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 MRA012JP
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 MRA012JP.
Status | Completed |
Enrollment | 241 |
Est. completion date | June 2009 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion criteria - Patients must suffer from RA, and must have participated in the preceding study. - Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography. Exclusion criteria - Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug - Patients who have not been registered by 3 months after week 52 of the preceding 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 | Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP) | 0W,4W,8W,12W,LOBS | No | |
Primary | Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria | 0W,4W,8W,12W,LOBS | No | |
Secondary | Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set | 0W,4W,8W,12W,LOBS | No | |
Secondary | Frequency, severity, and seriousness of adverse events and adverse drug reactions | Throughout study | Yes |
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