Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT02092285
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    50mg or 100mg solution for injection; subcutaneous injection

Study Details

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.

Key Dates

Start date
May 9, 2014
Status verified
Feb 2019
Primary completion
May 25, 2016
Completion
May 25, 2016

Study Design

Enrollment
205 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Golimumab
    The first induction dose of subcutaneous (SC) golimumab 200 mg was administered at Day 0. The second induction dose of SC golimumab 100 mg was administered two weeks later at Week 2. Responders at Week 6 received 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) every 4 weeks during the Maintenance Phase for 48 weeks, yielding a total of 54 weeks treatment.

Primary Outcome Measure

Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54 [ Time Frame: Baseline (Week 0), Week 6, Week 30, Week 54 ]

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