Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment

• 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

Countries of recruitment

United Kingdom

Contacts

• Name: Henry
• Affiliation: Royal Liverpool University Hospital

• Name: Henry
• 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)

Primary end point(s): To determine threshold concentration of anti-TNF agents for predicting remission in patients with IBD

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

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)

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 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

Secondary ID(s)

4242