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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01863771
• Date of registration: 23/05/2013
• Prospective Registration: No
• Primary sponsor: Janssen Pharmaceutical K.K.
• Public title: A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
• Scientific 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
• Date of first enrolment: March 15, 2013
• Target sample size: 144
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01863771
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Janssen Pharmaceutical K.K., Japan Clinical Trial
• Affiliation: Janssen Pharmaceutical K.K.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis, Ulcerative

Intervention(s)

Drug: Golimumab

Other: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54 [Time Frame: Weeks 30 and 54]

Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54 [Time Frame: Weeks 30 and 54]

Secondary ID(s)

CNTO148UCO3001

CR100937

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01863771