Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) (GO-COLITIS)
The primary objective of this study is to evaluate the efficacy of golimumab in maintaining a clinical response in participants with moderate-to-severe ulcerative colitis.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis|
- Proportion of Participants Meeting Partial Mayo Score Response Criteria at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
The first dose of subcutaneous (SC) golimumab 200 mg will be administered at Visit 2 (Day 0). The second induction dose of SC golimumab 100 mg will be administered two weeks later at Visit 3 (Week 2). Responders at Visit 4 (Week 6) will receive a maintenance dose of golimumab (50 mg for participants with a body weight <80 kg or 100 mg for participants with a body weight ≥80 kg) during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.
This study consists of a 1 week screening period, a 54 week treatment period, and a 12 week follow-up period, requiring a total of 7 in trial site visits: Visit 1(screening visit, Week -1), Visit 2 (enrollment visit, Day 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 5 (Week 30) and Visit 6 (Week 54) and Visit 7 (follow-up visit, Week 66).
|Contact: Toll Free Number||1-888-577-8839||ClinicalTrialsDisclosure@merck.com|