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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 14 April 2014
Main ID:  EUCTR2013-001029-17-NL
Date of registration: 17/05/2013
Prospective Registration: Yes
Primary sponsor: Academic Medical Center
Public title: Dose reduction of infliximab in Crohn’s disease, based on serum infliximab concentration
Scientific title: Efficacy and safety of trough level-based dose reduction during infliximab maintenance treatment in Crohn’s disease - REDIX
Date of first enrolment: 01/04/2014
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001029-17
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: A different infliximab treatment schedule according to standard practice. Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: Mark Löwenberg   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: +31205667621
Email: m.lowenberg@amc.uva.nl
Affiliation:  Academic Medical Center
Name: Mark Löwenberg   
Address:  Meibergdreef 9 1105 AZ Amsterdam Netherlands
Telephone: +31205667621
Email: m.lowenberg@amc.uva.nl
Affiliation:  Academic Medical Center
Key inclusion & exclusion criteria
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease
MedDRA version: 16.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Remicade
Product Name: Infliximab
Pharmaceutical Form: Powder for concentrate for solution for infusion

Primary Outcome(s)
Main Objective: To evaluate the efficacy and safety of IFX dose reduction guided by serial TL measurements, compared with usual care (no dose adjustments).
Primary end point(s): Proportion of patients with sustained clinical remission
Secondary Objective: Compare the time to relapse
To identify predictors allowing selection of patients in whom dose reduction is easier and more successful using a logistic regression analysis
Compare laboratory tests (CRP and fecal calprotectin) at all study visits
Compare adverse events
To investigate whether gradual dose reduction results in a significant reduction of the per patient annual cost of IFX maintenance treatment
Pharmaco-economic evaluation
Timepoint(s) of evaluation of this end point: 24 months after randomization
Secondary Outcome(s)
Secondary end point(s): Proportion of patients with clinical and biochemical relapse; Time to relapse; Presence of predictive factors for successful dose reduction with specific focus on smoking status, body mass index and extent of disease; Laboratory tests (CRP and fecal calprotectin) at all study visits; Adverse events; Yearly cost of IFX treatment in the intervention versus the control group; Pharmaco-economic evaluation.
Timepoint(s) of evaluation of this end point: 24 months after randomization
Secondary ID(s)
REDIX
Source(s) of Monetary Support
Academic Medical Center
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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