A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT00036439 |
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Recruitment Status :
Completed
First Posted : May 13, 2002
Last Update Posted : May 17, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: Infliximab | Phase 3 |
This is a study designed to investigate the safety and effectiveness of a medication called infliximab (the active drug in (REMICADE®) in adult patients with active ulcerative colitis. The purpose of this study is to see if the symptoms of ulcerative colitis are lessened with this medication, infliximab, and what dose is needed to do that safely. Patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years.
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive infusions of either 5mg/kg, 10 mg/kg or placebo at weeks 0, 2, 6, and then once every 8 weeks thereafter through week 46 for up to 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 364 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis |
| Study Start Date : | February 2002 |
| Actual Study Completion Date : | January 2007 |
- The proportion of patients with clinical response, defined as a 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 8.
- The proportion of patients in clinical remission defined as a Mayo score of = 2 points, with no individual subscore > 1 at week 8; Patients in remission by this definition will have a rectal bleeding subscore of either 0 or 1; mucosal heeling at week 8
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who have had ulcerative colitis of at least 3 months' duration at screening
- Patients who have ulcerative colitis confirmed by the biopsy taken at screening
- Patients must have active colitis confirmed during the screening sigmoidoscopy
- Patients must have active disease.
Exclusion Criteria:
- Patients must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
- Patients must not require, or required within the 2 months prior to beginning the study, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage
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): NCT00036439
| Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00036439 |
| Other Study ID Numbers: |
CR004777 |
| First Posted: | May 13, 2002 Key Record Dates |
| Last Update Posted: | May 17, 2011 |
| Last Verified: | March 2010 |
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ulcerative colitis infliximab Remicade infusion |
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases |
Pathologic Processes Inflammatory Bowel Diseases Infliximab Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |