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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004784-58-BE

Enrollment

Registered

2007-04-11

Start date

2007-06-22

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease MedDRA version: 8.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Interventions

Trade Name: remicade Product Name: remicade Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 Concentration unit: mg/kg milligram(s)/kilogram

Eligibility

Sex/Gender

All

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To study changes in the inflammatory and the fibrous component of ileal segments in patients with ileal Crohn’s disease treated with infliximab at wk 0,2,6 and q8 wks thereafter. Primary endpoint: Number of patients achieving a clinically significant change in MRI enteroclysis score of severity in Ileal Crohn’s Disease (MICD); defined as an improvement of at least 2 points and at least 50% on the inflammatory subscores. i.e. 4 to 2 or 5 to 2 or 8 to 4 (subscores defined in section 21), as measured with contrast enhanced MRI enteroclysis (procedures defined in the MRI study manual) at week 26 compared to baseline.;Secondary Objective: To study: -Clinical efficacy of infliximab in patients with ileal inflammatory stenosis based on CDAI remission and CDAI response (drop of 100 points or more). -Safety -Quality of life -predictors of response (CRP, Gd enhancement on MRI, duration of disease, con meds) -2 year resection rates ;Primary end point(s): Changes in bowel wall thickness and inflammation on contrast enhanced MRI enteroclysis at 2 weeks and 6 months compared to baseline.	—

Measure

Time frame

Main Objective: To study changes in the inflammatory and the fibrous component of ileal segments in patients with ileal Crohn’s disease treated with infliximab at wk 0,2,6 and q8 wks thereafter. Primary endpoint: Number of patients achieving a clinically significant change in MRI enteroclysis score of severity in Ileal Crohn’s Disease (MICD); defined as an improvement of at least 2 points and at least 50% on the inflammatory subscores. i.e. 4 to 2 or 5 to 2 or 8 to 4 (subscores defined in section 21), as measured with contrast enhanced MRI enteroclysis (procedures defined in the MRI study manual) at week 26 compared to baseline.;Secondary Objective: To study: -Clinical efficacy of infliximab in patients with ileal inflammatory stenosis based on CDAI remission and CDAI response (drop of 100 points or more). -Safety -Quality of life -predictors of response (CRP, Gd enhancement on MRI, duration of disease, con meds) -2 year resection rates ;Primary end point(s): Changes in bowel wall thickness and inflammation on contrast enhanced MRI enteroclysis at 2 weeks and 6 months compared to baseline.

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Countries

Belgium, France, Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026