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COMPLETED
NCT04245215
PHASE3

Loss of RESponse to Ustekinumab Treated by Dose Escalation

Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

View on ClinicalTrials.gov

Summary

The aim of the study is to investigate the effect of re-induction with ustekinumab ≈6mg/kg IV followed by two different maintenance dosing regimens 90 mg subcutaneous every 8 weeks (Q8W) vs 90 mg subcutaneous every 4 weeks(Q4W) on clinical, biological and pharmacological outcomes in patients with Crohn's disease who show a secondary loss of response over time

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2020-03-11

Completion Date

2024-09-25

Last Updated

2026-07-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ustekinumab

re-induction and dose escalation form every 8 weeks to every 4 weeks only in arm 2

Locations (1)

Ingrid Arijs

Zaventem, Belgium