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

NCT01551290 | Completed Phase 3

• 2 other identifiers: CR018769REMICADEUCO3001
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; UC; Remicade; Infliximab; Chinese patients; Mayo score; Mucosal healing; Rectal bleeding; Inflammatory bowel disease; IBD

Outcome Measures

Primary Outcomes (1)

• Number of participants with a clinical response at Week 8

  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.

  Week 8

Secondary Outcomes (4)

• Number of participants in clinical remission at Week 8

  Week 8

• Number of participants with mucosal healing at Week 8

  Week 8

• Number of participants with a clinical response at Week 26

  Week 26

• Number of participants in clinical remission at Week 26

  Week 26

Study Arms (2)

Group I: Placebo

PLACEBO COMPARATOR

Participants in Group I receive placebo

Drug: Placebo

Group II: Infliximab

EXPERIMENTAL

Participants in Group II receive 5 mg/kg infliximab

Drug: Infliximab

Interventions

Infliximab DRUG

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.

Group II: Infliximab

Placebo DRUG

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.

Group I: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (7)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hefei, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

Xi'an, China

Location

Related Links

• A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis

MeSH Terms

Conditions

Colitis, Ulcerative; Gastrointestinal Hemorrhage; Inflammatory Bowel Diseases

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xian-Janssen Pharmaceutical Ltd. Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

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: March 7, 2012
• First Posted: March 12, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

CN (7)