CDMICANCT02856763
Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess
An observational study of CD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in France.
Trial summary
To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CD
- How many people
- 125 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2013to Apr 2020
- Phase
- Observational
- 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
Study population: Patients presenting a luminal Crohn's disease complicated by an intra abdominal and/or pelvic abscess meeting the inclusion criteria and followed or addressed in one of the participating centers will be enrolled in the pre-inclusion phase of the study consisting in abscess drainage and antibiotic therapy as recommended by local and European guidelines. - After the initial pre-inclusion phase of the study, if there is a complete resolution of sepsis and abscess confirmed by MRE, patients for whom the treating physician decides to introduce adalimumab according to local and European Guidelines will be included in the anti-TNF treatment phase.
Who may be able to join
- Age greater than 18 years.
- Diagnosis of Crohn's disease (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
- AND diagnosis of spontaneous intra-abdominal and/or pelvic abscess according to radiologic criteria confirmed by US, CT or magnetic resonance enterography (MRE).
- In patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies
- Written consent MAIN
Who cannot join
- Age under 18 years. - Absence of written consent. - Post-operative abscess (occurring within 12 weeks after intestinal resection). - Isolated intra-parietal abscess of small intestine or colon. - Need for immediate surgery including irreversible bowel obstruction, peritonitis or uncontrolled sepsis. - Perineal abscess complicating perianal Crohn's disease. - Abscess developing under anti-TNF therapy. - Previous failure or intolerance to adalimumab. - Contraindication to anti-TNF therapy.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study
To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.
Read the detailed description
Multicenter prospective observational cohort.
Initial management of sepsis and abscess (Before anti-TNF therapy initiation) i. Antibiotics. ii. Percutaneous drainage will be performed every time when possible iii. Surgical drainage will be performed if percutaneous drainage is not accessible or fails iv.
Concomitant medications :
- Steroids will be rapidly tapered and stopped.
- Azathioprine, 6-mercaptopurtine, 5-ASA derivatives and methotrexate will be maintained at a stable dose.
- If not present at inclusion, immunosuppressors could be introduced at the discretion of investigator
- Antibiotics could be used if needed for infections not related to intra-abdominal abscess recurrence and Crohn's disease. v.
Supportive care including artificial nutrition will be started if necessary.
- Anti-TNF therapy:
- The anti-TNF agent will be adalimumab, administered as subcutaneous injection of 160 mg at W0, 80 mg at W2, followed by 40 mg every 2 weeks.
- Conditions
- CD
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive factors of adalimumab (anti TNF) failure at Week 24.
W24 adalimumab failure in this context is defined as: o Need for intestinal resection, o or Need to begin steroids after 12 weeks of adalimumab treatment, o or Abscess recurrence confirmed by MRE, o or Clinical relapse defined as CDAI > 220 or HBI > 4 (table 3) and CRP > 10 mg/L at two consecutive visits
Measured: Week 24
Secondary outcomes (6)
Clinical Remission
- Clinical remission (CDAI <150 or HBI ≤ 4) at each visit until W48
Measured: Week 48
Monitoring of obstructive symptoms
- Monitoring of obstructive symptoms to determine the degree of CD related bowel obstruction (Obstructive abdominal pain, nausea, vomiting, dietary restriction due to symptoms, bowel obstruction, cf. table 3) at each visit until W48.
Measured: Week 48
Evolution of items measured by MRE
Evolution of items measured by MRE between inclusion and week 24
Measured: Week 24
hospital stay
- Length of hospital stay.
Measured: Week 48
SAE
- Serious adverse events or severe infections leading to definitive treatment withdrawal.
Measured: Week 48
Death
Death related to CD between D0 and W24.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startApr 2013
- Primary completionJan 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoram Bouhnik, MD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesGuillaume Pineton de Chambrun, MD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856763
- Sponsor's protocol ID
- GETAID 2012-1
- Other IDs
- 2012-000982-19
- Acronym
- MICA
- Status last verified
- Jan 2021
- First submitted
- 21 Jun 2015
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Bouhnik Y, Pineton de Chambrun G, Lambert J, Nachury M, Seksik P, Altwegg R, Vuitton L, Stefanescu C, Nancey S, Aubourg A, Serrero M, Filippi J, Desseaux K, Viennot S, Abitbol V, Boualit M, Bourreille A, Giletta C, Buisson A, Roblin X, Dib N, Malamut G, Amiot A, Fumery M, Louis E, Elgharabawy Y, Peyrin-Biroulet L; MICA-GETAID Study Group. Adalimumab in Biologic-naive Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3365-3378.e5. doi: 10.1016/j.cgh.2023.01.013. Epub 2023 Jan 31.
PubMed 36731588
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02856763
- Acronym / sponsor ID
- MICA / GETAID 2012-1
- Conditions
- CD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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.
To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.
Detailed description
Multicenter prospective observational cohort.
Initial management of sepsis and abscess (Before anti-TNF therapy initiation) i. Antibiotics. ii. Percutaneous drainage will be performed every time when possible iii. Surgical drainage will be performed if percutaneous drainage is not accessible or fails iv.
Concomitant medications :
- Steroids will be rapidly tapered and stopped.
- Azathioprine, 6-mercaptopurtine, 5-ASA derivatives and methotrexate will be maintained at a stable dose.
- If not present at inclusion, immunosuppressors could be introduced at the discretion of investigator
- Antibiotics could be used if needed for infections not related to intra-abdominal abscess recurrence and Crohn's disease. v.
Supportive care including artificial nutrition will be started if necessary.
- Anti-TNF therapy:
- The anti-TNF agent will be adalimumab, administered as subcutaneous injection of 160 mg at W0, 80 mg at W2, followed by 40 mg every 2 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting a luminal Crohn's disease complicated by an intra abdominal and/or pelvic abscess meeting the inclusion criteria and followed or addressed in one of the participating centers will be enrolled in the pre-inclusion phase of the study consisting in abscess drainage and antibiotic therapy as recommended by local and European guidelines. - After the initial pre-inclusion phase of the study, if there is a complete resolution of sepsis and abscess confirmed by MRE, patients for whom the treating physician decides to introduce adalimumab according to local and European Guidelines will be included in the anti-TNF treatment phase.
Key inclusion criteria (5 listed)
- Age greater than 18 years.
- Diagnosis of Crohn's disease (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
- AND diagnosis of spontaneous intra-abdominal and/or pelvic abscess according to radiologic criteria confirmed by US, CT or magnetic resonance enterography (MRE).
- In patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant or who are intolerant to or have medical contraindications for such therapies
- Written consent MAIN
Key exclusion criteria (1 listed)
- Age under 18 years. - Absence of written consent. - Post-operative abscess (occurring within 12 weeks after intestinal resection). - Isolated intra-parietal abscess of small intestine or colon. - Need for immediate surgery including irreversible bowel obstruction, peritonitis or uncontrolled sepsis. - Perineal abscess complicating perianal Crohn's disease. - Abscess developing under anti-TNF therapy. - Previous failure or intolerance to adalimumab. - Contraindication to anti-TNF therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of predictive factors of adalimumab (anti TNF) failure at Week 24.
Time frame: Week 24
W24 adalimumab failure in this context is defined as: o Need for intestinal resection, o or Need to begin steroids after 12 weeks of adalimumab treatment, o or Abscess recurrence confirmed by MRE, o or Clinical relapse defined as CDAI > 220 or HBI > 4 (table 3) and CRP > 10 mg/L at two consecutive visits
6 secondary outcomes
Clinical Remission
Time frame: Week 48
Monitoring of obstructive symptoms
Time frame: Week 48
Evolution of items measured by MRE
Time frame: Week 24
hospital stay
Time frame: Week 48
SAE
Time frame: Week 48
Death
Time frame: Week 24
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 20 Jan 2021.
- Derived from this study: PubMed 36731588Bouhnik Y, Pineton de Chambrun G, Lambert J, Nachury M, Seksik P, Altwegg R, Vuitton L, Stefanescu C, Nancey S, Aubourg A, Serrero M, Filippi J, Desseaux K, Viennot S, Abitbol V, Boualit M, Bourreille A, Giletta C, Buisson A, Roblin X, Dib N, Malamut G, Amiot A, Fumery M, Louis E, Elgharabawy Y, Peyrin-Biroulet L; MICA-GETAID Study Group. Adalimumab in Biologic-naive Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3365-3378.e5. doi: 10.1016/j.cgh.2023.01.013. Epub 2023 Jan 31.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Guillaume Pineton de Chambrun, MD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CD, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in France.
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 5 inclusion and 1 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 20 Jan 2021. 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 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?
Identification of predictive factors of adalimumab (anti TNF) failure at Week 24. (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02856763, which also lists 1 linked publication.
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 20 Jan 2021.