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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00488631
• Date of registration: 18/06/2007
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
• Scientific 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
• Date of first enrolment: September 2007
• Target sample size: 1228
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00488631
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Former Serbia and Montenegro, France, Germany, Hungary, India, Israel, Japan, Latvia, Lithuania, Nauru, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Sweden, Ukraine, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Biological: Golimumab 200 mg

Biological: Placebo

Biological: Golimumab 50 mg

Biological: Golimumab 100 mg

Primary Outcome(s)

Number of Participants in Clinical Response Through Week 54 [Time Frame: Induction Baseline, Week 0 through Week 54]

Secondary Outcome(s)

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 Both Week 30 and Week 54 [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]

Number of Participants With Mucosal Healing at Both Week 30 and Week 54 [Time Frame: Week 30 and Week 54]

Secondary ID(s)

CR014179

2006-003399-37

C0524T18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.

Results

• Results available: Yes
• Date Posted: 11/11/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00488631