Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:March 2014
End Date:February 2021

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A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease

Assess if the implementation of an enhanced treatment algorithm will improve the management
Crohn's Disease compared to a conventional Step-care approach.

Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During
disease exacerbations, pharmacological or surgical intervention is usually needed to
re-establish remission. Ideally, strategies should be employed to maintain patients in
long-term remission while minimizing exposure to corticosteroids and reduce therapy-related
toxicity.

Nevertheless, in reality many patients with CD do not receive effective therapy and their
disease often remains active, leading to uncontrolled inflammation and complications from
either the underlying disease or corticosteroids.

Inclusion Criteria:

- Documented diagnosis of CD

- Written informed consent must be obtained and documented.

- Willing to utilize study supply of adalimumab provided in syringe format, if indicated
according to treatment algorithm.

Exclusion Criteria:

- Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of
the investigator, may interfere with the patient's ability to comply with study
procedures.

- Latex allergy or other conditions in which adalimumab syringes are contraindicated

- Currently participating, or planning to participate in a study involving
investigational product within 12 months that may interfere with the patient's ability
to comply with study procedures.

- Previously failed all classes of tumor necrosis factor (TNF) antagonists for the
treatment of CD.

- Diagnosis of short bowel syndrome
We found this trial at
3
sites
Asheville, North Carolina 28801
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Shreveport, Louisiana 71101
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Sudbury, Ontario
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Sudbury,
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