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This observational study will assess the efficacy and safety of combination of rituximab (MabThera) and methotrexate in participants with active refractory rheumatoid arthritis (RA) who have failed to respond to a single course of anti-tumor necrosis factor (TNF) therapy in routine clinical practice. Data will be collected from participants for 12 months after the first dose of rituximab or a minimum of 6 months following a rituximab re-treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab + Methotrexate | All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score Based on 28-joints Count (DAS28) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Re-treatment With Rituximab Within 6 Months of the First Treatment | Up to 5 years | |
| Disease Activity Score Based on 28-joints Count (DAS28) 6 Months After the Re-treatment With Rituximab | 6 Months After the Re-treatment With Rituximab (up to 5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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All participants with active refractory RA who were eligible to receive treatment with methotrexate and rituximab in the Investigators' opinion as per the routine clinical practice following inadequate response to a single cycle of anti-TNF therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beirut | 11-236 | Lebanon | ||||
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Demographics of Participants Eligible to Receive Rituximab | Baseline |
| Number of Participants With Adverse Events | 5 years |
| Beirut |
| 99999 |
| Lebanon |
| Beirut | Lebanon |
| Byblos | 1401 | Lebanon |
| Tripoli | 371 Tripoli | Lebanon |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |