A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ul… (NCT01551290) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis
China99 participantsStarted 2012-04
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with a clinical response at Week 8