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Care Path for the Management of Ulcerative Colitis (CONSTRUCT)

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Enhanced treatment algorithm
Usual Care
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring CONSTRUCT, Cluster randomization controlled trial, Gastroenterology practices in North America

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records -- - Documented diagnosis of UC with a Mayo Clinic Score (MCS) ≥6 and a baseline Mayo Endoscopy Score >2.
  • Either an elevated serum C-reactive protein (CRP) (above the Upper Level of Normal (ULN) according to local laboratory results) or elevated fecal calprotectin (> 250 mg/kg) concentration.
  • Requires sigmoidoscopic evaluation at baseline (standard of care)
  • Written informed consent must be obtained and documented.
  • Ability of subject to participate fully in all aspects of this clinical trial in the opinion of the investigator.

Exclusion Criteria:

  • Previous failure of TNF antagonist therapy
  • Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
  • Pregnant or lactating women.
  • Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator, may interfere with the subject's ability to comply with study procedures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Enhanced treatment algorithm

    Usual Care

    Arm Description

    Treatment algorithm featuring the early use of combination therapy, treatment intensification guided by objective assessments of inflammation and the use of remission as a therapeutic goal

    These subjects will be managed according to local treatment guidelines for the treatment of UC.

    Outcomes

    Primary Outcome Measures

    Proportion of patients in remission at the end of 12 months.
    Remission is defined as 1) a Mayo Clinic Score of ≤2 with rectal bleeding and stool frequency sub-scale scores of 0) with no use of corticosteroids, and 3) normalization of the subject's index inflammatory marker (c-reactive protein or calprotectin). The primary endpoint will be assessed at Month 12.

    Secondary Outcome Measures

    Proportion of patients in remission over the course of the study
    The time in remission over the course of the study; occurrence of surgery or hospitalization for Ulcerative Colitis; occurrence of disease-related complications; health related QoL (Short-Form 36 questionnaire [SF-36] and EuroQoL instrument [EQ-5D]); and, subject

    Full Information

    First Posted
    June 17, 2013
    Last Updated
    May 12, 2016
    Sponsor
    University of Western Ontario, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01882426
    Brief Title
    Care Path for the Management of Ulcerative Colitis
    Acronym
    CONSTRUCT
    Official Title
    A Cluster Randomized Controlled Trial of a Care-Path for the Management of Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Terminated
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    May 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Western Ontario, Canada

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Assess if standardized care-path that features objective evaluations of disease activity and time-bound algorithms is superior to usual step-care in the treatment of ulcerative colitis.
    Detailed Description
    Step-care based on symptomatic response remains the overwhelming algorithm of choice in clinical practice. Many subjects receive infliximab only as a last resort, when the subject is very ill and has failed repeated attempts of corticosteroid induction therapy. Although this situation is far from ideal, to change such entrenched physician behavior will require compelling evidence that Step-care results in inferior outcomes to earlier introduction of effective therapy. Based on these considerations, we will perform a cluster randomization trial in which 40 gastroenterology practices will be randomly assigned to a treatment algorithm featuring the early use of combination therapy, treatment intensification guided by objective assessments of inflammation and the use of remission as a therapeutic goal or a conventional Step-care approach.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis
    Keywords
    CONSTRUCT, Cluster randomization controlled trial, Gastroenterology practices in North America

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    192 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhanced treatment algorithm
    Arm Type
    Active Comparator
    Arm Description
    Treatment algorithm featuring the early use of combination therapy, treatment intensification guided by objective assessments of inflammation and the use of remission as a therapeutic goal
    Arm Title
    Usual Care
    Arm Type
    Placebo Comparator
    Arm Description
    These subjects will be managed according to local treatment guidelines for the treatment of UC.
    Intervention Type
    Other
    Intervention Name(s)
    Enhanced treatment algorithm
    Intervention Description
    Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Intervention Description
    usual step care practice
    Primary Outcome Measure Information:
    Title
    Proportion of patients in remission at the end of 12 months.
    Description
    Remission is defined as 1) a Mayo Clinic Score of ≤2 with rectal bleeding and stool frequency sub-scale scores of 0) with no use of corticosteroids, and 3) normalization of the subject's index inflammatory marker (c-reactive protein or calprotectin). The primary endpoint will be assessed at Month 12.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Proportion of patients in remission over the course of the study
    Description
    The time in remission over the course of the study; occurrence of surgery or hospitalization for Ulcerative Colitis; occurrence of disease-related complications; health related QoL (Short-Form 36 questionnaire [SF-36] and EuroQoL instrument [EQ-5D]); and, subject
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records -- - Documented diagnosis of UC with a Mayo Clinic Score (MCS) ≥6 and a baseline Mayo Endoscopy Score >2. Either an elevated serum C-reactive protein (CRP) (above the Upper Level of Normal (ULN) according to local laboratory results) or elevated fecal calprotectin (> 250 mg/kg) concentration. Requires sigmoidoscopic evaluation at baseline (standard of care) Written informed consent must be obtained and documented. Ability of subject to participate fully in all aspects of this clinical trial in the opinion of the investigator. Exclusion Criteria: Previous failure of TNF antagonist therapy Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer. Pregnant or lactating women. Any conditions (e.g., history of alcohol or substance abuse) which in the opinion of the investigator, may interfere with the subject's ability to comply with study procedures.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian G Feagan, MD
    Organizational Affiliation
    Alimentiv Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20068560
    Citation
    Kornbluth A, Sachar DB; Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010 Mar;105(3):501-23; quiz 524. doi: 10.1038/ajg.2009.727. Epub 2010 Jan 12. Erratum In: Am J Gastroenterol. 2010 Mar;105(3):500.
    Results Reference
    background
    PubMed Identifier
    18295023
    Citation
    D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkuhn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.
    Results Reference
    background
    PubMed Identifier
    20393175
    Citation
    Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.
    Results Reference
    background
    PubMed Identifier
    3317057
    Citation
    Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.
    Results Reference
    background
    PubMed Identifier
    17258735
    Citation
    D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.
    Results Reference
    background

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