Status:
COMPLETED
Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
Lead Sponsor:
Abbott
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Juvenile Rheumatoid Arthritis
Eligibility:
All Genders
4-17 years
Phase:
PHASE3
Brief Summary
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
Detailed Description
This was an open-label long-term study that was completed following study drug approval in Japan for the treatment of JRA. Data are presented through Week 144 and for the final visit.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00690573
Start Date
May 1 2008
End Date
September 1 2011
Last Update
September 10 2012
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 47248
Aichi, Japan
2
Site Reference ID/Investigator# 47253
Fukuoka, Japan
3
Site Reference ID/Investigator# 47251
Hyōgo, Japan
4
Site Reference ID/Investigator# 47254
Kagoshima, Japan