Status:
UNKNOWN
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
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborating Sponsors:
AbbVie
Biogen
Conditions:
CD
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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)
- Montreal classification L1 without terminal ileal involvement
- Colon preparation with solutions other than PEG or picosulphate solutions
- Incomplete recording of the baseline endoscopy.
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03487900
Start Date
March 13 2018
End Date
December 31 2023
Last Update
August 3 2022
Active Locations (14)
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1
AZ Sint Lucas Gent
Ghent, Belgium
2
Leuven University Hospital
Leuven, Belgium, 3000
3
UZ Leuven
Leuven, Belgium
4
CHU Liège
Liège, Belgium