Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DMARDs · 1 trial · 1 indication
Synovitis of the wrist was assessed at three sites including the radioulnar joint (RUJ), the radiocarpal joint (RCJ), and the intercarpal-carpometacarpal joints (IC-CMCJ). Global RAMRIS scores were assigned on a scale of 0 to 3 at each site, where 0 represented normal appearance with no synovial enhancement and each 1-point increase reflected one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. The scores for all three sites were added to give an aggregated score of 0 to 9. Baseline absolute value (AV) and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.
RE was calculated as \[S0 minus (-) S55\] divided by (÷) S0, multiplied by (×) 100 percent (%), where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.
REE per second was calculated as \[S55 - S0\] ÷ \[S0 × 55 seconds\] × 100%, where S0 was defined as the signal noise ratio before contrast injection, and S55 was defined as the signal noise ratio 55 seconds after injection. Signal noise ratios were measured as the ratio between the signal in the region of interest and the standard deviation of background noise. Baseline AV and change from Baseline to Week 4 were averaged among all participants, where negative changes indicated improvement in synovitis.
| Arm | Type | Description |
|---|---|---|
| Tocilizumab in Active RA | EXPERIMENTAL | Participants with active RA will receive tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions will be given from Baseline to Week 44, and participants will be assessed through Week 48. |
| Name | Type | Description |
|---|---|---|
| DMARDs | DRUG | Participants may continue on a stable dose of their current DMARD therapy as prescribed. The choice of DMARD is at the discretion of the treating physician and is not specified by the protocol. |
| Tocilizumab | DRUG | Tocilizumab will be given as 8 mg/kg via IV infusion every 4 weeks for a total of 12 infusions. The maximum allowed dose is 800 mg. |
Inclusion Criteria: * Moderate to severe active RA of ≥6 months duration * DAS28 \>3.2 * Inadequate response to a stable dose of non-biologic DMARD for ≥2 months * Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment Exclusio...
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DMARDs, or disease-modifying anti-rheumatic drugs, are used to treat moderate to severe active rheumatoid arthritis in patients who have had an inadequate response to prior DMARD therapy. They are typically combined with other treatments such as tocilizumab to manage the condition.
DMARDs are developed by Roche Holding AG, a company traded under the ticker RHHBY. The drug is being studied in combination with tocilizumab for the treatment of rheumatoid arthritis.
DMARDs is in Phase 3 clinical development. It is an investigational small molecule being evaluated for rheumatoid arthritis, and it is not yet approved by regulatory authorities.
DMARDs has one completed Phase 3 trial, NCT00996606, which studied tocilizumab in combination with DMARDs in 58 participants with moderate to severe active rheumatoid arthritis who had an inadequate response to DMARDs. The trial was conducted in Italy.
DMARDs are a class of drugs that modify the disease process in rheumatoid arthritis, though the specific molecular target is not detailed. They are used in combination with other therapies to reduce inflammation and slow joint damage.