Clinical Trial Results:
A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
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Summary
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EudraCT number |
2009-012520-84 |
Trial protocol |
HU DE BE CZ FR SI ES SE SK LT NL LV GR DK IT Outside EU/EEA |
Global end of trial date |
30 Jan 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jun 2016
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First version publication date |
18 Jul 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
B1801014
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00962741 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Alias: 0881A1-3338 | ||
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Sponsors
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Sponsor organisation name |
Pfizer Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000299-PIP01-08 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Dec 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jan 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), or psoriatic arthritis (PsA).
Part 2: To assess the long-term safety of etnaercept in subjects with extended oligoarticular JIA, ERA, or PsA.
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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 Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Nov 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 3
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Country: Number of subjects enrolled |
Norway: 1
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Country: Number of subjects enrolled |
Poland: 15
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Country: Number of subjects enrolled |
Slovakia: 2
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Country: Number of subjects enrolled |
Slovenia: 2
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Country: Number of subjects enrolled |
Spain: 3
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Country: Number of subjects enrolled |
Belgium: 10
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Country: Number of subjects enrolled |
Czech Republic: 5
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Country: Number of subjects enrolled |
France: 7
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Country: Number of subjects enrolled |
Germany: 16
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Country: Number of subjects enrolled |
Hungary: 10
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Country: Number of subjects enrolled |
Italy: 3
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Country: Number of subjects enrolled |
Latvia: 9
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Country: Number of subjects enrolled |
Lithuania: 7
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Country: Number of subjects enrolled |
Serbia: 14
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Country: Number of subjects enrolled |
Australia: 4
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Country: Number of subjects enrolled |
Russian Federation: 11
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Country: Number of subjects enrolled |
Colombia: 3
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Country: Number of subjects enrolled |
Mexico: 2
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Worldwide total number of subjects |
127
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EEA total number of subjects |
93
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
38
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Adolescents (12-17 years) |
89
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
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Pre-assignment
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Screening details |
Total subjects enrolled were 127 in 19 countries from 23 Novemeber 2009 to 30 January 2013. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Etanercept | ||||||||||||||||||
Arm description |
Etanercept was administered 0.8 milligram per kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Etanercept
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Etanercept
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Reporting group description |
Etanercept was administered 0.8 milligram per kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Etanercept
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Reporting group description |
Etanercept was administered 0.8 milligram per kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. | ||
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End point title |
Percentage of Subjects With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 [1] | ||||||||
End point description |
ACR Pedi 30 response: greater than or equal to (>=)30 percent (%) improvement from baseline in 3 of 6 criteria with worsening greater than (>)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. Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of the study medication.
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End point type |
Primary
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End point timeframe |
Week 12
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| 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 data was planned to be reported for this endpoint. |
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| Notes [2] - ‘N’(Number of subjects analyzed) signified those subjects who were evaluable for measure at week 12. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of subjects With an ACR Pedi 30 Response | ||||||||||||||||||||||||||||
End point description |
ACR Pedi 30 response: >=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) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | ||||||||||||||||||||||||||||
End point description |
ACR Pedi 30 response: >=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) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | ||||||||||||||||||||||||||||
End point description |
ACR Pedi 30 response: >=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) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). ERA: subjects with arthritis (Ar) or (/) enthesitis, any 2: sacroiliac joint tenderness/inflammatory (Ifm) lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6 years; acute anterior uveitis (AAU)/AAU first-degree relative.
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | ||||||||||||||||||||||||||||
End point description |
ACR Pedi 30 response: >= 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) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 50 Response | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 50 Response: eoJIA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 50 Response: ERA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 50 Response: PsA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 70 Response | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 70 Response: eoJIA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 70 Response: ERA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 70 Response: PsA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 90 Response | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 90 Response:eoJIA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Secondary
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End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With an ACR Pedi 90 Response: ERA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With an ACR Pedi 90 Response: PsA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With an ACR Pedi 100 Response | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With an ACR Pedi 100 Response: eoJIA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With an ACR Pedi 100 Response: ERA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA,sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With an ACR Pedi 100 Response: PsA Sub-population | ||||||||||||||||||||||||||||
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: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Physician's Global Assessment (PGA) of Disease Activity | ||||||||||||||||||||||||||||||
End point description |
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | ||||||||||||||||||||||||||||||
End point description |
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. ERA: subjects with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | ||||||||||||||||||||||||||||||
End point description |
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Subject/Parent Global Assessment | ||||||||||||||||||||||||||||||
End point description |
Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Subject/Parent Global Assessment: eoJIA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Subject/Parent Global Assessment: ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Subject/Parent Global Assessment: PsA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Subject/Parent Global Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Active Joints | ||||||||||||||||||||||||||||||
End point description |
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Active Joints: eoJIA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Active Joints: ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Active Joints: PsA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Joints With Limitation of Motion | ||||||||||||||||||||||||||||||
End point description |
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Joints With Limitation of Motion: eoJIA Sub-population | ||||||||||||||||||||||||||||||
End point description |
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Joints With Limitation of Motion: ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male>6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Number of Joints With Limitation of Motion: PsA Sub-population | ||||||||||||||||||||||||||||||
End point description |
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
C-reactive Protein (CRP) | ||||||||||||||||||||||||||||||
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. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
C-reactive Protein (CRP): eoJIA Sub-population | ||||||||||||||||||||||||||||||
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. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
C-reactive Protein (CRP): ERA Sub-population | ||||||||||||||||||||||||||||||
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. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
C-reactive Protein (CRP): PsA Sub-population | ||||||||||||||||||||||||||||||
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. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Pain Assessment | ||||||||||||||||||||||||||||||
End point description |
Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Pain Assessment: eoJIA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Pain Assessment: ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Pain Assessment: PsA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Pain Assessment was assessed by the subject's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Duration of Morning Stiffness | ||||||||||||||||||||||||||||||
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). mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Duration of Morning Stiffness: eoJIA Sub-population | ||||||||||||||||||||||||||||||
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). eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Duration of Morning Stiffness: ERA Sub-population | ||||||||||||||||||||||||||||||
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). ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history;human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Duration of Morning Stiffness: PsA Sub-population | ||||||||||||||||||||||||||||||
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). PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition | ||||||||||||||||||||||||||||
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. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | ||||||||||||||||||||||||||||
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.
eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | ||||||||||||||||||||||||||||
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.
ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter's syndrome history; humanleukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | ||||||||||||||||||||||||||||
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.
PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Childhood Health Assessment Questionnaire (CHAQ) Score | ||||||||||||||||||||||||||||||
End point description |
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’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. mITT population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | ||||||||||||||||||||||||||||||
End point description |
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’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. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’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. ERA: subjects with Ar /enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | ||||||||||||||||||||||||||||||
End point description |
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report subjects’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. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Tender Entheseal Assessment for ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If >33 tender entheseal counts were missing, total number of tender entheses was defined as missing. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Overall Back Pain Score for ERA Sub-population | ||||||||||||||||||||||||||||||
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. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Nocturnal Back Pain Score for ERA Sub-population | ||||||||||||||||||||||||||||||
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. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Modified Schober's Test for ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Modified Schober’s Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The subject then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.
ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | ||||||||||||||||||||||||||||||
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% 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. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | ||||||||||||||||||||||||||||||
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 subjects who were scored as a 0 or 1. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Number of subjects With Adverse Events (AEs) | ||||||||||||||||||||
End point description |
An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRs), malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events (SAEs) including infections. Safety population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||
End point timeframe |
Week 12, Week 96
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Number of Subjects With Adverse Events (AEs): eoJIA Subpopulation | ||||||||||||||||||||
End point description |
An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting AEs included medically important infections, infections considered preventable by vaccination, ISRs, malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events including infections. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||
End point timeframe |
Week 12, Week 96
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Number of Subjects With Adverse Events (AEs): ERA Sub-population | ||||||||||||||||||||
End point description |
An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting AEs included medically important infections, infections considered preventable by vaccination, ISRs, malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events including infections. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen-B27;Ar in male >6yrs; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||
End point timeframe |
Week 12, Week 96
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||||||
End point title |
Number of Subjects With Adverse Events (AEs): PsA Sub-population | ||||||||||||||||||||
End point description |
An AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Number of subjects reporting AEs included medically important infections, infections considered preventable by vaccination, ISRs, malignancies, AEs, excluding infections and injection site reactions, infections and serious adverse events including infections. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||
End point timeframe |
Week 12, Week 96
|
||||||||||||||||||||
|
|||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||
|
|||||||||||||||||
End point title |
Tanner Assessment Score by Age Group | ||||||||||||||||
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). Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 96
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Tanner Assessment Score by Age Group for eoJIA Sub-population | ||||||||||||||||||||||||||||||||||||||||
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). eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 96
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Tanner Assessment Score by Age Group for ERA Sub-population | ||||||||||||||||
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). ERA: subjects with Ar/enthesitis, any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 96
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Tanner Assessment Score by Age Group for PsA Sub-population | ||||||||||||||||
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). PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 96
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||
End point title |
Height z-Score by Age Group | ||||||||||||||||||
End point description |
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Height z-Score by Age Group for eoJIA Sub-population | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. eoJIA sub-population: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Height z-Score by Age Group for ERA Sub-population | ||||||||||||||||||
End point description |
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||
End point title |
Height z-Score by Age Group for PsA Sub-population | ||||||||||||||||||
End point description |
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Weight z-Scores by Age Group | ||||||||||||||||||||||||||||||
End point description |
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96.
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Weight z-Scores by Age Group for eoJIA Sub-population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Weight z-Scores by Age Group for ERA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
End point title |
Weight z-Scores by Age Group for PsA Sub-population | ||||||||||||||||||||||||||||||
End point description |
Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Body Mass Index (BMI) z-Score by Age Group | ||||||||||||||||||
End point description |
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. Safety population: subjects who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | ||||||||||||||||||
End point description |
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. ERA: subjects with Ar/enthesitis,any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
|
||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||
End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||
End point title |
Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | ||||||||||||||||||
End point description |
BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Other pre-specified
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End point timeframe |
Baseline, Week 12, Week 48, Week 72, Week 96
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Subjects With Anti-etanercept Antibodies | ||||||||||||||
End point description |
Safety population included all subjects who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Other pre-specified
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End point timeframe |
Baseline up to Week 12, Week 48, Week 96
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Subjects With Anti-etanercept Antibodies: eoJIA Sub-population | ||||||||||||||
End point description |
eoJIA: subjects with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Other pre-specified
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End point timeframe |
Baseline up to Week 12, Week 48, Week 96
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Subjects With Anti-etanercept Antibodies: ERA Sub-population | ||||||||||||||
End point description |
ERA: subjects with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter’s syndrome history; human leukocyte antigen; Ar in male >6years; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Other pre-specified
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End point timeframe |
Baseline up to Week 12, Week 48, Week 96
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Subjects With Anti-etanercept Antibodies: PsA Sub-population | ||||||||||||||
End point description |
PsA: subjects with 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. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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End point type |
Other pre-specified
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End point timeframe |
Baseline up to Week 12, Week 48, Week 96
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Subjects With Neutralizing Anti-etanercept Antibodies | ||||||
End point description |
Safety population included all subjects who received at least 1 dose of the study medication.
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End point type |
Other pre-specified
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End point timeframe |
Baseline up to Week 12, Week 48, Week 96
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Screening up to Week 96
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Adverse event reporting additional description |
The same event may appear as both an AE and a Serious Adverse Event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
Etanercept
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Reporting group description |
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Nov 2009 |
1.AEs and SAEs were collected until 30 days after the last dose of investigational product for subjects who completed the Week 96 visit and did not consent to participate in the long-term extension study.
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05 May 2011 |
1. AEs included progression/worsening of underlying disease.
2. AEs included signs or symptoms resulting from medication errors.
3. Lack of efficacy was reported as an AE when it has been associated with a SAE.
4. Added reporting requirements for Potential Cases of Drug-Induced Liver Injury.
5. Testing for direct and indirect bilirubin added to routine serum chemistry panel.
6. Testing for evaluation of potential Hy’s Law cases added.
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02 Jul 2012 |
1. Revised to indicate that the potential exists for a requirement for follow-up of AEs regardless of the investigator’s assessment of causality.
2. Added that any non-serious AE that was determined by the Sponsor to be serious has been reported by the Sponsor as an SAE and that to assist in the determination of case seriousness further information may be requested from the investigator.
3. Revised the active reporting period for SAEs and added the necessity to report all SAEs after the active reporting period regardless of causality. In addition, language regarding the active reporting period and the reporting period for all AEs was revised for clarification. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Results include data for Part 1 (up to Week 12) and Part 2 (up to week 96) of the study. | |||
