Clinical Trial: A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subj

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

Detailed Summary: This is a double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (study in which an inactive substance is given to one group of participants, while the study medication is given to another group), multicenter (study conducted at multiple sites), 2-arm (two groups), parallel-group (each group of participants will be treated at the same time), randomized-withdrawal (participants receiving study medication for a specified time will be later randomized to receive either study medication or placebo.) study, including an open-label (all people know the identity of the intervention) induction phase. Approximately 200 participants will participate in this study. This study will consist of an induction phase, a maintenance phase, and a follow-up phase. During the induction phase (lasting 6 weeks) participants will receive 200 mg subcutaneous (SC) (under the skin) golimumab at Week 0 and 100 mg SC golimumab at Week 2. During the maintenance phase (up to Week 52) all participants who show a clinical response (measure of therapeutic effect of study medication) to golimumab during the induction phase will be randomly allocated in a 1:1 ratio to receive either SC administration of placebo (Group 1) or 100 mg golimumab (Group 2) every 4 weeks from Week 0 to Week 52. Participants who do not show clinical response to golimumab will also receive 100 mg SC administration of golimumab until Week 4 and if, by Week 8 of the maintenance phase, these participant's disease activity does not appear to be improving, participants will be discontinued from further study medication administration and will be followed up for safety evaluations 16 weeks after the last administration of study medication. However, if disease activity of these participants improves at Week 8, they will continue to receive golimumab (100 mg every 4 weeks) through Week 52 of the maintenance phase. The follow-up phase will be of 16 weeks duration. During th
Sponsor: Janssen Pharmaceutical K.K.

Current Primary Outcome: Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score [ Time Frame: Up to Week 54 ]

Clinical response was defined as a decrease from Induction-Week 0 in the Mayo score by greater than or equal to (>=) 30 percent and >=3 points, with a decrease in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.


Original Primary Outcome: Number of participants who achieved clinical response measured using the Mayo score [ Time Frame: Up to Week 54 ]

The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.


Current Secondary Outcome:

  • Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54 [ Time Frame: Weeks 30 and 54 ]
    Clinical remission (as measured by the Mayo score) was defined as a Mayo score of less than or equal to (<=) 2 points, with no individual sub-score greater than (>) 1.
  • Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54 [ Time Frame: Weeks 30 and 54 ]
    Mucosal healing is defined as an endoscopy subscore of 0 or 1, where 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern, mild friability). Endoscopy subscore is one of the 4 subscores of the Mayo score.


Original Secondary Outcome:

  • Number of participants who achieved clinical remission (disappearance of clinical characteristics of the disease condition) measured using the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Week 30 and 54 ]
    The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.
  • Number of participants who achieved clinical remission (disappearance of clinical characteristics of the disease condition) using the Euro QOL-5D (EQ-5D) [ Time Frame: Week 30 and 54 ]
    The EQ-5D includes single item measures of: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is coded using 3-levels (1 = no problems; 2 = some problems; 3 = severe problems). The instrument includes a global rating of current health using a visual analog scale (VAS) ranging from 0 (worst imaginable) to 100 (best imaginable).
  • Number of participants who achieved mucosal healing [ Time Frame: Weeks 30 and 54 ]
    Mucosal healing is defined as an endoscopy subscore of 0 or 1, where 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern, mild friability). Endoscopy subscore is one of the 4 subscores of the Mayo score.
  • Number of participants with adverse events. [ Time Frame: Up to 68 Weeks ]


Information By: Janssen Pharmaceutical K.K.

Dates:
Date Received: May 23, 2013
Date Started: March 15, 2013
Date Completion:
Last Updated: March 8, 2017
Last Verified: March 2017