An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Placebo; Golimumab 50 mg; Golimumab 100 mg; Golimumab 200 mg
Intervention description: Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).; Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).; 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.; Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1228.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colitis, Ulcerative; Golimumab; CNTO 148

Summary:

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

Eligibility 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)