Rheumatoid Arthritis Clinical Trial
Official title:
An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP
Verified date | August 2013 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.
Status | Completed |
Enrollment | 42 |
Est. completion date | June 2009 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion criteria - RA patients who participated in the previous studies - Patients who completed the last observation in the previous studies - Patients who were confirmed to have no problems with safety in the previous studies. Exclusion criteria - Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product - Patients who were not enrolled by 3 months after the last observation day of the previous study |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study. | throughout study | No | |
Secondary | Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. | Week 0, then every 4 Week | No |
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