Clinical trial NCT01863771: A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: Ulcerative Colitis
Japanese
Subcutaneous
Golimumab
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 participants, while the study medication is given to another group), multicenter (study conducted at multiple sites), 2-arm (two groups), parallel-group (each group of participants will be treated at the same time), randomized-withdrawal (participants receiving study medication for a specified time will be later randomized to receive either study medication or placebo.) study, including an open-label (all people know the identity of the intervention) induction phase. Approximately 200 participants will participate in this study. This study will consist of an induction phase, a maintenance phase, and a follow-up phase. During the induction phase (lasting 6 weeks) participants will receive 200 mg subcutaneous (SC) (under the skin) golimumab at Week 0 and 100 mg SC golimumab at Week 2. During the maintenance phase (up to Week 52) all participants who show a clinical response (measure of therapeutic effect of study medication) to golimumab during the induction phase will be randomly allocated in a 1:1 ratio to receive either SC administration of placebo (Group 1) or 100 mg golimumab (Group 2) every 4 weeks from Week 0 to Week 52. Participants who do not show clinical response to golimumab will also receive 100 mg SC administration of golimumab until Week 4 and if, by Week 8 of the maintenance phase, these participant's disease activity does not appear to be improving, participants will be discontinued from further study medication administration and will be followed up for safety evaluations 16 weeks after the last administration of study medication. However, if disease activity of these participants improves at Week 8, they will continue to receive golimumab (100 mg every 4 weeks) through Week 52 of the maintenance phase. The follow-up phase will be of 16 weeks duration. During this study, any participant who have a clinical response during the induction phase but lose clinical response at any time will be eligible for dose adjustment only once as follows: 1) participants receiving placebo (Group 1) will receive golimumab 100 mg; 2) participants receiving golimumab 100 mg (Group 2) will continue to receive golimumab 100 mg. Safety evaluations will include assessment of adverse events, laboratory measurements, antinuclear antibodies/anti-double-stranded deoxyribonucleic acid antibodies, and vital signs. The maximum study duration for a participant will be 68 weeks.

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

Primary outcomes:
measure: Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score
timeFrame: Up to Week 54
Secondary outcomes:
measure: Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54
timeFrame: Weeks 30 and 54
measure: Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54
timeFrame: Weeks 30 and 54
Other outcomes:
Locations:
city: Abiko
country: Japan
city: Chiba
country: Japan
city: Chikushinoshi
country: Japan
city: Fujiidera
country: Japan
city: Fukuoka
country: Japan
city: Fushimi
country: Japan
city: Hamamatsu
country: Japan
city: Hirosaki
country: Japan
city: Hiroshima
country: Japan
city: Ikeda
country: Japan
city: Izumiotsu
country: Japan
city: Izumo
country: Japan
city: Kagoshima
country: Japan
city: Kahoku
country: Japan
city: Kanazawa
country: Japan
city: Kochi
country: Japan
city: Kurume
country: Japan
city: Maebashi
country: Japan
city: Miyazaki
country: Japan
city: Nagasaki
country: Japan
city: Nagoya
country: Japan
city: Nishinomiya
country: Japan
city: Oita
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Sakura
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Suita
country: Japan
city: Sunto
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Toyota
country: Japan
city: Tsukuba
country: Japan
city: Tsu
country: Japan
city: Wakayama
country: Japan
city: Yokkaichi
country: Japan
city: Yokohama
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.