A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Golimumab; Placebo
Intervention description: Participants will receive 200 mg golimumab at Week 0 and 100 mg golimumab at Week 2 as a subcutaneous (SC) (under the skin) injection in the induction phase. Participants who have a clinical response in the induction phase and are randomly allocated to golimumab in the maintenance phase will receive 100 mg SC every 4 weeks through Week 52. Participants who do not have a clinical response in the induction phase will receive 100 mg of golimumab SC at Week 4 and will continue with 100 mg of golimumab SC every 4 weeks through Week 52 only if a response is obtained by Week 8.; Participants who have a clinical response to golimumab in the induction phase and are randomly allocated to placebo in the maintenance phase will receive SC placebo every 4 weeks through Week 52. However, participants receiving placebo and who will lose clinical response any time during the study will be eligible to receive 100 mg golimumab SC every 4 weeks through Week 52.
Intervention MeSH terms: Golimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Japanese; Subcutaneous; Golimumab

Summary:

      The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese
      participants with moderately to severely active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with ulcerative colitis diagnosed prior to screening

          -  Participants should have current treatment for ulcerative colitis with at least one of
             the following therapies: oral 5-aminosalicylates (5-ASAs), oral corticosteroids,
             6-mercaptopurine (6-MP), or azathioprine (AZA)

          -  Participants must have a history of failure to respond to, or tolerate, at least 1 of
             the following therapies: oral 5-ASAs, oral corticosteroids, 6-MP, or AZA

          -  Participants must be ambulatory and have moderately to severely active ulcerative
             colitis confirmed during the screening sigmoidoscopy by a greater than or equal to 2
             using the endoscopy subscore of the Mayo score

          -  Participants must have moderately to severely active ulcerative colitis, defined as a
             baseline Mayo score of 6 to 12, inclusive

        Exclusion Criteria:

          -  Participants with ulcerative colitis limited to the rectum only or to less than 20 cm
             of the colon

          -  Participants with stoma

          -  Participants with fistula or history of fistula

          -  Participants who require, or required within the 2 months prior to screening, surgery
             for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or
             intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions
             possibly confounding the evaluation of benefit from study agent treatment

          -  Participants with symptomatic colonic or small bowel obstruction, confirmed by
             objective radiographic or endoscopic evidence of a stricture with resulting
             obstruction