A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT01551290
• Date of registration: 07/03/2012
• Prospective Registration: Yes
• Primary sponsor: Xian-Janssen Pharmaceutical Ltd.
• Public title: A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
• Scientific 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
• Date of first enrolment: April 2012
• Target sample size: 99
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01551290
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Xian-Janssen Pharmaceutical Ltd. Clinical Trial
• Affiliation: Xian-Janssen Pharmaceutical Ltd.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: Infliximab

Primary Outcome(s)

Number of participants with a clinical response at Week 8 [Time Frame: Week 8]

Secondary Outcome(s)

Number of participants with a clinical response at Week 26 [Time Frame: Week 26]

Number of participants with mucosal healing at Week 8 [Time Frame: Week 8]

Number of participants in clinical remission at Week 26 [Time Frame: Week 26]

Number of participants in clinical remission at Week 8 [Time Frame: Week 8]

Secondary ID(s)

CR018769

REMICADEUCO3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors