A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis - Full Text View

Sponsor:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00096655

Purpose

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.

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Infliximab	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Infliximab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

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 .

Secondary Outcome Measures:

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 rectal bleeding subscore of either 0 or 1, patients who demonstrate mucosal healing at week 8.

Enrollment:	364
Study Start Date:	May 2002
Study Completion Date:	August 2007

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096655

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Additional Information:

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Colitis This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

/ A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Coliti This link exits the ClinicalTrials.gov site

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Coliti This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Colombel JF, Rutgeerts P, Reinisch W, Esser D, Wang Y, Lang Y, Marano CW, Strauss R, Oddens BJ, Feagan BG, Hanauer SB, Lichtenstein GR, Present D, Sands BE, Sandborn WJ. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology. 2011 Oct;141(4):1194-201. Epub 2011 Jun 30.

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.

ClinicalTrials.gov Identifier:	NCT00096655 History of Changes
Other Study ID Numbers:	CR004783
Study First Received:	November 12, 2004
Last Updated:	May 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Ulcerative colitis
Infliximab
Remicade

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases

Pathologic Processes
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012