CD
Conditions
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.
Interventions
None listed
Sponsors
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of predictive factors of adalimumab (anti TNF) failure at Week 24. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring of obstructive symptoms | Week 48 | \- 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. |
| Evolution of items measured by MRE | Week 24 | Evolution of items measured by MRE between inclusion and week 24 |
| Clinical Remission | Week 48 | \- Clinical remission (CDAI \<150 or HBI ≤ 4) at each visit until W48 |
| SAE | Week 48 | \- Serious adverse events or severe infections leading to definitive treatment withdrawal. |
| Death | Week 24 | Death related to CD between D0 and W24. |
| hospital stay | Week 48 | \- Length of hospital stay. |
Countries
France
Outcome results
None listed