A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis
- Conditions
- Juvenile Rheumatoid ArthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2014-004558-33-Outside-EU/EEA
- Lead Sponsor
- Abbott Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 25
•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
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study was to evaluate the safety, efficacy and<br>pharmacokinetics including immunogenicity (measured as anti-adalimumab antibody (AAA) of fixed dose adalimumab eow in Japanese subjects with polyarticular JRA.;Secondary Objective: The secondary objective of this study was to confirm the similarity between the data obtained from this study and those from study DE038 conducted in western subjects with JRA.;Primary end point(s): Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16;Timepoint(s) of evaluation of this end point: 16 Weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Number of Subjects Achieving PedACR50 and PedACR70 Responses<br>2) Number of Subjects Achieving PedACR 30/50/70 Responses<br>3) Mean Serum Adalimumab Concentration<br>4) Number of Subjects Positive for Anti-adalimumab Antibodies (AAA);Timepoint(s) of evaluation of this end point: 1) Week 16<br>2) Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit <br>3) Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60<br>4) Week 2, 4, 8, 16 and 24, and every 12 weeks after Week 24