Loss of RESponse to Ustekinumab Treated by Dose Escalation — REScUE  

Crohn Disease Clinical Trial

Official title: Loss of RESponse to Ustekinumab Treated by Dose Escalation

Status Active, not recruiting

Clinical Trial 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

Clinical Trial Description

The study is a prospective double blind interventional study in patients with Crohn Disease treated with ustekinumab that show an objective secondary loss of response to ustekinumab after induction treatment (>Week 16). Patients can be screened during a four week period. The screening includes a clinical, biochemical and endoscopic assessment. Patients will be randomized 8 weeks after the last subcutaneous injection with ustekinumab. All patient will receive an intravenous re-induction with ustekinumab ≈6mg/kg at baseline (8 weeks after last subcutaneous administration). After the intravenous re-induction, the patients receive either ustekinumab 90 mg subcutaneous Q4W or Q8W (altered with q8w placebo to mimic Q4W injections) till week 48. Clinical and biochemical evaluation will be planned every 8 weeks until week36 with a final evaluation at week48. Primary endpoint will be assessed at week 48. Final assessment at week 48 will include clinical, biochemical and endoscopic evaluation. ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT04245215
• Study type: Interventional
• Source: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 11, 2020
• Completion date: December 2024