drugset / Trial / NCT00487539
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Phase 2/3
Completed
1065 enrolled
Janssen Research & Development, LLC
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
Timeline
- Start
- 2007-08
- Primary completion
- 2010-10
- Completion
- 2010-10
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Golimumab 200 mg -> 100 mg; p <0.0001; Chi-squared NCT00487539 ↗
registry analysis (superiority or other test); Placebo vs Golimumab 400 mg -> 200 mg; p <0.0001; Chi-squared NCT00487539 ↗
paper In phase 3, rates of clinical response at week 6 were 51.0% and 54.9% among patients given 200 mg/100 mg and 400 mg/200 mg golimumab, respectively, vs 30.3% among those given placebo (both, P ≤ .0001). PMID 23735746 ↗
Publications
- Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.
- Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.
- Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 200 mg | Subcutaneous |