NCT02856763

Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess

Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CD

Timeline

• Start date: 2013-04-01
• Primary completion: 2020-01-01
• Completion: 2020-04-01
• First posted: 2016-08-05
• Last updated: 2021-01-20

Locations

2 sites across 1 country: France