A Study of Duration of Maintained Efficacy in Rheumatoid Arthritis (RA) Patients Off Treatment With MRA(a Development Code of Tocilizumab, an Anti IL-6 Receptor Monoclonal Antibody.)
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00661284
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy throughout study
- Secondary Outcome Measures
Name Time Method Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies. throughout study Efficacy: Time course of DAS28 during the treatment-free period in the present study throughout study 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
Trial Locations
- Locations (5)
Kanto region
🇯🇵Kanto, Japan
Kyushu region
🇯🇵Kyushu, Japan
Chugoku region
🇯🇵Chugoku, Japan
Sikoku region
🇯🇵Sikoku, Japan
Tohoku region
🇯🇵Tohoku, Japan