A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
Information source: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcerative Colitis
Intervention: Infliximab (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Xian-Janssen Pharmaceutical Ltd. Official(s) and/or principal investigator(s): Xian-Janssen Pharmaceutical Ltd. Clinical Trial, Study Director, Affiliation: Xian-Janssen Pharmaceutical Ltd.
Summary
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).
Clinical Details
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of participants with a clinical response at Week 8
Secondary outcome: Number of participants in clinical remission at Week 8Number of participants with mucosal healing at Week 8 Number of participants with a clinical response at Week 26 Number of participants in clinical remission at Week 26
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]).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Beijing, China
Chengdu, China
Guangzhou, China
Hefei, China
Shanghai, China
Wuhan, China
Xian, China
Additional Information
Starting date: April 2012
Last updated: April 13, 2015
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