Rheumatoid Arthritis Clinical Trial
Official title:
A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA
Verified date | July 2012 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Observational |
A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment
Status | Completed |
Enrollment | 189 |
Est. completion date | May 2010 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies. Exclusion Criteria: - Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Japan | Chugoku region | Chugoku | |
Japan | Kanto region | Kanto | |
Japan | Kyushu region | Kyushu | |
Japan | Sikoku region | Sikoku | |
Japan | Tohoku region | Tohoku |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies. | every 4th week up to the 48th week | No | |
Primary | Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy | throughout study | No | |
Secondary | Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies. | throughout study | No | |
Secondary | Efficacy: Time course of DAS28 during the treatment-free period in the present study | throughout study | No | |
Secondary | Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study. | throughout study | No |
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