drugset / Trial / NCT03001219
A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.
Timeline
- Start
- 2016-12-22
- Primary completion
- 2018-11-06
- Completion
- 2018-11-06
Outcome
Outcome not reported
Stopped: “The trial was prematurely terminated due to a lack of efficacy of the investigational drug.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RO7123520 | Unknown | — | Intravenous |
| Background | Methotrexate | Small molecule | — | — |