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

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

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.

Study Overview

• Status: Completed
• Conditions: CD

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.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• France
  • Clichy, France, 92110
    • Beaujon Hospital
  • Paris, France, 75410
    • APHP St Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Remission	- Clinical remission (CDAI <150 or HBI ≤ 4) at each visit until W48	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.	Week 48
Evolution of items measured by MRE	Evolution of items measured by MRE between inclusion and week 24	Week 24
hospital stay	- Length of hospital stay.	Week 48
SAE	- Serious adverse events or severe infections leading to definitive treatment withdrawal.	Week 48
Death	Death related to CD between D0 and W24.	Week 24

Collaborators and Investigators

• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: June 21, 2015
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: GETAID 2012-1; 2012-000982-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided