- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551290
A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
October 28, 2015 updated by: Xian-Janssen Pharmaceutical Ltd.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of infliximab in Chinese patients with active ulcerative colitis (swelling and ulceration of large intestine and rectum).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), placebo controlled (placebo is an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), double blind (neither investigator nor patient knows the treatment that the patient receives), 2-arm (2 groups), parallel group (a clinical study comparing the response in two or more groups of participants receiving different treatments) study with infliximab in patients with active ulcerative colitis.
The study consists of screening period (4 weeks prior to baseline [patient's medical status before any treatment or research is done] at Week 0), treatment period (Week 0 to Week 22) and follow up period (Week 26).
Participants completing treatment till Week 22 and benefit from continued treatment (in the opinion of the investigator) may enter a study extension period from Week 30 until Week 58.
Hundred participants will be randomized to 2 groups: Group 1 (50 participants receiving placebo) and Group 2 (50 participants receiving infliximab).
Effectiveness and safety (physical examination, and a review of AEs, vital signs, laboratory analyses, and concomitant medications) will be evaluated at Week 8 and Week 26 and at Week 58 (for participants who enter extension phase).
The maximum duration for participants in the main study is 26 weeks.
The maximum duration for participants including study extension is 58 weeks.
One of the specialized procedures used to calculate efficacy will be Mayo score which is calculated using the subscore (recorded in Mayo Diary Card by each participant) of the following 4 variables (1) stool frequency (scores ranging from 0 [normal number stools for this patient] to 3 [5 or more stools more than normal]), (2) rectal bleeding (scores ranging from 0 [no blood seen] to 3 [blood alone passed]), (3) endoscopic findings (scores ranging from 0 [normal or inactive disease] to 3 [severe disease ie, spontaneous bleeding and ulceration]), and (4) the physician's global assessment (scores ranging from 0 [normal] to 3 [severe disease]).
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China
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Chengdu, China
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Guangzhou, China
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Hefei, China
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Shanghai, China
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Wuhan, China
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Xian, China
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has active ulcerative colitis of at least 3 months duration at screening with score of ≥2 on the endoscopy subscore of the Mayo score and baseline Mayo score of 6 to 12
- Concomitant medications: either have concurrent treatment with at least 1 of the therapies (eg, oral corticosteroids and 6-Mercaptopurine [6-MP]).
- Has to be eligible according to the tuberculosis (TB) eligibility assessment
Exclusion Criteria:
- Has severe extensive colitis or ulcerative colitis limited to only the rectum or to less than 20 cm of the colon
- Requires or required within 2 months prior to screening any surgery for active gastrointestinal bleeding, peritonitis (inflammation of abdominal lining), intestinal obstruction, or intra-abdominal or pancreatic abscess (a localized collection of pus in pancreas) requiring surgical drainage -Has severe fixed symptomatic stenosis (narrowing of the opening or hollow of any passage) of large or small intestine
- Has colonic obstruction or history within the 6 months prior to baseline
- Has colonic mucosal dysplasia (colonic mucosal cell maturation abnormality) or its history
- Has a history of extensive colonic resection (extensive partial removal of colon), lymphoproliferative disease (disease in which lymphocytes are produced in excessive quantities), demyelinating disease (disease of the nervous system)
- Has adenomatous colonic polyps (benign projecting mass of large intestine), stoma (opening either natural or surgically created connecting a portion of the body cavity to the outside environment), known infection of Human immunodeficiency virus (HIV), hepatitis B and C
- Has had treatment with cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group I: Placebo
Participants in Group I receive placebo
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Form = solution for injection, route = IV, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with placebo through Week 22 will receive infliximab at Weeks 32, 34, 38, 46 and 54 and will receive placebo at Week 30.
|
Experimental: Group II: Infliximab
Participants in Group II receive 5 mg/kg infliximab
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Form = solution for injection, route = intravenous (IV), Unit = mg/kg, number = 5, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with infliximab through Week 22 will receive infliximab at Weeks 30, 38, 46 and 54, and will receive placebo at Week 32 and 34.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with a clinical response at Week 8
Time Frame: Week 8
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At Week 8, clinical response is defined as a decrease from baseline (closest measurement taken prior to or at the time of the initiation of the baseline [Week 0] infusion) in the Mayo score by ≥30% and ≥3 points, with a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1, at Week 8.
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Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants in clinical remission at Week 8
Time Frame: Week 8
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A clinical remission at Week 8 is defined as a Mayo score ≤2 points, with no individual subscore >1.
Participants in remission by this definition will have rectal bleeding subscore of either 0 or 1.
|
Week 8
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Number of participants with mucosal healing at Week 8
Time Frame: Week 8
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Mucosal healing is determined from the endoscopy subscore of the Mayo score.
Mucosal healing will be defined by endoscopy subscore of 0 or 1.
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Week 8
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Number of participants with a clinical response at Week 26
Time Frame: Week 26
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At Week 26, clinical response is defined as decrease from baseline in the Mayo score by ≥30% and ≥3 points, with a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1, at Week 26.
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Week 26
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Number of participants in clinical remission at Week 26
Time Frame: Week 26
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A clinical remission at Week 26 is defined as a Mayo score ≤2 points, with no individual subscore >1.
Participants in remission by this definition will have rectal bleeding subscore of either 0 or 1.
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Week 26
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
March 7, 2012
First Submitted That Met QC Criteria
March 7, 2012
First Posted (Estimate)
March 12, 2012
Study Record Updates
Last Update Posted (Estimate)
October 30, 2015
Last Update Submitted That Met QC Criteria
October 28, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR018769
- REMICADEUCO3001 (Other Identifier: Xian-Janssen Pharmaceutical Ltd., China)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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