Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DMARD · 1 trial · 1 indication
The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.
| Arm | Type | Description |
|---|---|---|
| Part 1: All patients | EXPERIMENTAL | - |
| Part 2 A: Sustained clinical remission | EXPERIMENTAL | - |
| Part 2 B: Low disease activity | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DMARD | DRUG | non-biological disease-modifying antirheumatic drugs at stable dose |
| methotrexate | DRUG | stable dose |
| tocilizumab [RoActemra/Actemra] | DRUG | 162 mg subcutaneously (SC) qw, Weeks 1-24 |
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Active rheumatoid arthritis (DAS28-ESR \> 3.2), according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria of \> 6 months duration * Patients with intolerance or inadequate response to methotrexate or other non-biologic DMR...
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DMARD is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied in patients with active rheumatoid arthritis, as part of a controlled clinical trial.
DMARD is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. Roche is conducting clinical research on this investigational therapy for rheumatoid arthritis. The drug is still in clinical development and has not been approved for commercial use.
DMARD is in Phase 3 clinical development for rheumatoid arthritis. This phase typically involves larger studies to confirm efficacy and monitor safety. The drug is investigational and not yet approved. One Phase 3 trial has been completed, with 401 participants enrolled.
DMARD has one completed Phase 3 clinical trial, registered as NCT01995201. The study evaluated subcutaneous RoActemra/Actemra (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis. The trial enrolled 401 participants across Ireland, Portugal, and Spain.
DMARD is a general term for disease-modifying antirheumatic drugs, and the clinical trial NCT01995201 specifically studied tocilizumab, also known as RoActemra/Actemra. The trial evaluated tocilizumab as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis.