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SHIELD: Stopping Hydroxychloroquine in Elderly Lupus Disease
NCT05799378Phase 3
Key facts
- Status
- Recruiting
- Start
- Jun 2024
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- NYU Langone Health
- Modality
- Small Molecules
- Drugs
- hydroxychloroquine
- Conditions
- systemic lupus erythematosus (SLE)
01
Overview
Phase 3, randomised, double-blind trial in systemic lupus erythematosus (SLE) comparing Hydroxychloroquine (HCQ) with HCQ-Matching Placebo (2 arms). Primary endpoint: Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI) at 12 months. Started Jun 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hydroxychloroquine (HCQ)
Patients receive HCQ matching their enrollment dosage.
HCQ-Matching Placebo
Patients receive placebo matching their enrollment HCQ dosage.
03
Who it enrols
Patients aged 55 and older with established, stable systemic lupus erythematosus who have been taking hydroxychloroquine for at least 7 years and are not on other immunosuppressants.
04
Endpoints
Primary
Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)
Secondary
Number of Participants who Develop Moderate Flare based on rSFI
Physician Global Assessment Score
Number of Participants who Begin Prednisone Treatment
Number of Participants who Increase Prednisone Use
Number of Participants who Experience Thromboembolic Event
Number of Participants who Experience Cardiovascular Event
Number of Participants with New-Onset Diabetes
Number of Participants with New Retinal Toxicity
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