Care Path for the Management of Ulcerative Colitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01882426
First received: June 17, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Ulcerative Colitis
Other: Enhanced treatment algorithm
Other: Usual Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Cluster Randomized Controlled Trial of a Care-Path for the Management of Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Proportion of patients in remission at the end of 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 2400
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 17, 2013
Last Updated: May 21, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by University of Western Ontario, Canada:
Cluster randomization controlled trial
Remission
Gastroenterology practices in Canada and the United States
Sigmoidoscopy

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

ClinicalTrials.gov processed this record on October 20, 2014