Status:
RECRUITING
Subcutaneous Interval Lengthening of Vedolizumab for Economic Research
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: Subcutaneous vedolizumab is an effective maintenance therapy for patients with inflammatory bowel disease. Patients using subcutaneous vedolizumab (every 2 weeks) have higher vedolizumab se...
Eligibility Criteria
Inclusion
- Diagnosis of Crohn's disease or ulcerative colitis
- Clinical and biochemical remission: absence of active inflammatory intestinal symptoms, fecal calprotectin \<250 ug/g and CRP \<5 mg/g, HBI \<5 or SCCAI \<4
- Steroid free remission for at least 6 months whilst being treated with subcutaneous vedolizumab at a stable dose of 108mg every other week.
Exclusion
- Absence of written informed consent;
- Presence of anti-drug antibodies against vedolizumab, these levels will be determined in case the vedolizumab concentration is below 1 ug/ml;
- Concomitant oral glucocorticosteroid usage;
- Imminent need for IBD-related surgery as judged by the treating clinician;
- Actively draining peri-anal fistula;
- Patients with short bowel syndrome, an ostomy or a symptomatic stricture;
- Active participation in another interventional trial;
- Pregnancy or lactation;
- Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness);
- Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy.
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06584162
Start Date
February 9 2023
End Date
February 1 2026
Last Update
September 4 2024
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, Netherlands