drugset / Trial / NCT00207727
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis
Timeline
- Start
- 2004-07
- Primary completion
- 2006-03
- Completion
- 2006-08
Outcome
Missed primary endpoint
paper Ustekinumab treatment did not show a significant reduction in the primary endpoint for any dosage groups versus placebo. PMID 18703004 ↗
Publications
- Robinson D Jr, Zhao N, Gathany T, Kim LL, Cella D, Revicki D. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin. 2009 May;25(5):1121-30. doi: 10.1185/03007990902797675.
- Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH; Ustekinumab MS Investigators. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol. 2008 Sep;7(9):796-804. doi: 10.1016/S1474-4422(08)70173-X.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Ustekinumab | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | Ustekinumab | Monoclonal antibody | 200 mg | Subcutaneous |