Care Path for the Management of Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Enhanced treatment algorithm

Intervention Type OTHER

Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.

Usual Care

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

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type OTHER

usual step care practice

Interventions

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Enhanced treatment algorithm

Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.

Intervention Type OTHER

Usual Care

usual step care practice

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No