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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 (CREDO2)

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ClinicalTrials.gov Identifier: NCT03487900
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
AbbVie
Takeda
Celgene
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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.


Condition or disease Intervention/treatment Phase
CD Diagnostic Test: Colonoscopy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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: a Multicenter Prospective Cohort Study
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Clinical remission CD Diagnostic Test: Colonoscopy
Colonoscopy for CD patients in clinical remission




Primary Outcome Measures :
  1. Sustained clinical remission at week 104 [ Time Frame: Week 104 ]

Secondary Outcome Measures :
  1. Sustained clinical remission at week 52 [ Time Frame: Week 52 ]
  2. Sustained clinical remission at week 26 [ Time Frame: Week 26 ]
  3. Time to disease flare based on biomarker measurement [ Time Frame: Week 104 ]
  4. Sustained clinical remission according to treatment group as an exploratory endpoint [ Time Frame: Week 104 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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/or 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487900


Contacts
Contact: Yoram Bouhnik, MD. PhD 00 33 6 20 47 22 52 yoram.bouhnik@gmail.com

Locations
Belgium
Leuven University Hospital Not yet recruiting
Leuven, Belgium, 3000
Contact: Peter Bossuyt, MD    +32 4 98 72 56 47    peter.bossuyt@Imelda.be   
Principal Investigator: Peter Bossuyt, MD         
France
APHP- Hopital BEAUJON Recruiting
Clichy, France, 92110
Contact: YORAM BOUHNIK, MD       yoram.bouhnik@gmail.com   
Principal Investigator: YORAM BOUHNIK, MD         
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
AbbVie
Takeda
Celgene

Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT03487900     History of Changes
Other Study ID Numbers: GETAID 2017-002
2017-003345-15 ( EudraCT Number )
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: ND

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No