K50
Conditions
Interventions
Group 1: CD patients with previous documented loss of response to anti-TNF therapy (i.e. infliximab or adalimumab), in which retreatment is considered to be clinically useful by the treating physician
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - CD patients with previous documented loss of response to anti-TNF therapy (i.e. infliximab or adalimumab), in which retreatment is considered to be clinically useful by the treating physician and who are refractory or intolerant to conventional therapies and/or at least one other licensed class of biological therapy (including Ustekinumab or Vedolizumab) - age range 18-70 years - CD activity (stool calprotectin > 250 mg/kg and/or C-reactive protein > 5 mg/l) AND active disease as evidenced by PRO-2 [average daily abdominal pain =2 and/or stool frequency =4]).
Exclusion criteria
Exclusion criteria: • Documented allergic reactions to infliximab in the past. • Clinically significant stenosis documented by abdominal pain and small bowel distention > 3 cm in a non-affected part of the small intestine proximal to the stenosis. • Absence of bowel wall enhancement in contrast enhanced MRI or bowel ultrasound. • Severe concomitant diseases considered as contraindication for the use of anti TNF antibodies as stated in the medication’s license, such as renal insufficiency, heart failure, chronic liver disease, chronic uncontrolled infections, myelodysplasia, malignant diseases. • Complications of Crohn’s disease at high risk to require surgery (e.g. abscess, complicated fistula) or recommendation for surgery by the center’s interdisciplinary IBD board. • Evidence of latent infections as stated in the license of anti-TNF antibodies (documented exclusion of latent tuberculosis, e.g., by negative interferon gamma release assay such as Quantiferon-test, not older than 6 months; exclusion of chronic Hepatitis B virus infection within 24 months prior to inclusion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptomatic clinical response after 24 weeks after initiation of therapy as determined by a reduction of PRO-2 by > 30%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Will be analyzed after 12 and 24 weeks: • laboratory remission (defined as calprotectin <250 µg/g and normal serum concentration of C-reactive protein < 5 mg/l) • ultrasound response defined as reduction of intestinal wall thickness • Endoscopic remission (“mucosal healing”) defined as absence of major erosions/ulcers on endoscopy and histology [each optional] • Clinical remission as defined by a PRO-2 score (mean average daily SF = 2.8 and not worse than Baseline AND average daily AP score = 1 and not worse than baseline; steroid-free clinical remission defined as clinical remission without concomitant therapy with corticosteroids. • quality of life as assessed by the inflammatory bowel disease questionnaire (IBDQ) • progression of visceral sensitivity (VSI) • progression of hospital anxiety and depression (HADS-D) • progression of fatigue (FACIT-F) • need for surgery and use of corticosteroids and immunosuppressive drugs • Infliximab serum trough levels and anti-drug antibodies | — |
Countries
Germany
Contacts
Public ContactGiusi Teufel
Universitätsklinikum Freiburg
Outcome results
None listed