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Subcutaneous vedolizumab drug de-escalation in inflammatory bowel disease: a multicentre randomised controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514740-82-00
Acronym
NL83430.172.01
Enrollment
278
Registered
2025-03-20
Start date
2025-07-16
Completion date
Unknown
Last updated
2025-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Brief summary

Difference in relapse rate

Detailed description

Factors associated with successful interval extension, Proportion of patients having needed corticosteroïd treatment during follow-up, Differences in emergency visits, hospitalizations and surgery, Difference in quality of life, Cost-effectiveness of interval extension, Differences in adverse events, Vedolizumab pharmacodynamics and pharmacokinetics

Interventions

Sponsors

Stichting Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Difference in relapse rate

Secondary

MeasureTime frame
Factors associated with successful interval extension, Proportion of patients having needed corticosteroïd treatment during follow-up, Differences in emergency visits, hospitalizations and surgery, Difference in quality of life, Cost-effectiveness of interval extension, Differences in adverse events, Vedolizumab pharmacodynamics and pharmacokinetics

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026