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 | Unknown

• 2 other identifiers: GETAID 2017-0022017-003345-15
• Study Type: interventional
• Target: 320
• Locations: 2 countries
• Sites: 14

Brief 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

CD

Outcome Measures

Primary Outcomes (1)

• Sustained clinical remission at week 104

  Week 104

Secondary Outcomes (4)

• Sustained clinical remission at week 52

  Week 52

• Sustained clinical remission at week 26

  Week 26

• Time to disease flare based on biomarker measurement

  Week 104

• Sustained clinical remission according to treatment group as an exploratory endpoint

  Week 104

Study Arms (1)

Clinical remission CD

OTHER

Diagnostic Test: Colonoscopy

Interventions

Colonoscopy DIAGNOSTIC_TEST

Colonoscopy for CD patients in clinical remission

Clinical remission CD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy at time of endoscopy
• People unable to give their consent (because of their physical or mental state).
• Absence of written consent.
• Ulcerative colitis or IBD type unclassified
• Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy
• Incomplete recording of the endoscopy or more than three resected ileocolonic segments (not counting ileocecal valve)
• Non-steroidal anti-inflammatory drugs intake within two weeks before baseline endoscopy
• Perianal fistulizing CD without luminal disease
• Contraindication for endoscopy
• Inaccessible ileocolonic segment even after attempt of endoscopic balloon dilation
• Suspicion of gastrointestinal infection within 4 weeks prior to baseline endoscopy
• Documented active or suspicion of intestinal tuberculosis
• 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
• Exclusive CD of the upper gastrointestinal tract (Montreal classification L4)

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead
• AbbVie: collaborator
• Biogen: collaborator
• Celgene: collaborator
• Gilead Sciences: collaborator
• Roche Pharma AG: collaborator
• Takeda: collaborator

Study Sites (14)

AZ Sint Lucas Gent

Ghent, Belgium

Location

Leuven University Hospital

Leuven, 3000, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

CHU Liège

Liège, Belgium

Location

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

Location

CHU Estaing - Clermont Ferrand

Clermont-Ferrand, France

Location

APHP- Hopital BEAUJON

Clichy, 92110, France

Location

CHRU de Lille - Hôpital C. Huriez

Lille, France

Location

CHU Montpellier - Hôpital Saint Eloi

Montpellier, France

Location

CHU Nancy - Hôpital Barbois

Nancy, France

Location

CHU Nantes - Hôtel Dieu

Nantes, France

Location

CHU de Nice - Hôpital de l'Archet 2

Nice, France

Location

Hôpital Saint Antoine

Paris, France

Location

CHU Bordeaux - Hôpital Haut Lévêque

Pessac, France

Location

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 4, 2018
• Study Start: March 13, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

FR (10); BE (4)