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

Conditions: Inflammatory bowel disease
MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-006084-22-GB

Lead Sponsor: Royal Liverpool University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 0

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Whether testing for antibodies against drugs is useful in patients who experience side effects from these medications;Primary end point(s): To determine threshold concentration of anti-TNF agents for predicting remission in patients with IBD;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.;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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. To better understand the patho-physiology of primary and secondary loss of response to anti-TNF agents <br>2. To determine if baseline TNF-alpha levels predict response to anti-TNF therapy<br>3. To evaluate the predictive value of earlt trough levels in sustained response to anti-TNF therapy<br>;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.