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

Alimentiv

Status and phase: Completed; Phase 4

Conditions: Crohn's Disease

Treatments: Other: Conventional Step-care Algorithm; Other: Enhanced Treatment Algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT01698307

RP1202

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,095 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 24 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,095 participants in 2 patient groups

Enhanced Treatment Algorithm

Active Comparator group

Description:

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.

Treatment:

Other: Enhanced Treatment Algorithm

Conventional Step-care Algorithm

Other group

Description:

Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Index (HBI).

Treatment:

Other: Conventional Step-care Algorithm