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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: 30 November 2020
Main ID:  EUCTR2019-003068-39-NL
Date of registration: 04/11/2019
Prospective Registration: Yes
Primary sponsor: UMC Utrecht
Public title: In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.
Scientific title: Withdrawal of Infliximab in patients with inflammatory bowel disease in remission guided by pharmacokinetics: WINK study - WINK study
Date of first enrolment: 20/11/2019
Target sample size: 30
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003068-39
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: observational If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Netherlands
Contacts
Name: PhD candidate   
Address:  Heidelberglaan 100 3584CX Utrecht Netherlands
Telephone:
Email: r.mahmoud-2@umcutrecht.nl
Affiliation:  UMC Utrecht
Name: PhD candidate   
Address:  Heidelberglaan 100 3584CX Utrecht Netherlands
Telephone:
Email: r.mahmoud-2@umcutrecht.nl
Affiliation:  UMC Utrecht
Key inclusion & exclusion criteria
Inclusion criteria:
Age > 18 years Diagnosis of IBD (Crohn’s Disease, Ulcerative colitis, IBD-U) Use of IFX with at >1 remaining dose scheduled after informed consent Clinical remission >6 months without IBD-related use of corticosteroids. Undetectable trough level of IFX (last available measurement) Endoscopic remission (SESCD<5 or eMayo<3) confirmed within 1 year prior to inclusion (exception possible, see protocol) Informed consent
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Planned step-up therapy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Infliximab
Product Name: Infliximab
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: not less then
Concentration number: 5-

Primary Outcome(s)
Main Objective: To determine whether the area under the curve (AUC) of the infliximab serum concentration during one infusion cycle predicts relapse within one year after drug withdrawal in IBD patients in remission
Primary end point(s): Relapse, defined as: - Endoscopical relapse (SESCD >4; eMayo 3); or - Clinical + biochemical (CRP>10 or FCP>250) relapse without endoscopy performed; or - IBD-related hospitalization, surgery; or - Occurrence of IBD-related complications (abscess, stenosis, fistula)
Secondary Objective: To determine whether the Cmax and duration of detectable infliximab concentration predict relapse within one year after drug withdrawal in IBD patients in remission
Timepoint(s) of evaluation of this end point: every 3 months until 1/2 years after withdrawal of infliximab
Secondary Outcome(s)
Secondary end point(s): Endoscopical relapse rate - Clinical + biochemical relapse rate - Occurrence of IBD related complications
Timepoint(s) of evaluation of this end point: every 3 months until 1/2 years after withdrawal of infliximab
Secondary ID(s)
Source(s) of Monetary Support
UMC Utrecht
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 20/11/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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