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.
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.
Study Type
OBSERVATIONAL
Enrollment
125
Beaujon Hospital
Clichy, France
Aphp St Louis
Paris, France
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
Time frame: Week 24
Clinical Remission
\- Clinical remission (CDAI \<150 or HBI ≤ 4) at each visit until W48
Time frame: 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.
Time frame: Week 48
Evolution of items measured by MRE
Evolution of items measured by MRE between inclusion and week 24
Time frame: Week 24
hospital stay
\- Length of hospital stay.
Time frame: Week 48
SAE
\- Serious adverse events or severe infections leading to definitive treatment withdrawal.
Time frame: Week 48
Death
Death related to CD between D0 and W24.
Time frame: Week 24
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