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

CD Clinical Trial

— MICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856763
• Other study ID #: GETAID 2012-1
• Secondary ID: 2012-000982-19
• Status: Completed
• Start date: April 2013
• Est. completion date: April 2020

Study information

• Verified date: January 2021
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CD
• Crohn Disease

Locations

Country	Name	City	State
France	Beaujon Hospital	Clichy
France	Aphp St Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Country where clinical trial is conducted

France, 

Outcome

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