A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
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ClinicalTrials.gov Identifier: NCT01551290 |
Recruitment Status
:
Completed
First Posted
: March 12, 2012
Last Update Posted
: October 30, 2015
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Condition or disease | Intervention/treatment | Phase |
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Ulcerative Colitis | Drug: Infliximab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | April 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | October 2014 |

Arm | Intervention/treatment |
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Placebo Comparator: Group I: Placebo
Participants in Group I receive placebo
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Drug: Placebo
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.
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Experimental: Group II: Infliximab
Participants in Group II receive 5 mg/kg infliximab
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Drug: Infliximab
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.
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- Number of participants with a clinical response at Week 8 [ Time Frame: 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.
- Number of participants in clinical remission at Week 8 [ Time Frame: Week 8 ]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.
- Number of participants with mucosal healing at Week 8 [ Time Frame: Week 8 ]Mucosal healing is determined from the endoscopy subscore of the Mayo score. Mucosal healing will be defined by endoscopy subscore of 0 or 1.
- Number of participants with a clinical response at Week 26 [ Time Frame: Week 26 ]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.
- Number of participants in clinical remission at Week 26 [ Time Frame: Week 26 ]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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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551290
China | |
Beijing, China | |
Chengdu, China | |
Guangzhou, China | |
Hefei, China | |
Shanghai, China | |
Wuhan, China | |
Xian, China |
Study Director: | Xian-Janssen Pharmaceutical Ltd. Clinical Trial | Xian-Janssen Pharmaceutical Ltd. |
Additional Information:
Responsible Party: | Xian-Janssen Pharmaceutical Ltd. |
ClinicalTrials.gov Identifier: | NCT01551290 History of Changes |
Other Study ID Numbers: |
CR018769 REMICADEUCO3001 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China ) |
First Posted: | March 12, 2012 Key Record Dates |
Last Update Posted: | October 30, 2015 |
Last Verified: | October 2015 |
Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Ulcerative colitis UC Remicade Infliximab Chinese patients |
Mayo score Mucosal healing Rectal bleeding Inflammatory bowel disease IBD |
Additional relevant MeSH terms:
Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases |
Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases Infliximab Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |