engthening of vedolizumab injections based on drug concentrations in patients with inflammatory bowel disease

Phase 1

• Conditions: Inflammatory bowel diseases (Crohn's disease, ulcerative colitis); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2022-000837-17-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-29
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

?Age 18 or older;
?Diagnosis of CD or UC;
?Clinical and biochemical remission, all three criteria below need to be fulfilled prior to enrolment:
?Absence of active inflammatory intestinal symptoms, as judged by both patient and physician;
?FCP <250 µg/g and CRP <5 mg/L;
?HBI <5 (CD) or SCCAI <4 (UC).
?Steroid-free remission for =6 months whilst being treated with SC vedolizumab at a stable dose (108 mg every 2 weeks);
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

?Absence of written informed consent;
?Presence of anti-drug antibodies against vedolizumab;
?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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified