Crohn's Disease Endoscopic REmission Definition in an Objective Way
NCT03498625
CD
Leuven, Belgium
View Trial DetailsNCT Number: NCT02856763
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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Notify Me18 year and older
All sexes
Observational
Beaujon Hospital, Clichy, France
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 :
Supportive care including artificial nutrition will be started if necessary.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Week 48
Time frame: Week 48
Time frame: Week 24
Evolution of items measured by MRE between inclusion and week 24
Time frame: Week 48
Time frame: Week 48
Time frame: Week 24
Death related to CD between D0 and W24.
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Other
Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study
Acronym: MICA
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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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