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

NCT02856763 | Completed

• 2 other identifiers: GETAID 2012-12012-000982-19
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

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.

Conditions

CD

Outcome Measures

Primary Outcomes (1)

• 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

  Week 24

Secondary Outcomes (6)

• Clinical Remission

  Week 48

• Monitoring of obstructive symptoms

  Week 48

• Evolution of items measured by MRE

  Week 24

• hospital stay

  Week 48

• SAE

  Week 48

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead

Study Sites (2)

Beaujon Hospital

Clichy, 92110, France

Location

Aphp St Louis

Paris, 75410, France

Location

Related Publications (1)

• 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.

  PMID: 36731588 DERIVED

Study Officials

• Yoram Bouhnik, MD

  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  PRINCIPAL INVESTIGATOR

• Guillaume Pineton de Chambrun, MD

  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2015
• First Posted: August 5, 2016
• Study Start: April 1, 2013
• Primary Completion: January 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 20, 2021

Record last verified: 2021-01

Locations

FR (2)