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A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Infliximab
Sponsored by
Centocor, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Infliximab, Remicade

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    November 12, 2004
    Last Updated
    May 16, 2011
    Sponsor
    Centocor, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00096655
    Brief Title
    A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis
    Official Title
    A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Centocor, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis
    Keywords
    Ulcerative colitis, Infliximab, Remicade

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    364 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Infliximab
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Centocor, Inc. Clinical Trial
    Organizational Affiliation
    Centocor, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17324131
    Citation
    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. doi: 10.1111/j.1572-0241.2007.01094.x. Epub 2007 Feb 23. Erratum In: Am J Gastroenterol. 2007 Jun;102(6):1338.
    Results Reference
    result
    PubMed Identifier
    17476675
    Citation
    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. doi: 10.1002/ibd.20165.
    Results Reference
    result
    PubMed Identifier
    16339095
    Citation
    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. doi: 10.1056/NEJMoa050516. Erratum In: N Engl J Med. 2006 May 18;354(20):2200.
    Results Reference
    result
    PubMed Identifier
    25173754
    Citation
    Adedokun OJ, Sandborn WJ, Feagan BG, Rutgeerts P, Xu Z, Marano CW, Johanns J, Zhou H, Davis HM, Cornillie F, Reinisch W. Association between serum concentration of infliximab and efficacy in adult patients with ulcerative colitis. Gastroenterology. 2014 Dec;147(6):1296-1307.e5. doi: 10.1053/j.gastro.2014.08.035. Epub 2014 Aug 28.
    Results Reference
    derived
    PubMed Identifier
    21723220
    Citation
    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. doi: 10.1053/j.gastro.2011.06.054. Epub 2011 Jun 30.
    Results Reference
    derived
    PubMed Identifier
    19596014
    Citation
    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. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28.
    Results Reference
    derived
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=151&filename=CR004783_CSR.pdf
    Description
    A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Colitis
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=151&filename=CR004783_REF1.pdf
    Description
    | A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Coliti
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=151&filename=CR004783_REF2.pdf
    Description
    A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Coliti

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    A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis

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