Rheumatoid Arthritis
Conditions
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
Interventions
None listed
Sponsors
Chugai Pharmaceutical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed