5.68 )
Week 24 (n=30)	-7.2 ( 5.6 )
Week 36 (n=28)	-7.3 ( 5.21 )
Week 48 (n=24)	-8 ( 5.5 )
Week 60 (n=20)	-9.5 ( 7.5 )
Week 72 (n=17)	-10.2 ( 6.64 )
Week 84 (n=17)	-10.4 ( 7.57 )
Week 96 (n=13)	-8.9 ( 7.04 )
Week 108 (n=9)	-5.9 ( 3.33 )
Week 120 (n=3)	-7.3 ( 2.08 )

No statistical analyses for this end point

Secondary: Limitation of Passive Motion (LOM69) Joint Count: Mean Change from Baseline to Each Visit

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End point title

Limitation of Passive Motion (LOM69) Joint Count: Mean Change from Baseline to Each Visit

End point description

Sixty-nine joints were assessed by physical examination. The joints to be examined for LOM were the same as those examined for tenderness, except that the sacroiliac, sternoclavicular, and acromio clavicular joints were excluded. LOM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 621, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 2 (n=32)	-4.5 ( 7.14 )
Week 4 (n=32)	-5.4 ( 6.48 )
Week 8 (n=32)	-5.3 ( 5.02 )
Week 12 (n=31)	-5.6 ( 4.8 )
Week 16 (n=31)	-6.3 ( 6.31 )
Week 20 (n=29)	-6.8 ( 6.63 )
Week 24 (n=30)	-5.6 ( 5.54 )
Week 36 (n=28)	-5.1 ( 5.29 )
Week 48 (n=24)	-5.5 ( 7.06 )
Week 60 (n=20)	-5.5 ( 8.31 )
Week 72 (n=17)	-6.9 ( 7.84 )
Week 84 (n=17)	-8.4 ( 6.9 )
Week 96 (n=13)	-7.5 ( 6.73 )
Week 108 (n=9)	-5.2 ( 3.96 )
Week 120 (n=3)	-6 ( 2.65 )

No statistical analyses for this end point

Secondary: C-reactive Protein (CRP): Mean Change from Baseline to Each Visit

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End point title

C-reactive Protein (CRP): Mean Change from Baseline to Each Visit

End point description

CRP is a laboratory parameter and considered as an efficacy variable. CRP is a general marker of inflammation that is sensitive to acute changes in inflammatory response. CRP is reported using mg/dL. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: mg/dL
arithmetic mean (standard deviation)
Week 12 (n=28)	-0.6 ( 2.65 )
Week 24 (n=28)	-0.2 ( 3.2 )
Week 36 (n=25)	-0.4 ( 3.08 )
Week 48 (n=23)	0.4 ( 2.68 )
Week 60 (n=20)	-0.3 ( 1.83 )
Week 72 (n=17)	-0.7 ( 1.25 )
Week 84 (n=17)	-0.7 ( 1.47 )
Week 96 (n=12)	0.1 ( 1.6 )
Week 108 (n=9)	0.2 ( 1.93 )
Week 120 (n=3)	0.3 ( 0.28 )

No statistical analyses for this end point

Secondary: Tender Joint Count (TJC75): Mean Change from Baseline to Each Visit

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End point title

Tender Joint Count (TJC75): Mean Change from Baseline to Each Visit

End point description

Seventy-five joints or regions were assessed by pressure and joint manipulation on physical examination. Joint tenderness was classified as either present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 2 (n=32)	-2.3 ( 4.62 )
Week 4 (n=32)	-2.8 ( 4.48 )
Week 8 (n=32)	-3.1 ( 4.31 )
Week 12 (n=31)	-2.7 ( 5.09 )
Week 16 (n=31)	-3.5 ( 4.77 )
Week 20 (n=29)	-3.9 ( 5.09 )
Week 24 (n=30)	-3 ( 5.54 )
Week 36 (n=28)	-2.9 ( 5.65 )
Week 48 (n=24)	-4.4 ( 4.85 )
Week 60 (n=20)	-4.5 ( 5.85 )
Week 72 (n=17)	-5.3 ( 5.53 )
Week 84 (n=17)	-4.8 ( 5.2 )
Week 96 (n=13)	-4 ( 5.46 )
Week 108 (n=9)	-1.1 ( 4.73 )
Week 120 (n=3)	-1.3 ( 2.31 )

No statistical analyses for this end point

Secondary: Swollen Joint Count (SJC66): Mean Change from Baseline to Each Visit

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End point title

Swollen Joint Count (SJC66): Mean Change from Baseline to Each Visit

End point description

Sixty-six joints were assessed by physical examination. The joints to be examined for swelling were the same as those examined for tenderness, except that the hip, subtalar, sacroiliac, lumbar spine, thoracic spine, and cervical spine joints were excluded. Joint swelling was classified as present ("1"), absent ("0") or replaced/injected ("9"). Scores range from 0 to 594, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 2 (n=32)	-4.5 ( 6.46 )
Week 4 (n=32)	-5.3 ( 6.63 )
Week 8 (n=32)	-6 ( 5.32 )
Week 12 (n=31)	-6.2 ( 4.24 )
Week 16 (n=31)	-6.1 ( 6.59 )
Week 20 (n=29)	-6.9 ( 5.62 )
Week 24 (n=30)	-6.3 ( 5.83 )
Week 36 (n=28)	-6.2 ( 4.73 )
Week 48 (n=24)	-6.7 ( 5.34 )
Week 60 (n=20)	-8.4 ( 7.15 )
Week 72 (n=17)	-8.9 ( 6.06 )
Week 84 (n=17)	-9.4 ( 7.15 )
Week 96 (n=13)	-8.5 ( 6.89 )
Week 108 (n=9)	-5.8 ( 3.31 )
Week 120 (n=3)	-7.3 ( 2.08 )

No statistical analyses for this end point

Secondary: Pain on Passive Motion (POM75) Joint Count: Mean Change from Baseline to Each Visit

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End point title

Pain on Passive Motion (POM75) Joint Count: Mean Change from Baseline to Each Visit

End point description

Seventy-five joints were assessed by physical examination. The joints to be examined for POM were the same as those examined for tenderness. POM of the joint was classified as present ("1"), absent ("0"), or replaced/injected ("9"). Scores range from 0 to 675, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 2 (n=32)	-3.3 ( 4.5 )
Week 4 (n=32)	-4 ( 4.01 )
Week 8 (n=32)	-4.6 ( 5.17 )
Week 12 (n=31)	-4.9 ( 4.59 )
Week 16 (n=31)	-4.9 ( 4.6 )
Week 20 (n=29)	-5.4 ( 4.81 )
Week 24 (n=30)	-4.1 ( 7.32 )
Week 36 (n=28)	-4.3 ( 7.34 )
Week 48 (n=24)	-5.8 ( 4.42 )
Week 60 (n=20)	-5.9 ( 5.25 )
Week 72 (n=17)	-6.4 ( 5.41 )
Week 84 (n=17)	-6.1 ( 5.34 )
Week 96 (n=13)	5.7 ( 5.12 )
Week 108 (n=9)	-3.6 ( 5.85 )
Week 120 (n=3)	-5.3 ( 1.53 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change from Baseline to Each Visit

End point description

The CHQ-PF50 is a subject-reported outcome measure that includes 50 questions related to physical and mental health, social limitations, and impact on parents and family. Scores for each category were converted to a scale from 0 (implies higher disease activity) to 100 (implies lower disease activity). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Subjects with nonmissing Baseline and at least 1 postbaseline observation are included in the analysis. n=subjects with a nonmissing value at baseline and each visit.

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=29)	17.1 ( 29.48 )
Week 24 (n=28)	24.3 ( 25.77 )
Week 36 (n=24)	25 ( 27.27 )
Week 48 (n=22)	30.9 ( 23.79 )
Week 60 (n=19)	21.8 ( 27.35 )
Week 72 (n=17)	31.5 ( 24.86 )
Week 84 (n=17)	26.2 ( 25.89 )
Week 96 (n=11)	32.7 ( 20.66 )
Week 108 (n=8)	36.9 ( 19.99 )
Week 120 (n=3)	45 ( 17.32 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=31)	30.6 ( 32.14 )
Week 24 (n=30)	31.6 ( 31.91 )
Week 36 (n=27)	36.4 ( 31.26 )
Week 48 (n=23)	31.5 ( 28.39 )
Week 60 (n=21)	29 ( 32.3 )
Week 72 (n=16)	40.6 ( 27 )
Week 84 (n=17)	40 ( 30.44 )
Week 96 (n=13)	34.3 ( 27.88 )
Week 108 (n=9)	37 ( 27.92 )
Week 120 (n=3)	53.7 ( 8.49 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=23)	20.8 ( 32.53 )
Week 24 (n=22)	17.7 ( 29.43 )
Week 36 (n=20)	17.2 ( 25.86 )
Week 48 (n=18)	16 ( 27.28 )
Week 60 (n=16)	20.8 ( 31.91 )
Week 72 (n=13)	26.5 ( 32.25 )
Week 84 (n=13)	20.5 ( 33.29 )
Week 96 (n=9)	30.9 ( 32.76 )
Week 108 (n=7)	23.8 ( 25.2 )
Week 120 (n=2)	33.3 ( 47.14 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations – Physical Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=21)	28.6 ( 32.97 )
Week 24 (n=20)	31.7 ( 35 )
Week 36 (n=18)	30.6 ( 39.3 )
Week 48 (n=17)	27.5 ( 37.24 )
Week 60 (n=15)	34.4 ( 39.07 )
Week 72 (n=12)	36.1 ( 41.34 )
Week 84 (n=12)	34.7 ( 43.5 )
Week 96 (n=8)	41.7 ( 37.8 )
Week 108 (n=6)	47.2 ( 37.14 )
Week 120 (n=1)	66.7 ( 0 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Bodily Pain/Discomfort Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=30)	35 ( 30.6 )
Week 24 (n=29)	36.2 ( 32.99 )
Week 36 (n=26)	38.8 ( 27.76 )
Week 48 (n=23)	41.7 ( 29.64 )
Week 60 (n=20)	39 ( 34.78 )
Week 72 (n=17)	48.2 ( 20.38 )
Week 84 (n=17)	41.2 ( 25.47 )
Week 96 (n=13)	42.3 ( 23.51 )
Week 108 (n=9)	41.1 ( 37.56 )
Week 120 (n=3)	50 ( 17.32 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Behavior Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=29)	5.6 ( 15.78 )
Week 24 (n=28)	4.2 ( 13.58 )
Week 36 (n=27)	0.4 ( 16.87 )
Week 48 (n=24)	3.6 ( 17.04 )
Week 60 (n=21)	-0.3 ( 13.95 )
Week 72 (n=17)	0.1 ( 16.44 )
Week 84 (n=17)	1.5 ( 13.97 )
Week 96 (n=13)	7.1 ( 11.81 )
Week 108 (n=9)	8.9 ( 10.46 )
Week 120 (n=3)	-6.1 ( 31.28 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Global Behavior Item: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=19)	4.5 ( 18.17 )
Week 24 (n=19)	10.8 ( 17.66 )
Week 36 (n=18)	9.2 ( 25.04 )
Week 48 (n=16)	4.1 ( 18.55 )
Week 60 (n=13)	-3.5 ( 20.35 )
Week 72 (n=10)	2 ( 15.31 )
Week 84 (n=11)	-5 ( 14.32 )
Week 96 (n=9)	0 ( 17.68 )
Week 108 (n=6)	-4.2 ( 10.21 )
Week 120 (n=1)	-25 ( 0 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Mental Health Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=31)	3.5 ( 11.12 )
Week 24 (n=30)	3.5 ( 10.76 )
Week 36 (n=27)	4.1 ( 14.01 )
Week 48 (n=24)	5.4 ( 11.88 )
Week 60 (n=21)	2.1 ( 14.02 )
Week 72 (n=17)	5 ( 12.37 )
Week 84 (n=17)	2.6 ( 8.5 )
Week 96 (n=13)	4.2 ( 11.88 )
Week 108 (n=9)	-0.8 ( 15 )
Week 120 (n=3)	-3.3 ( 20.21 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Self Esteem Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=23)	10.6 ( 23.91 )
Week 24 (n=22)	10.5 ( 24.75 )
Week 36 (n=19)	16.8 ( 22.02 )
Week 48 (n=16)	15.2 ( 22.6 )
Week 60 (n=14)	10.2 ( 22.53 )
Week 72 (n=13)	-2.8 ( 31.78 )
Week 84 (n=13)	9.4 ( 18.52 )
Week 96 (n=9)	6.9 ( 19.87 )
Week 108 (n=6)	-4.2 ( 10.87 )
Week 120 (n=1)	4.2 ( 0 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) General Health Perceptions Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=26)	0.7 ( 14.27 )
Week 24 (n=25)	3.8 ( 14.98 )
Week 36 (n=22)	6.2 ( 15.99 )
Week 48 (n=19)	7.2 ( 13.36 )
Week 60 (n=18)	0.7 ( 10.65 )
Week 72 (n=15)	9.1 ( 10.1 )
Week 84 (n=15)	7.2 ( 13.03 )
Week 96 (n=11)	10.9 ( 16 )
Week 108 (n=7)	9 ( 16.61 )
Week 120 (n=3)	4.7 ( 12.92 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Change in Health Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=30)	1.4 ( 1.75 )
Week 24 (n=29)	1.7 ( 1.67 )
Week 36 (n=25)	1.7 ( 1.8 )
Week 48 (n=22)	1.7 ( 2.4 )
Week 60 (n=20)	1.3 ( 2.57 )
Week 72 (n=16)	1.6 ( 2.13 )
Week 84(n=16)	1.3 ( 1.98 )
Week 96 (n=12)	1.5 ( 2.02 )
Week 108 (n=8)	0.9 ( 2.7 )
Week 120 (n=3)	2.3 ( 0.58 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Emotional Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=30)	11.4 ( 26.12 )
Week 24 (n=28)	19 ( 28.59 )
Week 36 (n=26)	29.2 ( 33.1 )
Week 48 (n=23)	34.1 ( 33.98 )
Week 60 (n=20)	31.7 ( 32.4 )
Week 72 (n=16)	34.4 ( 36.37 )
Week 84 (n=16)	27.6 ( 41.69 )
Week 96 (n=11)	43.9 ( 40.15 )
Week 108 (n=8)	46.9 ( 40.81 )
Week 120 (n=2)	62.5 ( 41.25 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Parental Impact - Time Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=30)	4.6 ( 24.5 )
Week 24 (n=28)	13.5 ( 28.59 )
Week 36 (n=26)	21.8 ( 24.24 )
Week 48 (n=23)	18.4 ( 24.76 )
Week 60 (n=20)	13.3 ( 31.55 )
Week 72 (n=16)	22.2 ( 30.09 )
Week 84 (n=16)	17.4 ( 35.13 )
Week 96 (n=12)	20.4 ( 27.15 )
Week 108 (n=8)	15.3 ( 25.85 )
Week 120 (n=2)	55.6 ( 62.85 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Family Activities Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=30)	8.3 ( 28.41 )
Week 24 (n=28)	17.6 ( 24.15 )
Week 36 (n=26)	20 ( 28.5 )
Week 48 (n=23)	16.8 ( 26.43 )
Week 60 (n=20)	14.8 ( 30.9 )
Week 72 (n=16)	17.2 ( 31.43 )
Week 84 (n=16)	18.2 ( 30.27 )
Week 96 (n=12)	19.4 ( 27.6 )
Week 108 (n=8)	20.8 ( 29.38 )
Week 120 (n=2)	68.8 ( 20.62 )

No statistical analyses for this end point

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change from Baseline to Each Visit

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End point title

Child's Health Questionnaire Parent Form (CHQ-PF50) Family Cohesion Category: Mean Change from Baseline to Each Visit

End point description

End point type

Secondary

End point timeframe

Baseline and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

End point values	Adalimumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)
Week 12 (n=30)	2.5 ( 14 )
Week 24 (n=28)	4.3 ( 23.28 )
Week 36 (n=26)	5.6 ( 20.66 )
Week 48 (n=23)	3.7 ( 15.61 )
Week 60 (n=20)	4.8 ( 16.66 )
Week 72 (n=16)	7.2 ( 29.15 )
Week 84 (n=16)	8.4 ( 39.19 )
Week 96 (n=12)	18.8 ( 35.36 )
Week 108 (n=8)	19.4 ( 35.3 )
Week 120 (n=2)	-27.5 ( 38.89 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months); SAEs were collected from the time informed consent was obtained (33.5 months)

Adverse event reporting additional description

A treatment-emergent AE (TEAE) is defined as any AE with onset or worsening reported by a subject from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the subject.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

15.1

Reporting group title

Adalimumab

Reporting group description

Adalimumab 24 mg/m^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Subjects could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU).Visits beyond Week 24 occurred every 12 weeks for those subjects who continued in the study.

Serious adverse events	Adalimumab
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 32 (15.63%)
number of deaths (all causes)	0
number of deaths resulting from adverse events
Gastrointestinal disorders
Dental caries
subjects affected / exposed	1 / 32 (3.13%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Juvenile arthritis
subjects affected / exposed	1 / 32 (3.13%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Gastroenteritis rotavirus
subjects affected / exposed	1 / 32 (3.13%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Varicella
subjects affected / exposed	1 / 32 (3.13%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Metabolism and nutrition disorders
Type 1 diabetes mellitus
subjects affected / exposed	1 / 32 (3.13%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Adalimumab
Total subjects affected by non serious adverse events
subjects affected / exposed	27 / 32 (84.38%)
Investigations
Body temperature increased
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	3
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	3
Nervous system disorders
Headache
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	2
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	7 / 32 (21.88%)
occurrences all number	11
Eye disorders
Uveitis
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	2
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	4 / 32 (12.50%)
occurrences all number	4
Vomiting
subjects affected / exposed	5 / 32 (15.63%)
occurrences all number	5
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	6 / 32 (18.75%)
occurrences all number	11
Rhinorrhoea
subjects affected / exposed	6 / 32 (18.75%)
occurrences all number	7
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	4 / 32 (12.50%)
occurrences all number	5
Musculoskeletal and connective tissue disorders
Juvenile arthritis
subjects affected / exposed	4 / 32 (12.50%)
occurrences all number	9
Infections and infestations
Acute tonsillitis
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	4
Bronchitis
subjects affected / exposed	6 / 32 (18.75%)
occurrences all number	7
Cystitis
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	2
Ear infection
subjects affected / exposed	3 / 32 (9.38%)
occurrences all number	4
Gastroenteritis
subjects affected / exposed	4 / 32 (12.50%)
occurrences all number	4
Gastroenteritis viral
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	2
H1N1 influenza
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	2
Nasopharyngitis
subjects affected / exposed	8 / 32 (25.00%)
occurrences all number	11
Otitis media
subjects affected / exposed	5 / 32 (15.63%)
occurrences all number	9
Pharyngitis
subjects affected / exposed	3 / 32 (9.38%)
occurrences all number	6
Pharyngitis streptococcal
subjects affected / exposed	3 / 32 (9.38%)
occurrences all number	3
Pneumonia
subjects affected / exposed	2 / 32 (6.25%)
occurrences all number	2
Rhinitis
subjects affected / exposed	4 / 32 (12.50%)
occurrences all number	5
Sinusitis
subjects affected / exposed	3 / 32 (9.38%)
occurrences all number	3
Upper respiratory tract infection
subjects affected / exposed	6 / 32 (18.75%)
occurrences all number	11

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

26 Aug 2008

To add study visits to gather additional safety data and to shorten the intervals between visits, and change study duration from based on age (10 years) to based on age and weight.

08 Jan 2009

To clarify and update study procedures; include BSA dosing and dosing diaries; and update criteria for JIA diagnosis to include International League of Associations for Rheumatology (ILAR) classification.

06 Jul 2009

To extend the study population to include children in the EU who meet the study criteria; update the classification of JIA to add back in ‘moderately to severely’ in the description and to include polyarticular course JIA; revise inclusion exclusion criteria for safety reasons (eg, normal cardiopulmonary and neurological exams, parent/legal guardian responsible for storage and handling of study drug, procedures following positive purified protein derivative [PPD] test, and exclusionary concomitant medications); update conditions in which a subject should be withdrawn; and include (EU) and update (US) injection instructions for adalimumab.

29 Oct 2009

To extend the study for subjects in the EU who have reached 4 years of age and weight ≥ 15 kg for up to 1 additional year to allow time for transition to an appropriate treatment.

23 Aug 2010

To add anti-adalimumab antibody (AAA) assay; clarify that subjects beginning commercial adalimumab immediately after the trial will not be required to have a 70-day follow-up call; expand anti-nuclear antibody (ANA)/double-stranded DNA (dsDNA) test to include US subjects; and include previous Disease-Modifying Anti-Rheumatic Drug (DMARD) failure as part of inclusion criteria for subjects in the EU.

01 May 2012

To include annual tuberculosis tests.

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.

None reported

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Clinical trials

Clinical Trial Results: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

Primary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs)

Secondary: Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24

Secondary: Mean Serum Adalimumab Trough Concentrations at Week 0, Week 12, and Week 24

Secondary: Hemoglobin: Mean Change From Baseline to Each Visit

Secondary: Hemoglobin: Mean Change From Baseline to Each Visit

Secondary: Hematocrit: Mean Change From Baseline to Each Visit

Secondary: Hematocrit: Mean Change From Baseline to Each Visit

Secondary: Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit

Secondary: Red Blood Cell (RBC) Count: Mean Change From Baseline to Each Visit

Secondary: Platelets: Mean Change From Baseline to Each Visit

Secondary: Platelets: Mean Change From Baseline to Each Visit

Secondary: White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit

Secondary: White Blood Cell (WBC) Count: Mean Change From Baseline to Each Visit

Secondary: Neutrophils: Mean Change From Baseline to Each Visit

Secondary: Neutrophils: Mean Change From Baseline to Each Visit

Secondary: Lymphocytes: Mean Change From Baseline to Each Visit

Secondary: Lymphocytes: Mean Change From Baseline to Each Visit

Secondary: Monocytes: Mean Change From Baseline to Each Visit

Secondary: Monocytes: Mean Change From Baseline to Each Visit

Secondary: Eosinophils: Mean Change From Baseline to Each Visit

Secondary: Eosinophils: Mean Change From Baseline to Each Visit

Secondary: Basophils: Mean Change From Baseline to Each Visit

Secondary: Basophils: Mean Change From Baseline to Each Visit

Secondary: Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit

Secondary: Alanine Aminotransferase (SGPT/ALT): Mean Change From Baseline to Each Visit

Secondary: Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit

Secondary: Aspartate Aminotransferase (SGOT/AST): Mean Change From Baseline to Each Visit

Secondary: Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit

Secondary: Alkaline Phosphatase (ALP): Mean Change From Baseline to Each Visit

Secondary: Creatine Phosphokinase: Mean Change From Baseline to Each Visit

Secondary: Creatine Phosphokinase: Mean Change From Baseline to Each Visit

Secondary: Total Bilirubin: Mean Change From Baseline to Each Visit

Secondary: Total Bilirubin: Mean Change From Baseline to Each Visit

Secondary: Creatinine: Mean Change From Baseline to Each Visit

Secondary: Creatinine: Mean Change From Baseline to Each Visit

Secondary: Uric Acid: Mean Change From Baseline to Each Visit

Secondary: Uric Acid: Mean Change From Baseline to Each Visit

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 30% Response (PedACR30)

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 30% Response (PedACR30)

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 50% Response (PedACR50)

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 50% Response (PedACR50)

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 70% Response (PedACR70)

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 70% Response (PedACR70)

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 90% Response (PedACR90)

Secondary: Percentage of Subjects Achieving Pediatric American College of Rheumatology 90% Response (PedACR90)

Secondary: Physician's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

Secondary: Physician's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

Secondary: Parent's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

Secondary: Parent's Global Assessment of Disease Activity: Mean Change from Baseline to Each Visit

Secondary: Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change from Baseline to Each Visit

Secondary: Disability Index of Child Health Assessment Questionnaire (DICHAQ): Mean Change from Baseline to Each Visit

Secondary: Active Joint Counts (AJC73): Mean Change from Baseline to Each Visit

Secondary: Active Joint Counts (AJC73): Mean Change from Baseline to Each Visit

Secondary: Limitation of Passive Motion (LOM69) Joint Count: Mean Change from Baseline to Each Visit

Secondary: Limitation of Passive Motion (LOM69) Joint Count: Mean Change from Baseline to Each Visit

Secondary: C-reactive Protein (CRP): Mean Change from Baseline to Each Visit

Secondary: C-reactive Protein (CRP): Mean Change from Baseline to Each Visit

Secondary: Tender Joint Count (TJC75): Mean Change from Baseline to Each Visit

Secondary: Tender Joint Count (TJC75): Mean Change from Baseline to Each Visit

Secondary: Swollen Joint Count (SJC66): Mean Change from Baseline to Each Visit

Secondary: Swollen Joint Count (SJC66): Mean Change from Baseline to Each Visit

Secondary: Pain on Passive Motion (POM75) Joint Count: Mean Change from Baseline to Each Visit

Secondary: Pain on Passive Motion (POM75) Joint Count: Mean Change from Baseline to Each Visit

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change from Baseline to Each Visit

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Global Health Category: Mean Change from Baseline to Each Visit

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change from Baseline to Each Visit

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Physical Functioning Category: Mean Change from Baseline to Each Visit

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change from Baseline to Each Visit

Secondary: Child's Health Questionnaire Parent Form (CHQ-PF50) Role/Social Limitations/Emotional/Behavioral Category: Mean Change from Baseline to Each Visit

Clinical Trial Results:
Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)