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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: 16 October 2012
Main ID:  EUCTR2011-006084-22-GB
Date of registration: 15/08/2012
Prospective Registration: Yes
Primary sponsor: Royal Liverpool University Hospital
Public title: Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment
Scientific title: Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease
Date of first enrolment: 04/10/2012
Target sample size: 0
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006084-22
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: Henry    
Address:  Research & Development Department L7 8XP 4th Floor Linda McCartney Centre United Kingdom
Telephone: 01517063321
Email: Carl.Henry@rlbuht.nhs.uk
Affiliation:  Royal Liverpool University Hospital
Name: Henry    
Address:  Research & Development Department L7 8XP 4th Floor Linda McCartney Centre United Kingdom
Telephone: 01517063321
Email: Carl.Henry@rlbuht.nhs.uk
Affiliation:  Royal Liverpool University Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
1. Patients with an established diagnosis of IBD (Crohn's disease or ulcerative colitis) who are already on treatment or being initiated on treatment with anti-TNF agents
2. Patients who experience an adverse event with infliximab or adalimumab
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
1. Inability to consent to the study
2. Patients with IBD who are not on anti-TNF therapy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Inflammatory bowel disease
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1 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: Infusion
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Current Sponsor code: Centocor
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 10mg/kg body wt-

Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Current Sponsor code: EU/1/03/256/001
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number: 40-mg

Primary Outcome(s)
Main Objective: To investigate if testing trough levels of infliximab and adalimumab and anti-drug antibodies against infliximab and adalimumab adds value to the treatment of patients with inflammatory bowel disease
Primary end point(s): To determine threshold concentration of anti-TNF agents for predicting remission in patients with IBD
Secondary Objective: 1. Whether it is possible to predict the long term response to treatment to infliximab and adalimumab by measuring trough levels early on in the treatment course
2. Whether testing for antibodies against drugs is useful in patients who experience side effects from these medications
Timepoint(s) of evaluation of this end point: This is a cross sectional study and will aim to recruit existing patients on maintenance anti-TNF therapy. We expect recritment to last for 12 months and data analysis a further 6 months.
Secondary Outcome(s)
Secondary end point(s): 1. To better understand the patho-physiology of primary and secondary loss of response to anti-TNF agents
2. To determine if baseline TNF-alpha levels predict response to anti-TNF therapy
3. To evaluate the predictive value of earlt trough levels in sustained response to anti-TNF therapy
Timepoint(s) of evaluation of this end point: The patient population for the secondary end points will be mainly comprised of new initiators who will be longitudinally followed up for 12 months after initiation of therapy. We will aim to recruit all new initiators to this study and follow them up for a further 12 months. Thus, this aspect of the study will last 24 months.
Secondary ID(s)
4242
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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