CDCREDO1NCT03498625
Crohn's Disease Endoscopic REmission Definition in an Objective Way
A study testing Colonoscopy in people with CD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in 2 countries.
Trial summary
The CDEIS (Crohn's disease endoscopic index of severity) and its derivative, SES-CD (single endoscopic score for Crohn's disease) were constructed to evaluate the endoscopic severity of Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD
- What is being tested?
- Colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Mar 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years 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 defined as CDAI <150 at the moment of the endoscopy and CRP <5 mg/l and fecal calprotectin <250 µg/g
- Planned ileocolonoscopy for CD
- All treatments for CD are allowed
- The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Who cannot join
- 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
- Less than 3 evaluable ileocolonic segments (Incomplete recording of the endoscopy or more than three resected ileocolonic segments (not counting ileocecal valve)) in CREDO 2
Show all 16Show fewer
- 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.
- Exclusive CD of the upper gastrointestinal tract (Montreal classification L4)
- Montreal classification L1 without terminal ileal involvement
- Colon preparation with solutions other than macrogol or picosulphate solutions
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The CDEIS (Crohn's disease endoscopic index of severity) and its derivative, SES-CD (single endoscopic score for Crohn's disease) were constructed to evaluate the endoscopic severity of Crohn's disease (CD). The current therapeutic goal in CD is endoscopic remission, which is thought to be predictive of a favourable evolution of the disease. However, up to now there is no measure of endoscopic remission, objectively constructed and validated, not even a consensus for its definition. An objective measure of endoscopic remission is necessary, notably for the evaluation of new treatments, a request of the regulatory agencies (FDA and EMA), but also in clinical practice if one wishes to adapt the treatment of patient according to the level of endoscopic remission.
The aim of the study is to construct a measure of endoscopic remission based on an objective assessment (depth or grade) of remission, that must be reproducible, little or not dependent on the reader interpreting the endoscopy.
Read more
The CREDO 1 program is a cross-sectional study designed to construct objectively a measure of the endoscopic remission of CD through an index measuring its depth or a score measuring its grade and to evaluate its reproducibility.
This study is composed of four main parts:
- Training and selection of readers:
- Selection and definition of all lesions to be studied at consensus meetings, first between the central readers, then with the participation of local investigators.
- Specific training of local investigators in the recognition of endoscopic lesions
- Checking the performance of the central readers
- Recruitment of patients by investigators - local readers:
- Inclusion criteria: CD diagnosed for more than 6 months, in clinical remission for at least 3 months, with a Crohn's disease activity index < 150 at the time of endoscopy.
- Each local investigator will have to record 15 videos divided according to his/her overall judgment into 3 status of remission: Complete Remission; Remission almost complete; Remission neither complete nor nearly complete.
- The colon will be divided into 7 segments: ileum, ileocecal valve, right colon, transverse colon, descending colon, sigmoid colon and rectum. Each segment will be identified by landmarks.
- Videos will be anonymized and then centralized at a healthcare provider (OVH - SAS).
- 16 French and Belgian centers will participate in the study leading to a total of 240 films.
- Analysis of videos by central readers:
- 12 central readers will independently read 80 out of the 240 videos
- Videos allocation to central readers will be performed through balanced incomplete block method to ensure that each central reader, as well as each central reader pair, has the same weight in achieving the results.
- A quantitative evaluation of the depth of endoscopic remission on a visual analogue scale and a qualitative evaluation of the grade of remission on a 5-level ordinal scale will be provided by each central reader, segment by segment and globally, in addition to the description of all lesions identified by segment.
- Analysis of the data recorded by the central readers:
- An index (depth of remission) or score (grade of remission) will be constructed from linear or multiple logistic regression models, considering the reader and endoscopy as random factors, to take into account the dependence between the readings performed on different endoscopies by the same central reader or on the same endoscopy by different readers.
- Variations in readings between central readers will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.
In an observational longitudinal multi-center cohort study (CREDO 2), it will be tested whether the index or score thus constructed is able to predict prolonged clinical remission for 2 years in patients in clinical remission at baseline. If this test is successful, we will have a primary objective and reproducible criterion for evaluating treatments in CD and a useful tool for the management of these patients in clinical practice.
- Conditions
- CD
- Being tested
- Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic test
Colonoscopy for CD patients in clinical remission
| Study group | Role | What they receive |
|---|---|---|
| Clinical remission CD | Other | Not described Receives: Diagnostic Test: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Building an objective definition of the depth or grade of endoscopic remission in relation to what is observed during endoscopy in CD patients presenting with clinical remission
12 Central Readers, selected from the participating centers independent of the patient selection will be involved in the central reading process. They will have experience in IBD endoscopy and its evaluation and will be involved in the lesions' selection that need to be described during videos' readings. Videos allocation will be done by a randomized balanced incomplete block design. Each CR will review 80 videos and each video will be read by 4 CR (6 couples of 2 CR). The efficacy of this design is 0.90, meaning that this design has the same power than a complete design with a sample size reduced by 10% whereas the reading burden is reduced by 67% (80 instead of 240). Six videos, two of each remission status randomly selected, will be read a second time by the CRs to assess intra observer variability. The CR will provide the detection and quantification of the lesions in the endoscopic images, and a quantitative and qualitative remission evaluation
Measured: 1 Year
Secondary outcomes (2)
Intra- and inter-observer variability of what is observed during endoscopy in CD
For each observed segment, the central reader will first evaluate the quality of the bowel preparation and the recording, secondly the CR documents all lesions, detected or not, and quantified those detected, then the CR will perform his/her segmental endoscopic remission evaluation, qualitative on a 5-grade scale and quantitative on a linear analogue scale. Finally, after the readings of all segments, the CR will provide his/her global endoscopic remission evaluations, qualitative on a 5-grade scale and quantitative on a linear analogue scale. Each CR will review 80 videos and each video will be read by 4 CR (6 couples of 2 CR). Based on the this the inter-observer variability will be assessed. Six videos, two of each remission status randomly selected, will be read a second time in a random order by each of the 12 CRs to assess intra observer variability.
Measured: 1 Year
Intra- and inter-observer variability of depth and grade of endoscopic remission in CD
For the quantitative evaluation, the CR had to:
- provide his/her evaluation of depth of remission per segment (ileum, ileocecal valve, ascending colon, transverse colon, descending colon, sigmoid colon and rectum) in marking a cross on a linear analog scale, with left extremity being absolutely no remission and right extremity being absolutely complete remission. The evaluation needs to be done directly after the viewing of the segment not at the end of the viewing of the complete recording.
- provide his/her evaluation of the depth of remission globally in marking a cross on a linear analog scale, with left extremity being absolutely no remission and right extremity being absolutely complete remission. The global evaluation needs to be done after the viewing of the complete recording. This global evaluation is not necessarily equal to the maximum or to the mean of the segmental evaluations.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start13 Mar 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, Biogen, Celgene, Gilead Sciences, Roche Pharma AG, Takeda
- Responsible party
- Sponsor
- Investigators
- Yoram Bouhnik, MD PhD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesPeter Bossuyt, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498625
- Sponsor's protocol ID
- GETAID 2017-001
- Other IDs
- 2017-003345-15, 2017
- Acronym
- CREDO1
- Status last verified
- Aug 2022
- First submitted
- 28 Mar 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: ND
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crohn's Disease Endoscopic REmission Definition in an Objective Way
- ClinicalTrials.gov ID
- NCT03498625
- Acronym / sponsor ID
- CREDO1 / GETAID 2017-001
- Conditions
- CD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Collaborators
- AbbVie, Biogen, Celgene, Gilead Sciences, Roche Pharma AG, Takeda
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CDEIS (Crohn's disease endoscopic index of severity) and its derivative, SES-CD (single endoscopic score for Crohn's disease) were constructed to evaluate the endoscopic severity of Crohn's disease (CD). The current therapeutic goal in CD is endoscopic remission, which is thought to be predictive of a favourable evolution of the disease. However, up to now there is no measure of endoscopic remission, objectively constructed and validated, not even a consensus for its definition. An objective measure of endoscopic remission is necessary, notably for the evaluation of new treatments, a request of the regulatory agencies (FDA and EMA), but also in clinical practice if one wishes to adapt the treatment of patient according to the level of endoscopic remission.
The aim of the study is to construct a measure of endoscopic remission based on an objective assessment (depth or grade) of remission, that must be reproducible, little or not dependent on the reader interpreting the endoscopy.
The CREDO 1 program is a cross-sectional study designed to construct objectively a measure of the endoscopic remission of CD through an index measuring its depth or a score measuring its grade and to evaluate its reproducibility.
This study is composed of four main parts:
- Training and selection of readers:
- Selection and definition of all lesions to be studied at consensus meetings, first between the central readers, then with the participation of local investigators.
- Specific training of local investigators in the recognition of endoscopic lesions
- Checking the performance of the central readers
- Recruitment of patients by investigators - local readers:
- Inclusion criteria: CD diagnosed for more than 6 months, in clinical remission for at least 3 months, with a Crohn's disease activity index < 150 at the time of endoscopy.
- Each local investigator will have to record 15 videos divided according to his/her overall judgment into 3 status of remission: Complete Remission; Remission almost complete; Remission neither complete nor nearly complete.
- The colon will be divided into 7 segments: ileum, ileocecal valve, right colon, transverse colon, descending colon, sigmoid colon and rectum. Each segment will be identified by landmarks.
- Videos will be anonymized and then centralized at a healthcare provider (OVH - SAS).
- 16 French and Belgian centers will participate in the study leading to a total of 240 films.
- Analysis of videos by central readers:
- 12 central readers will independently read 80 out of the 240 videos
- Videos allocation to central readers will be performed through balanced incomplete block method to ensure that each central reader, as well as each central reader pair, has the same weight in achieving the results.
- A quantitative evaluation of the depth of endoscopic remission on a visual analogue scale and a qualitative evaluation of the grade of remission on a 5-level ordinal scale will be provided by each central reader, segment by segment and globally, in addition to the description of all lesions identified by segment.
- Analysis of the data recorded by the central readers:
- An index (depth of remission) or score (grade of remission) will be constructed from linear or multiple logistic regression models, considering the reader and endoscopy as random factors, to take into account the dependence between the readings performed on different endoscopies by the same central reader or on the same endoscopy by different readers.
- Variations in readings between central readers will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.
In an observational longitudinal multi-center cohort study (CREDO 2), it will be tested whether the index or score thus constructed is able to predict prolonged clinical remission for 2 years in patients in clinical remission at baseline. If this test is successful, we will have a primary objective and reproducible criterion for evaluating treatments in CD and a useful tool for the management of these patients in clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical remission CD | Other | Diagnostic Test: Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years 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 defined as CDAI <150 at the moment of the endoscopy and CRP <5 mg/l and fecal calprotectin <250 µg/g
- Planned ileocolonoscopy for CD
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyColonoscopy for CD patients in clinical remission | Diagnostic test | Clinical remission CD |
Primary outcome
Building an objective definition of the depth or grade of endoscopic remission in relation to what is observed during endoscopy in CD patients presenting with clinical remission
Time frame: 1 Year
12 Central Readers, selected from the participating centers independent of the patient selection will be involved in the central reading process. They will have experience in IBD endoscopy and its evaluation and will be involved in the lesions' selection that need to be described during videos' readings. Videos allocation will be done by a randomized balanced incomplete block design. Each CR will review 80 videos and each video will be read by 4 CR (6 couples of 2 CR). The efficacy of this design is 0.90, meaning that this design has the same power than a complete design with a sample size reduced by 10% whereas the reading burden is reduced by 67% (80 instead of 240). Six videos, two of each remission status randomly selected, will be read a second time by the CRs to assess intra observer variability. The CR will provide the detection and quantification of the lesions in the endoscopic images, and a quantitative and qualitative remission evaluation
2 secondary outcomes
Intra- and inter-observer variability of what is observed during endoscopy in CD
Time frame: 1 Year
Intra- and inter-observer variability of depth and grade of endoscopic remission in CD
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided. ND
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Bouhnik, MD PhD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Peter Bossuyt, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with CD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Building an objective definition of the depth or grade of endoscopic remission in relation to what is observed during endoscopy in CD patients presenting with clinical remission (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.