Status:
TERMINATED
Care Path for the Management of Ulcerative Colitis
Lead Sponsor:
University of Western Ontario, Canada
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT01882426
Start Date
May 1 2014
End Date
May 1 2016
Last Update
May 13 2016
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