An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Golimumab 4 mg per kg; Drug: Golimumab 2 mg per kg; Other: Placebo; Drug: Golimumab 1 mg per kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488774

C0524T16 (Other Identifier)

CR014188

2006-003397-94 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

Full description

This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions [treatments]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC. At Week 6, participants will be asked to participate in an additional 1-year maintenance study. Participants not entering the 1-year golimumab maintenance study will be evaluated for safety at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging" portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity). Participants' safety and quality of life will also be monitored throughout the study.

Enrollment: 291 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
• Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
• Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and azathioprine (AZA)
• Participants with current dependency or with a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC) - Not have a diagnosis of active TB

Exclusion criteria

• Participants with previous exposure to biologic anti-tumor necrosis factor (TNF) agents
• Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
• Participants having UC limited to the rectum only or to less than 20 centimeter (cm) of the colon
• Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
• Participants with a history of extensive colonic resection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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291 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0

Treatment:

Other: Placebo

Golimumab 1 milligram (mg) per kilogram (kg)

Experimental group

Description:

Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.

Treatment:

Drug: Golimumab 1 mg per kg

Golimumab 2 mg per kg

Experimental group

Description:

Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.

Treatment:

Drug: Golimumab 2 mg per kg

Golimumab 4 mg per kg

Experimental group

Description:

Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.

Treatment:

Drug: Golimumab 4 mg per kg