Status:
COMPLETED
A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 Description
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 particip...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2016
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01863771
Start Date
March 15 2013
End Date
January 29 2016
Last Update
April 5 2017
Active Locations (38)
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1
Abiko, Japan
2
Chiba, Japan
3
Chikushinoshi, Japan
4
Fujiidera, Japan