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

• 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
• 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

Countries of recruitment

Netherlands

Contacts

• Name: Mark Löwenberg
• Affiliation: Academic Medical Center

• Name: Mark Löwenberg
• 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)

Timepoint(s) of evaluation of this end point: 24 months after randomization

Primary end point(s): Proportion of patients with sustained clinical remission

Main Objective: To evaluate the efficacy and safety of IFX dose reduction guided by serial TL measurements, compared with usual care (no dose adjustments).

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

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