Phase 3
Completed N=144
A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
Colitis, Ulcerative
Source: ClinicalTrials.gov NCT01863771 ↗
Enrolled (actual)
144
Serious AEs
6.0%
Results posted
Feb 2017
Primary outcomePrimary: Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score — 6; 18 participants
Summary
The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese participants with moderately to severely active ulcerative colitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score |
6; 18 | — |
| SECONDARY Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54 |
2; 16 | — |
| SECONDARY Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54 |
5; 19 | — |
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
Data sourced from ClinicalTrials.gov (NCT01863771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.