Loss of RESponse to Ustekinumab Treated by Dose Escalation
Phase 3
Completed
NCT04245215
| Condition | Crohn Disease |
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| Phase | Phase 3 |
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| Sponsor | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW |
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| Status | Completed |
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| Enrollment | 108 participants |
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| Interventions | Ustekinumab |
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| Start date | Mar 11, 2020 |
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| Completion date | Sep 25, 2024 |
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| Results posted | Apr 13, 2026 |
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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
Proportion of Patients With Steroid Free Clinical Remission and Fecal Calprotectin<250µg/g at Week 48
week 48 · Participants
| Ustekinumab q4w | 8 Participants |
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| Ustekinumab q8w | 10 Participants |
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| p-value | 0.5 |
| Risk Difference (RD) | 0.0502 (95% CI -0.09487–0.1953) |
Open in BENITIONS
View on ClinicalTrials.gov
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