Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M2591 · 1 trial · 1 indication
ACR20 response: a participant has at least 20% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with 20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); and 5) acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Percentage of participants with ACR20 response using hsCRP = Number of participants with ACR20 response using hsCRP divided by total modified intent-to-treat (mITT) participants \* 100.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| M2951 25 mg QD | EXPERIMENTAL | - |
| M2951 75 mg QD | EXPERIMENTAL | - |
| M2951 50 mg BID | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M2591 25 mg QD | DRUG | Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks. |
| M2951 75 mg QD | DRUG | Participants received 75 mg of M2951 orally QD for 12 weeks. |
| M2951 50 mg BID | DRUG | Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks. |
| Placebo | DRUG | Participants received placebo matched to M2951 orally for 12 weeks. |
Inclusion Criteria: * In Japan, if a participant is less than (\<) 20 years, the written informed consent from the participant's parent or guardian will be required in addition to the participant's written consent. * Confirmed diagnosis of RA according to 2010 ACR/EULAR RA classification criteria o...
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