Overview

This trial is active, not recruiting.

Condition colitis, ulcerative
Treatments placebo, golimumab 50 mg, golimumab 100 mg, golimumab 200 mg
Phase phase 3
Sponsor Janssen Research & Development, LLC
Collaborator Merck Sharp & Dohme Corp.
Start date September 2007
End date October 2011
Trial size 1228 participants
Trial identifier NCT00488631, 2006-003399-37, C0524T18, CR014179

Summary

The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
(Experimental)
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.
golimumab 50 mg
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
(Experimental)
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52.
golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
golimumab 200 mg
Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
(Placebo Comparator)
Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
(Experimental)
Participants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
(Experimental)
Participants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
golimumab 100 mg
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.

Primary Outcomes

Measure
Number of Participants in Clinical Response Through Week 54
time frame: Induction Baseline, Week 0 through Week 54

Secondary Outcomes

Measure
Number of Participants With Clinical Remission at Both Week 30 and Week 54
time frame: Week 30 and Week 54
Number of Participants With Mucosal Healing at Both Week 30 and Week 54
time frame: Week 30 and Week 54
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
time frame: Week 30 and Week 54
Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
time frame: Week 54

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) - Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) Exclusion Criteria: - Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) - Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) - Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) - Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C - Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)

Additional Information

Official title A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Description This was a Phase 3, multicenter (conducted in more than one center), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), double-blind (neither the Physician nor the participant know about the study medication), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), randomized-withdrawal study. Participants who were in clinical response to golimumab at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will be randomly assigned in a 1:1:1 ratio at Week 0 of this study to receive 1 of the following maintenance treatment regimens administered subcutaneously every 4 weeks through Week 52: placebo, golimumab 50 mg, or golimumab 100 mg. Participants who were in clinical response to placebo and participants who were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will not be randomly assigned but will be eligible to be enrolled in the study (i.e., the nonrandomized group) and received the following treatment regimens: placebo, golimumab 100 mg and golimumab 100 mg. Dose adjustment will be done for participants who were in clinical response to golimumab or placebo during induction studies C0524T16 (NCT00488774) or C0524T17 (NCT00487539) but lose clinical response during maintenance study C0524T18 (NCT00488631). On completing this study, participant will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years. Efficacy will be primarily evaluated by assessing the clinical response using Mayo Score. Participants' safety will be monitored throughout the study.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Janssen Research & Development, LLC.