drugset / Trial / NCT01010581
SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267 (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the treatment of patients suffering from Rheumatoid Arthritis.
Timeline
- Start
- 2009-11
- Primary completion
- 2011-04
- Completion
- 2011-07
Outcome
Missed primary endpoint
paper ACR20) responder rate at 13 weeks, demonstrated numerical superiority in the treatment group compared with placebo; however, it did not reach statistical significance. PMID 31621054 ↗
Publications
- Muehler A, Kohlhof H, Groeppel M, Vitt D. The Selective Oral Immunomodulator Vidofludimus in Patients with Active Rheumatoid Arthritis: Safety Results from the COMPONENT Study. Drugs R D. 2019 Dec;19(4):351-366. doi: 10.1007/s40268-019-00286-z.
- Kulkarni OP, Sayyed SG, Kantner C, Ryu M, Schnurr M, Sardy M, Leban J, Jankowsky R, Ammendola A, Doblhofer R, Anders HJ. 4SC-101, a novel small molecule dihydroorotate dehydrogenase inhibitor, suppresses systemic lupus erythematosus in MRL-(Fas)lpr mice. Am J Pathol. 2010 Jun;176(6):2840-7. doi: 10.2353/ajpath.2010.091227. Epub 2010 Apr 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | — | Oral |
| Subject | Vidofludimus | Small molecule | 35 mg | Oral |
| Background | folic acid | Other / unclassified | — | Oral |