Effect of infliximab on inflammatory and fibrous lesions in patients with intestinal Crohn’s disease - ACTIF

Phase 1

• Conditions: Crohn's disease; MedDRA version: 8.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2006-004784-58-DE
• Lead Sponsor: niversity of Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-11
• Study Completion: 2010-11-26
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Inclusion criteria
-Elevated CRP (>10 mg/L) and strong Gd uptake on baseline MRI
-age 16 to 50 yrs.
-Ileal Crohn’s disease failing immunomodulators and/or steroids for at least 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
-Significant prestenotic dilation of the ileum on baseline MRI
-Resection of more than 100 cm bowel
-Presence of abdominal abscess

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified