| November 12, 2004 |
| August 21, 2008 |
| May 2002 |
| |
| 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 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 |
| Complete list of historical versions of study NCT00096655 on ClinicalTrials.gov Archive Site |
| Achievement of clinical remission defined as a Mayo score of = 2 points, with no individual subscore > 1 at week ,Patients in remission will have a rectalbleeding subscore of either 0 or 1, patients who demonstrate mucosal healing at week 8. |
- The proportion of patients in clinical remission defined as a Mayo score of ≤ 2 points, with noindividual subscore > 1 at week 8
- Patients in remission by this definition will have a rectalbleeding subscore of either 0 or 1
- The proportion of patients who demonstrate mucosal healing at week 8
|
| |
| A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis |
| A Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis |
The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease. |
This study is designed to investigate the safety and effectiveness of infliximab 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 5 or 10 mg/kg or placebo at weeks 0, 2, 6, 14, and 22 up to week 164. 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 (into the vein) of either 5 or 10 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks up to week 164. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Ulcerative Colitis |
| Drug: Infliximab |
| |
- Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76.
- Reinisch W, Sandborn WJ, Bala M, Yan S, Feagan BG, Rutgeerts P, Radford-Smith G, Xu S, Eisenberg D, Olson A, Colombel JF. Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis. Inflamm Bowel Dis. 2007 Sep;13(9):1135-40.
- Feagan BG, Reinisch W, Rutgeerts P, Sandborn WJ, Yan S, Eisenberg D, Bala M, Johanns J, Olson A, Hanauer SB. The effects of infliximab therapy on health-related quality of life in ulcerative colitis patients. Am J Gastroenterol. 2007 Apr;102(4):794-802. Epub 2007 Feb 23. Erratum in: Am J Gastroenterol. 2007 Jun;102(6):1338.
- Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. Epub 2009 Jul 28.
|
| |
| Completed |
| 360 |
| August 2007 |
|
Inclusion Criteria:
- Patients must have had ulcerative colitis of at least 3 months' duration at screening, confirmed by the biopsy taken at screening
- Patients must have active colitis confirmed during the screening sigmoidoscopy
- Patients must have active disease
Exclusion Criteria:
- Patient must not be likely to require surgical removal of all or part of the colon within 12 weeks of beginning the study
- Patient 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
|
| Both |
| 18 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00096655 |
|
| CR004783 |
| Centocor, Inc. |
|
| Study Director: |
Centocor, Inc. Clinical Trial |
Centocor, Inc. |
|
|
| Centocor, Inc. |
| August 2008 |
