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

• Register: EUCTR
• Last refreshed on: 31 August 2020
• Main ID: EUCTR2014-001050-41-DE
• Date of registration: 15/12/2014
• Prospective Registration: Yes
• Primary sponsor: Robarts Clinical Trials
• Public title: Randomized Evaluation of an Algorithm for Crohn's Treatment - Study 2
• Scientific title: A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease - REACT2
• Date of first enrolment: 12/06/2015
• Target sample size: 1200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001050-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Cluster Randomization; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Cluster randomization into 2 different treatment strategies/algorithms; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Canada, Germany, United Kingdom, United States

Contacts

• Name: Project Director
• Affiliation: Robarts Clinical Trials Inc.

• Name: Project Director
• Affiliation: Robarts Clinical Trials Inc.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn's Disease
MedDRA version: 20.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection

Primary Outcome(s)

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.

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

Secondary Objective: N/A

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 6 months, 12 months and 24 months

Secondary end point(s): - Risk of CD-related complications at 6 months and 12 months.
- Time to first CD-related complication.
- Risk of CD-related hospitalizations at 6 months and 12 months.
- Time to first CD-related hospitalization.
- Risk of all cause hospitalization at 6 months and 12 months.
- Time to first all cause hospitalization.
- Proportion of patients at one and two years who are in Deep Remission, defined as HBI = 4, no steroids for the treatment of CD, and normal C-reactive protein
- Proportion of patients at one and two years who are in Deep Remission without disease progression where 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)
- Proportion of patients at one and two years who are in clinical remission (HBI = 4)
- Change in C-reactive protein
- Change in health related QoL (EuroQoL instrument [EQ-5D]), patient and physician global rating
- Patient and physician satisfaction

Secondary ID(s)

RP1202

NCT01698307

Source(s) of Monetary Support

AbbVie Inc.

Robarts Clinical Trials

Ethics review

Status: Approved
Approval date: 12/06/2015
Contact: