An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Colitis, Ulcerative

Treatments: Biological: Golimumab 50 mg; Biological: Golimumab 200 mg; Biological: Golimumab 100 mg; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488631

C0524T18 (Other Identifier)

2006-003399-37 (EudraCT Number)

CR014179

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,228 participants in 6 patient groups, including a placebo group

Golimumab induction responders (GLM-I-Rsp)-Placebo Maintenance

Placebo Comparator group

Description:

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.

Treatment:

Biological: Golimumab 100 mg

Biological: Placebo

GLM-I-Rsp-Golimumab 50 mg Maintenance

Experimental group

Description:

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.

Treatment:

Biological: Golimumab 50 mg

Biological: Golimumab 100 mg

GLM-I-Rsp-Golimumab 100 mg Maintenance

Experimental group

Description:

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.

Treatment:

Biological: Golimumab 100 mg

Biological: Golimumab 200 mg

Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance

Placebo Comparator group

Description:

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.

Treatment:

Biological: Golimumab 100 mg

Biological: Placebo

PBO-I-nonRsp-Golimumab 100 mg Maintenance

Experimental group

Description:

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.

Treatment:

Biological: Golimumab 100 mg

GLM-I-nonRsp-Golimumab 100 mg Maintenance

Experimental group

Description:

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.

Treatment:

Biological: Golimumab 100 mg