Overview

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

Status:
Completed
Trial end date:
2016-01-29
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese participants with moderately to severely active ulcerative colitis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutical K.K.
Treatments:
Antibodies, Monoclonal
Golimumab
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