drugset / Trial / NCT00265122
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
Timeline
- Start
- 2004-04
- Primary completion
- 2005-11
- Completion
- 2006-10
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Population 1: Placebo SC and IV Combined vs Population 1: Ustekinumab SC and IV Combined; p = 0.337 NCT00265122 ↗
paper 49% and 40% (P = .34), respectively at week 8. PMID 18706417 ↗
Publications
- Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.
- Sandborn WJ, Feagan BG, Fedorak RN, Scherl E, Fleisher MR, Katz S, Johanns J, Blank M, Rutgeerts P; Ustekinumab Crohn's Disease Study Group. A randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology. 2008 Oct;135(4):1130-41. doi: 10.1053/j.gastro.2008.07.014. Epub 2008 Jul 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 4.5 mg/kg | Subcutaneous |
| Subject | Ustekinumab | Monoclonal antibody | 90 mg | Subcutaneous |