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This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RoActemra/Actemra | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | stable dose |
| |
| tocilizumab [RoActemra/Actemra] |
| Measure | Description | Time Frame |
|---|---|---|
| Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale | from baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological changes in the hand according to the modified Sharp scale | from baseline to Week 24 | |
| Change in Ritchie articular index | from baseline to Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| Drug |
8 mg/kg intravenously every 4 weeks, 24 weeks |
|
| Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24 |
| Weeks 12 and 24 |
| Change in pain: Visual analogue scale (VAS) | from baseline to Week 24 |
| Change in disability: Stanford Health Assessment Questionnaire | from baseline to Week 24 |
| Change in FACIT-fatigue questionnaire | from baseline to Week 24 |
| Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR) | from baseline to Week 28 |
| Change in C-reactive protein | from baseline to Week 24 |
| Change in immunologic parameters: Rheumatic factor/anti-CCP | from baseline to Week 24 |
| Safety: Incidence of adverse events | approximately 2 years |
| 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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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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