Randomized Evaluation of an Algorithm for Crohn's Treatment - Study 2

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 20.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-001050-41-DE
• Lead Sponsor: Robarts Clinical Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-15
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

(1) Male or female patients 18 years or older.
(2) Documented diagnosis of CD.
(3) Written informed consent must be obtained and documented.
(4) Willing to utilize study supply of adalimumab, if indicated according to treatment algorithm.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

(1) Any conditions (e.g., history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
(2) Latex allergy or other conditions in which adalimumab syringes are contraindicated, or any conditions in which adalimumab/TNF antagonist treatment is contraindicated.
(3) 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.
(4) Previously failed all classes of TNF antagonists for the treatment of CD.
(5) Diagnosis of short bowel syndrome.
(6) Current diagnosis of tuberculosis (TB) (active or latent), active or chronic hepatitis B.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to compare the efficacy of an Enhanced algorithm that incorporates 1) early combination therapy and 2) objective evaluation of disease activity to guide treatment targeting Deep Remission as the goal of therapy, to a conventional Step-care approach to the management of CD. ;Secondary Objective: N/A;Primary end point(s): Primary Efficacy Measure: risk of CD-related complications at one-year, measured at the practice level. CD-related complications include (1) CD-related surgeries, non-surgical CD events such as disease flare, bowel obstruction, 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 ;Timepoint(s) of evaluation of this end point: Risk of CD-related complications at two years