Clinical trial NCT02856763: Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess
Official title: Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CD
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Identification of predictive factors of adalimumab (anti TNF) failure at Week 24.
timeFrame: Week 24
Secondary outcomes:
measure: Clinical Remission
timeFrame: Week 48
measure: Monitoring of obstructive symptoms
timeFrame: Week 48
measure: Evolution of items measured by MRE
timeFrame: Week 24
measure: hospital stay
timeFrame: Week 48
measure: SAE
timeFrame: Week 48
measure: Death
timeFrame: Week 24
Other outcomes:
Locations:
city: Clichy
country: France
facility: Beaujon Hospital
city: Paris
country: France
facility: Aphp St Louis
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Yoram Bouhnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Guillaume Pineton de Chambrun, MD
role: PRINCIPAL_INVESTIGATOR
References: