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Planned recruitment target not reached
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This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with confirmed rheumatoid arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention administered in this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with a 28-Joint Disease Activity Score (DAS28) < 2.6 at Week 24 | Week 24 | |
| Number of Participants with Adverse Events | Up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Tender Joint Count-28 Joints (TJC28) < or = 1 at Week 12 and Week 24 | Week 12 and Week 24 | |
| Percentage of Participants with Swollen Joint Count-28 Joints (SJC28) < or = 1 at Week 12 and Week 24 | Week 12 and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with confirmed rheumatoid arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Khaled Uni Hospital; Oncology | Riyadh | 11472 | Saudi Arabia | |||
| King Fahad Medical City; Gastroentrology |
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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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| Percentage of Participants with C-Reactive Protein (CRP) < or = 1mg/dL at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with Participant Global Health (PGH) < or = 1/10 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with Clinical Disease Activity Index (CDAI) < or = 2.8 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with DAS28 < or = 3.2 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with CDAI < or = 10 at Week 12 and Week 24 | Week 12 and Week 24 |
| Percentage of Participants with DAS28 < 2.6 at Week 12 | Week 12 |
| Mean Change in DAS28 | Baseline, Week 12, and Week 24 |
| Mean Change in CDAI | Baseline, Week 12, and Week 24 |
| Mean Change in TJC | Baseline and Week 24 |
| Mean Change in SJC | Baseline and Week 24 |
| Mean Change in CRP | Baseline and Week 24 |
| Mean Change in PGH | Baseline and Week 24 |
| Riyadh |
| 11525 |
| Saudi Arabia |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |