Crohn's disease Inflammatory bowel disease
Conditions
Interventions
110 subjects are randomly assigned to receive either albendazole or placebo
(1:1) in combination with continued anti-TNF treatment at unchanged dose.
Patients will receive oral albendazole treatment
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients >= 18 years and = 250 µg/g at 2 consecutive occasions (>=2 weeks and 6 (>= 4 for L1 (ileal) disease) on consecutive ileocolonoscopy 5. On anti-TNF monotherapy (ADM at a dose of 40mg Subcutaneous (SC) every week (QW) or every other week (Q2W) and IFX at a dose of approximately 5mg/kg every eight weeks) for a period of at least 6 months 6. No active combination therapy: anti-TNF + an immunomodulator (IMM). Prior use of co-therapy where IMM stopped due to stable disease, prior IMM monotherapy and prior intolerance to IMM*s are eligible 7. Therapeutic serum concentrations of anti-TNF at baseline (for IFX >= 3 µg/ml and for adalimumab (ADM) >= 5 µg/ml and undetectable levels of anti-drug antibodies (ADA*s)
Exclusion criteria
Exclusion criteria: 1. Patients 65 years old 2. Ulcerative colitis or indeterminate colitis 3. Currently ongoing malignancy 4. Women: current pregnancy wish, pregnancy or lactation. Men: active child wish 5. Use of an immunomodulator (including azathioprine, methotrexate, 6-thioguanine or 6 mercaptopurine) 6. Prior failure on anti-TNF and immunomodulatory combination therapy due to refractory disease per treating physicians opinion 7. Presence of measurable anti-drug antibodies and absence of therapeutic anti-TNF drug levels 8. Elevated liver enzymes (ALAT, ASAT, LDH, γ-GT, AF) >1.5 times the upper limit of normal (ULN) 9. Current use of any CYP3A4 inducing or inhibiting agents 10. Leukopenia (neutrophil count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with absence of ulcers on centrally read endoscopies after 12 weeks of albendazole and anti-TNF combination treatment compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients with endoscopic response on centrally read endoscopies defined as a reduction in the Simple Endoscopic Severity index (SES-CD) score by >= 50% compared to baseline 2.Proportion of patients with endoscopic remission on centrally read endoscopies defined as a SES-CD score = 70 points [CR-70]) 4.2 General and change in quality of life, as measured by the IBDQ, SF-36 and EQ-5D-5L at baseline, week 12 and 36 4.3 Patient Reported Outcome Measure (PROM): assessment of the general and change in functional status and well-being measured from the patients* perspective by the IBD-CONTROL questionnaire [25], at baseline, week 12 and 36 4.4 Occurrence of (serious) adverse events (SAE) 5. Change in Anti-TNF serum concentration and anti-drug-antibodies from baseline to W12 6. Proportion of patients with hs-CRP | — |
Countries
Netherlands
Outcome results
None listed