Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy (REACT2)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01698307
First received: September 28, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Crohn's Disease
Other: Enhanced Treatment Algorithm
Other: Conventional Step-care Algorithm
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 an Enhanced Treatment Algorithm for the Management of Crohn's Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Risk of CD-related complications at one-year, measured at the practice level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CD-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.


Secondary Outcome Measures:
  • Risk of CD-related complications at 6 months. [ Time Frame: six months ] [ Designated as safety issue: No ]
    CD-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures.


Other Outcome Measures:
  • Proportion of patients at one year who are in Deep Remission without disease progression [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    Disease progression is defined as the de novo development of strictures or fistula, the occurrence of an intra-abdominal abscess, or surgery for CD (resection, bypass, stricturoplasty).


Estimated Enrollment: 1200
Study Start Date: March 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Other: Enhanced Treatment Algorithm
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
Other Name: Adalimumab
Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).
Other: Conventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698307

Locations
United States, Louisiana
Louisana Research Center LLC
Shreveport, Louisiana, United States, 71101
United States, North Carolina
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States, 28801
Canada, Ontario
Sudbury Endoscopy Center
Sudbury, Ontario, Canada, P3C 5K6
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Brian G Feagan, MD Robarts Clinical Trials - Western University
  More Information

Publications:

Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01698307     History of Changes
Other Study ID Numbers: RP1202
Study First Received: September 28, 2012
Last Updated: April 7, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Germany: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Western Ontario, Canada:
Crohn's Disease
Deep Remission
Complications

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antimetabolites
Adalimumab
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 20, 2014