Luminal Crohns Disease, moderate to severe, refractory to steroids and/or antimetabolitets and controlled with anti-TNF therapy MedDRA version: 8.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Interventions
Trade Name: HUMIRA
Pharmaceutical Form: Injection*
Trade Name: REMICADE
Pharmaceutical Form: Intravenous infusion
Sponsors
University of Leuven, Division of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women of 18 years and older willing and able to give written informed consent. 2. Patients in clinical remission and/or complete response (as judged by the investigator) (CDAI=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients receiving infliximab doses exceeding 5 mg/kg 2. Incomplete response to infliximab (CDAI>200) 3. Pregnant or lactating women. Men and women of childbearing potential should use a effective double barrier method for contraception. 4. Patients with intercurrent medical conditions or laboratory abnormalities that preclude further administration of anti-TNF agents such as demyelinating diseases or severe heart failure. 5. Patients with an imminent need for surgery such as those with a symptomatic fibrotic stricture. 6. Patients with a draining abdominal enterocutaneous fistula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate in a randomized comparative cohort study if patients in clinical remission or full response on infliximab maintain in remission when changed to systematic adalimumab therapy compared to maintenance infliximab and to enquire about their preferred treatment strategy. Primary endpoint: The proportion of patients in clinical remission defined as a CDAI<150. ;Secondary Objective: 1. The median numbers of flares experienced while patients are in the study. A flare will be defined as an increase in CDAI of 100 points above baseline (and more than 150). 2. The proportion of patients needing rescue therapy with short courses or oral corticosteroids and the median number of steroid courses in both groups or switch to another anti-TNF agent. 3. The proportion of patients who develop injection-site or infusion related reactions and require institution of prophylactic treatment for infusion related reactions while in the study. 4. Quality of life assessment based on the disease specific IBD Questionaire (IBDQ) and patient preference based on a newly developed questionnaire. (appendix 1). 5. The median number of infusion-related or injection-site related reactions. 6. The occurrence of adverse events 7. The change in antibody status and trough levels for adalimumab and infliximab after the infusion or injection ;Primary end point(s): The proportion of patients in clinical remission defined as a CDAI<150 at 54 weeks | — |
Countries
Belgium
Outcome results
None listed