Patients with Crohn's disease with absence of disease activity during biologic therapy (infliximab) MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/ki
Sponsors
Department of medical gastroenterology S, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Primary inclusion criteria: • Luminal Crohn's disease defined according to standardized diagnostic criteria. • Age = 18 years. • IFX treatment length minimum 12 months (minimum 365 days from first IFX administration to last IFX administration prior to inclusion). Episodic therapy with IFX pause > 12 weeks is not accepted within the last year. The treatment interval in the last three months has to be of 6-10 weeks. • Complete remission defined as: o Crohn’s Disease Activity Index (CDAI) score =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Primary exclusion criteria: • Initial indication for IFX being predominantly fistulizing perianal disease. • Active fistulizing perianal disease. • Any contraindications for continuing IFX treatment, including prior acute or delayed infusion reaction to a TNF- inhibiting agent, any active infection requiring parenteral or oral antibiotic treatment, known infection with tuberculosis, human immunodeficiency virus (HIV) or hepatitis virus. • Any condition including physician finds incompatible with participation in the study or the patient being unwilling or unable to follow protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to investigate if infliximab (IFX) can safely and favourably be discontinued in patients with Crohn's disease in sustained complete remission on IFX maintenance therapy. ;Secondary Objective: Further we will examine the clinical utility of measuring levels/activity of IFX and activity of anti-IFX Ab in patients in sustained complete remission, in order to investigate whether pharmacoimmunological data can predict the clinical outcome and rationalize therapeutic management of these patients with respect to continuation or discontinuation of IFX therapy. Additional, we will investigate the optimal time-point, out of three, to measure this activity.;Primary end point(s): Primary endpoint The primary endpoint of this study is the proportion of patients who maintain remission, i.e. CDAI <150. ;Timepoint(s) of evaluation of this end point: This endpoint is assessed at 48 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints Patients who continue IFX and patients who discontinue IFX are compared with respect to the following at 48 weeks after inclusion: • Proportion of patients who maintain complete remission. • Proportion of patients experiencing relapse. • The proportion of patients, who are no longer in remission, but are not in relapse. • Median time to relapse after discontinuation of IFX. • Change from baseline in disease activity evaluated by: CDAI as assessed by CDAI score, quality of life (QoL) as assessed by short-IBDQ, work productivity and activity as assessed by WPAI, biochemical markers assessed by, i.e. C-reactive protein (CRP), platelets, white blood cell (WBC) count, Hemoglobin (Hb) and fecal calprotectin and colonoscopy (scored by the SES-CD) / MR imaging. • Economical expenses in the to groups.;Timepoint(s) of evaluation of this end point: Endpoints are assessed at 48 weeks | — |
Countries
Denmark, Finland, Norway, Sweden
Contacts
Public ContactSine Buhl
Department of medical gastroenterology, Herlev Hospital
Outcome results
None listed