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
Conditions
Interventions
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)
Sponsors
Royal Liverpool University Hospital
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: 1. Inability to consent to the study 2. Patients with IBD who are not on anti-TNF therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Contacts
Public ContactHenry
Royal Liverpool University Hospital
Outcome results
None listed