A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
|ClinicalTrials.gov Identifier: NCT01863771|
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : February 17, 2017
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative||Drug: Golimumab Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Subjects With Moderately to Severely Active Ulcerative Colitis|
|Actual Study Start Date :||March 15, 2013|
|Actual Primary Completion Date :||January 29, 2016|
|Actual Study Completion Date :||January 29, 2016|
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.
|Placebo Comparator: Placebo||
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863771
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|