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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| â | Subject who have participated in previous studies and 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. |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subject who have participated in previous studies
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Kimura | Chugai Pharmaceutical,Clinical Research Department 1 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku region | Chugoku | Japan | ||||
| Kanto region |
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| 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 |
| Kanto |
| Japan |
| Kyushu region | Kyushu | Japan |
| Sikoku region | Sikoku | Japan |
| Tohoku region | TÅhoku | Japan |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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