Juvenile Rheumatoid Arthritis MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731
Sponsors
Abbott Japan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to evaluate the safety, efficacy and 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Number of Subjects Achieving PedACR50 and PedACR70 Responses 2) Number of Subjects Achieving PedACR 30/50/70 Responses 3) Mean Serum Adalimumab Concentration 4) Number of Subjects Positive for Anti-adalimumab Antibodies (AAA);Timepoint(s) of evaluation of this end point: 1) Week 16 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 3) Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60 4) Week 2, 4, 8, 16 and 24, and every 12 weeks after Week 24 | — |
Countries
Japan
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed