drugset / Trial / NCT00267956
An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
RandomizedCrossoverQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.
Timeline
- Start
- 2005-12
- Primary completion
- 2007-03
- Completion
- 2007-09
Outcome
Met primary endpoint
paper At week 12, 32 (42%) patients in Group 1 and ten (14%) in Group 2 achieved the primary endpoint (difference 28% [95% CI 14.0-41.6]; p=0.0002). PMID 19217154 ↗
registry analysis (superiority or other test); Group I: Placebo vs Group II: Ustekinumab x 4; p <0.001; Cochran-Mantel-Haenszel (CMH) chi-square; NCT00267956 ↗
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.
- Gottlieb A, Menter A, Mendelsohn A, Shen YK, Li S, Guzzo C, Fretzin S, Kunynetz R, Kavanaugh A. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. 2009 Feb 21;373(9664):633-40. doi: 10.1016/S0140-6736(09)60140-9. Epub 2009 Feb 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ustekinumab | Monoclonal antibody | 63 mg | Subcutaneous |