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Care Path for the Management of Ulcerative Colitis (CONSTRUCT)

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ClinicalTrials.gov Identifier: NCT01882426
Recruitment Status : Terminated
First Posted : June 20, 2013
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Enhanced treatment algorithm Other: Usual Care Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cluster Randomized Controlled Trial of a Care-Path for the Management of Ulcerative Colitis
Study Start Date : May 2014
Primary Completion Date : November 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Enhanced treatment algorithm
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
Other: Enhanced treatment algorithm
Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.
Placebo Comparator: Usual Care
These subjects will be managed according to local treatment guidelines for the treatment of UC.
Other: Usual Care
usual step care practice


Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients in remission at the end of 12 months. [ Time Frame: 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 :
  1. Proportion of patients in remission over the course of the study [ Time Frame: 18 months ]
    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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

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): NCT01882426


Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Brian G Feagan, MD Robarts Clinical Trials Inc.
More Information

Publications:

Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01882426     History of Changes
Other Study ID Numbers: RP1206
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by University of Western Ontario, Canada:
CONSTRUCT
Cluster randomization controlled trial
Gastroenterology practices in North America

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases