Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atacicept · 1 trial · 1 indication
ACR20-CRP response is defined as greater than or equal to (\>=) 20 percent (%) 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 5 measures: 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; and 5) acute-phase marker (CRP).
| Arm | Type | Description |
|---|---|---|
| Atacicept 25 mg | EXPERIMENTAL | - |
| Atacicept 75 mg | EXPERIMENTAL | - |
| Atacicept 150 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Atacicept | DRUG | Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks. |
| Placebo matched to atacicept | DRUG | Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks. |
Inclusion Criteria: 1. Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic criteria with a disease history of at least one year 2. Male or female greater than or equal to (\>=)18-years of age at time of informed consent 3. Active RA as defined by: * \>=8 swoll...
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Atacicept is an investigational small molecule being studied for the treatment of rheumatoid arthritis, an autoimmune disease that causes joint inflammation and pain. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Atacicept is being developed by Merck KGaA, a multinational pharmaceutical company. The company's stock is traded over-the-counter under the ticker MKGAF. The drug is currently in Phase 2 clinical trials for rheumatoid arthritis.
Atacicept is in Phase 2 clinical development. It has completed one Phase 2 trial for rheumatoid arthritis, and the drug remains investigational, meaning it has not been approved for commercial use.
Atacicept has been studied in a Phase 2 dose-finding trial, identified as NCT00430495, titled "A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)." This trial enrolled 256 participants and was conducted in the United States and Canada.
No, AUGUST I is the name of a clinical trial, not an alternative name for Atacicept. The trial, with identifier NCT00430495, was a Phase 2 dose-finding study of Atacicept in subjects with rheumatoid arthritis.