Phase 3
N=25
Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
Juvenile Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00690573 ↗Enrolled (actual)
25
Serious AEs
24.0%
Results posted
Apr 2011
Primary outcome: Primary: Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 — 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Biological)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 |
23 | — |
| SECONDARY Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16 |
22; 15 | — |
| SECONDARY Number of Subjects Achieving PedACR 30/50/70 Responses |
15; 16; 19; 21; 22; 21 | — |
| SECONDARY Mean Serum Adalimumab Concentration |
5.24; 5.46; 6.15; 5.73; 5.79; 7.60 | — |
| SECONDARY Number of Subjects Positive for Anti-adalimumab Antibodies (AAA) |
4; 6 | — |
Summary
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria
- Diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) according to the criteria of the American College on Rheumatology (ACR)
- Disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (NSAIDs) or methotrexate (MTX)
- Presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness)
- Stable dosage of MTX for at least 12 weeks prior to the screening visit or discontinuation of MTX at least 14 days prior to baseline visit (Day 1)
- Discontinuation of disease-modifying antirheumatic drugs (DMARDs) other than MTX at least 28 days before screening visit
Exclusion Criteria
- History of inflammatory joint disease other than JRA
- Functional class IV JRA by ACR criteria
- Clinically significant cardiac disease or laboratory abnormalities
- Any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Data sourced from ClinicalTrials.gov (NCT00690573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.