Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Standard DMARDs (Disease Modifying Anti Rheumatic Drugs), DMARDs
Standard 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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Standard DMARDs stands for Disease Modifying Anti Rheumatic Drugs, a class of small molecule therapies used in immunology. In this program, Roche Holding AG studied standard DMARDs as background therapy in rheumatoid arthritis. The Phase 3 trial NCT00996606 evaluated tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis.
Standard DMARDs are used in rheumatoid arthritis as disease modifying anti rheumatic drugs. In the Phase 3 study NCT00996606, they were given as background therapy alongside tocilizumab in participants with moderate to severe active rheumatoid arthritis who had an inadequate response to DMARDs. The trial enrolled 58 participants in Italy.
Roche Holding AG, which trades under the ticker RHHBY, is the developer associated with this Standard DMARDs program. Roche sponsored the Phase 3 trial NCT00996606 evaluating tocilizumab in combination with disease modifying anti rheumatic drugs in rheumatoid arthritis.
Standard DMARDs in this program are at Phase 3. The single listed trial, NCT00996606, is a completed Phase 3 study of tocilizumab in combination with disease modifying anti rheumatic drugs in participants with moderate to severe active rheumatoid arthritis. It is investigational and not approved.
One clinical trial is listed: NCT00996606, titled A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs. It is a completed Phase 3 study with 58 participants in Italy.
Yes. Standard DMARDs is also known as Disease Modifying Anti Rheumatic Drugs, or DMARDs. The full term and the abbreviation refer to the same drug class used in rheumatoid arthritis, including in the Phase 3 trial NCT00996606 of tocilizumab plus DMARDs.