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IR Prednisone · 1 trial · 1 indication
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
| Arm | Type | Description |
|---|---|---|
| MR Prednisone | EXPERIMENTAL | Participants will receive MR prednisone at bed time and placebo matching to IR prednisone in the morning. Total duration of double blind treatment will be 12 weeks. |
| IR Prednisone | ACTIVE_COMPARATOR | Participants will receive IR prednisone in the morning and placebo matching to MR prednisone at bed time. Total duration of double blind treatment will be 12 weeks. |
| Name | Type | Description |
|---|---|---|
| MR Prednisone | DRUG | Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams \[mg\] prednisone per day) at bed time. |
| IR Prednisone | DRUG | Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning. |
| Placebo - MR Prednisone | DRUG | Participants will receive placebo matching to MR prednisone tablet at bed time. |
| Placebo - IR Prednisone | DRUG | Participants will receive placebo matching to IR prednisone tablet in the morning. |
Inclusion Criteria: * Active disease (inflammatory signs, erythrocyte sedimentation rate \[ESR\], C-reactive protein \[CRP\]) * Stable condition * Stable basic treatments * Morning stiffness on previous treatment with standard prednisone (below or equal to 10 mg per day) greater than or equal to (\...
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IR Prednisone is an immediate-release formulation of prednisone, a corticosteroid, being studied for the treatment of rheumatoid arthritis. It is an investigational small molecule in Phase 3 clinical development. The drug is being evaluated in patients with rheumatoid arthritis to assess its efficacy and safety compared to a modified-release formulation.
IR Prednisone is being developed by Merck KGaA, a science and technology company. The company's stock is traded under the ticker MKGAF. Merck KGaA is conducting clinical trials to evaluate the safety and efficacy of IR Prednisone in patients with rheumatoid arthritis.
IR Prednisone is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for the treatment of rheumatoid arthritis.
IR Prednisone has one completed Phase 3 clinical trial, identified as NCT00146640. This randomized, double-blind, active-controlled study compared a modified-release formulation of prednisone to standard immediate-release prednisone in 288 participants with rheumatoid arthritis. The trial was conducted in Germany and Poland.
No, IR Prednisone is the immediate-release formulation of prednisone, while the clinical trial NCT00146640 compared it to a modified-release formulation. The study was designed to evaluate the modified-release tablet against the standard immediate-release version in participants with rheumatoid arthritis.