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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

UnknownNA

Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Conditions: CD

Interventions: Colonoscopy

Countries: Belgium, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. ≥18 year of age
2. Established CD for more than 6 months with histopathological confirmation available in the medical records of the patient
3. Clinical remission as considered by the investigators global assessment ≥3 consecutive months
4. Clinical remission at baseline (CDAI \<150) and CRP \<5 mg/l and fecal calprotectin \<250 μg/g
5. CD maintenance treatment needs to be stable for ≥3 months before baseline
6. Planned ileocolonoscopy for CD
7. Permitted maintenance treatment for CD: immunomodulators (Azathioprine, 6-mercaptopurine, methotrexate), biologicals (infliximab, adalimumab, certolizumab, golimumab, ustekinumab, vedolizumab) and JAK inhibitors
8. No planned escalation of treatment after baseline endoscopy
9. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures

Exclusion Criteria:

1. Pregnancy at time of endoscopy
2. People unable to give their consent (because of their physical or mental state).
3. Absence of written consent.
4. Ulcerative colitis or IBD type unclassified
5. Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy
6. Incomplete recording of the endoscopy or more than three resected ileocolonic segments (not counting ileocecal valve)
7. Non-steroidal anti-inflammatory drugs intake within two weeks before baseline endoscopy
8. Perianal fistulizing CD without luminal disease
9. Contraindication for endoscopy
10. Inaccessible ileocolonic segment even after attempt of endoscopic balloon dilation
11. Suspicion of gastrointestinal infection within 4 weeks prior to baseline endoscopy
12. Documented active or suspicion of intestinal tuberculosis
13. Conditions which in the opinion of the investigator may interfere with the subject's ability to comply to the follow up with the study procedures.

CREDO2-GT2017002 Getaid\_CREDO2-Protocol\_v1.1\_20171130 Page 18 of 37
14. Exclusive CD of the upper gastrointestinal tract (Montreal classification L4)
15. Montreal classification L1 without terminal ileal involvement
16. Colon preparation with solutions other than PEG or picosulphate solutions
17. Incomplete recording of the baseline endoscopy.

Locations (14)

Ghent, Belgium
Leuven, Belgium
Leuven, Belgium
Liège, Belgium
Besançon, France
Clermont-Ferrand, France
Clichy, France
Lille, France
Montpellier, France
Nancy, France
Nantes, France
Nice, France
Paris, France
Pessac, France