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Completed

NCT Number: NCT02856763

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

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.

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Key information

Conditions

CD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beaujon Hospital, Clichy, France

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About this study

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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Identification of predictive factors of adalimumab (anti TNF) failure at Week 24.

    Time frame: 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 outcomes

  1. Clinical Remission

    Time frame: Week 48

    • Clinical remission (CDAI <150 or HBI ≤ 4) at each visit until W48
  2. Monitoring of obstructive symptoms

    Time frame: 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.
  3. Evolution of items measured by MRE

    Time frame: Week 24

    Evolution of items measured by MRE between inclusion and week 24

  4. hospital stay

    Time frame: Week 48

    • Length of hospital stay.
  5. SAE

    Time frame: Week 48

    • Serious adverse events or severe infections leading to definitive treatment withdrawal.
  6. Death

    Time frame: Week 24

    Death related to CD between D0 and W24.

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study title

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

Acronym: MICA

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Aug 5, 2016
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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