Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentratio

• Conditions: Crohn's disease; MedDRA version: 16.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2013-001029-17-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-17
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Diagnosis of CD based on endoscopy and pathology
-18 years or older
-At least 6 months in remission, defined as a Harvey Bradshaw Index (HBI) score of =4
-IFX therapy > 6 months at 5 mg/kg every 8 weeks with or without concomitant immunosuppression (stable for > 3 months).
-IFX TL > 7 ug/ml.
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 224
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Non-adherence to the 8 weekly infusions schedule in the past
-Participation in another therapeutic trial
-Pregnancy
-Prior dose adjustments or interval shortening of IFX

Study & Design

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