drugset / Trial / NCT00488774
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
Phase 2/3
Terminated
291 enrolled
Janssen Research & Development, LLC
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
Timeline
- Start
- 2007-08
- Primary completion
- 2009-05
- Completion
- 2009-05
Outcome
Missed primary endpoint
Stopped: “Protocol was cancelled by company based on overall efficacy, no safety concern”
registry analysis (superiority or other test); Placebo vs Golimumab 1 mg Per kg; p = 0.467; Chi-squared NCT00488774 ↗
registry analysis (superiority or other test); Placebo vs Golimumab 2 mg Per kg; p = 0.081; Chi-squared NCT00488774 ↗
registry analysis (superiority or other test); Placebo vs Golimumab 4 mg Per kg; p = 0.145; Chi-squared NCT00488774 ↗
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.
- Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Golimumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Golimumab | Monoclonal antibody | 4 mg/kg | Intravenous |