drugset / Trial / NCT00488631
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Phase 3
Completed
1228 enrolled
Janssen Research & Development, LLC
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
Timeline
- Start
- 2007-09
- Primary completion
- 2011-10
- Completion
- 2015-02
Outcome
Met primary endpoint
paper 31.2% of patients receiving placebo (P = .010 and P < .001, respectively). PMID 23770005 ↗
registry Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance vs GLM-I-Rsp-Golimumab 50 mg Maintenance; p = 0.010; NCT00488631 ↗
registry Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance vs GLM-I-Rsp-Golimumab 100 mg Maintenance; p <0.001; NCT00488631 ↗
Publications
- Weinstein CLJ, Meehan AG, Govoni M, Lin J, Reinisch W. Low Occurrence of Colectomy With Long-Term (up to 4 Years) Golimumab Treatment in Patients With Moderate-to-Severe Active Ulcerative Colitis: Data From the PURSUIT Maintenance and Long-Term Extension Studies. Crohns Colitis 360. 2023 Aug 26;5(3):otad044. doi: 10.1093/crocol/otad044. eCollection 2023 Jul.
- Perrig K, Krupka N, Jordi SBU, Rossel JB, Biedermann L, Greuter T, Schreiner P, Vavricka SR, Juillerat P, Burri E, Zimmermann D, Maillard MH, Sulz MC, Brand S, Rogler G, Misselwitz B. Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland. Ther Adv Gastroenterol. 2022 Feb 9;15:17562848221074188. doi: 10.1177/17562848221074188. eCollection 2022.
- 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.
- Philip G, Cornillie F, Adedokun JO, Melsheimer R, Rutgeerts P, Colombel JF, Marano C. Early Dose Optimisation of Golimumab in Nonresponders to Induction Treatment for Ulcerative Colitis Is Effective and Supported by Pharmacokinetic Data. J Crohns Colitis. 2019 Sep 27;13(10):1257-1264. doi: 10.1093/ecco-jcc/jjz052.
- Reinisch W, Gibson PR, Sandborn WJ, Feagan BG, Strauss R, Johanns J, Padgett L, Adedokun OJ, Colombel JF, Collins J, Rutgeerts P, Tarabar D, Marano C. Long-Term Benefit of Golimumab for Patients with Moderately to Severely Active Ulcerative Colitis: Results from the PURSUIT-Maintenance Extension. J Crohns Colitis. 2018 Aug 29;12(9):1053-1066. doi: 10.1093/ecco-jcc/jjy079.
- 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, Rutgeerts P; PURSUIT-Maintenance Study Group. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14.
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 |