Is the Endoscopic Remission Evaluation, Using the CREDO 1 Index / Score in CD Patients in Clinical Remission at Baseline, Predictive of Sustained Clinical Remission Using a 2-year Follow up
NCT03487900 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2022-08-03
Summary
The CREDO 2 study follows CREDO 1 study, which aims to construct an objective evaluation of endoscopic remission in Crohn's Disease (CD). In addition to reproducibility and validation, the predictive value of this remission evaluation needs to be tested in different settings to valorise its usefulness in clinical practice and in clinical trials.
CREDO 2 aims to investigate whether the evaluation of endoscopic remission, as defined in CREDO 1, in patients in clinical remission is predictive of sustained clinical remission at 2 years.
The design of CREDO2 is a multicentre longitudinal prospective cohort study. The screening period to include a patient is two weeks. Patients will be followed up to week 104.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
Colonoscopy
Colonoscopy for CD patients in clinical remission
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
Celgene
collaborator INDUSTRY - collaborator INDUSTRY
-
Roche Pharma AG
collaborator INDUSTRY - collaborator INDUSTRY
-
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-13
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Belgium
- France
Study Locations
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