A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
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
2 other identifiers
interventional
144
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2013
Typical duration for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2013
CompletedFirst Submitted
Initial submission to the registry
May 23, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2016
CompletedResults Posted
Study results publicly available
February 17, 2017
CompletedApril 5, 2017
March 1, 2017
2.9 years
May 23, 2013
October 13, 2016
March 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score
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.
Up to Week 54
Secondary Outcomes (2)
Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54
Weeks 30 and 54
Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54
Weeks 30 and 54
Study Arms (2)
Golimumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Abiko, Japan
Unknown Facility
Chiba, Japan
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Chikushinoshi, Japan
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Fujiidera, Japan
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Fukuoka, Japan
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Fushimi, Japan
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Hamamatsu, Japan
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Hirosaki, Japan
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Hiroshima, Japan
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Ikeda, Japan
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Izumiōtsu, Japan
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Izumo, Japan
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Kagoshima, Japan
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Kahoku, Japan
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Kanazawa, Japan
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Kochi, Japan
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Kurume, Japan
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Maebashi, Japan
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Miyazaki, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Nishinomiya, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Sakura, Japan
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Sapporo, Japan
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Sendai, Japan
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Suita, Japan
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Sunto, Japan
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Tokushima, Japan
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Tokyo, Japan
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Toyota, Japan
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Tsu, Japan
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Tsukuba, Japan
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Wakayama, Japan
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Yokkaichi, Japan
Unknown Facility
Yokohama, Japan
Related Publications (1)
Hibi T, Imai Y, Senoo A, Ohta K, Ukyo Y. Efficacy and safety of golimumab 52-week maintenance therapy in Japanese patients with moderate to severely active ulcerative colitis: a phase 3, double-blind, randomized, placebo-controlled study-(PURSUIT-J study). J Gastroenterol. 2017 Oct;52(10):1101-1111. doi: 10.1007/s00535-017-1326-1. Epub 2017 Mar 21.
PMID: 28324167DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Development
- Organization
- Janssen Pharmaceutical K.K.
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutical K.K., Japan Clinical Trial
Janssen Pharmaceutical K.K.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2013
First Posted
May 29, 2013
Study Start
March 15, 2013
Primary Completion
January 29, 2016
Study Completion
January 29, 2016
Last Updated
April 5, 2017
Results First Posted
February 17, 2017
Record last verified: 2017-03