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Anti-malarial drug

Stopping Hydroxychloroquine for Lupus (SHIELD Trial)

Phase 3
Recruiting
Led By Peter Izmirly
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
Pivotal Trial

Summary

This trial is testing if older lupus patients can safely stop taking Hydroxychloroquine, a drug that reduces lupus symptoms but can harm the eyes over time. The study focuses on patients aged 60 and above who have stable disease. Researchers will monitor these patients for an extended period to see if their condition remains stable without the drug.

Who is the study for?
This trial is for stable/quiescent elderly patients (60+ years) with systemic lupus erythematosus who've been on Hydroxychloroquine (≥200mg daily) for at least 7 years. They must have no recent severe flares, be able to take oral meds, and show no retinal damage. Those on high-dose steroids or immunosuppressants are excluded.
What is being tested?
The study tests the safety of stopping Hydroxychloroquine in older adults with inactive lupus by comparing it against a placebo. Participants will be randomly assigned to either continue HCQ or switch to a placebo and monitored bi-monthly for a year to track disease activity.
What are the potential side effects?
While not explicitly stated, potential side effects may include increased risk of lupus flare-ups after stopping Hydroxychloroquine. Regular medication can cause eye issues over time but this trial focuses on safely discontinuing treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)
Secondary study objectives
Change in 29-Question Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
Change in 36-Item Short Form Survey Instrument (SF-36) Score
Number of Participants who Develop Moderate Flare based on rSFI
+2 more

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250
13%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Wolff-Parkinson-White syndrome
1%
Coronary artery occlusion
1%
Anaemia
1%
Leukopenia
1%
Lumbar spinal stenosis
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hydroxychloroquine (HCQ)Experimental Treatment1 Intervention
Patients will receive a 90-day supply of HCQ at their screening visit, at 2 months, 4 months, 6 months, 8 months, and 10 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ dose administered will match each patient's dosage of HCQ at enrollment.
Group II: HCQ-Matching PlaceboPlacebo Group1 Intervention
Patients will receive a 90-day supply of HCQ-matching placebo at their screening visit, at 2 months, 4 months, 6 months, 8 months, and 10 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ-matching placebo dose administered will match each patient's dosage of HCQ at enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
2017
Completed Phase 4
~5360

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hydroxychloroquine, a cornerstone treatment for systemic lupus erythematosus (SLE), works by modulating the immune system. It inhibits toll-like receptors (TLRs) on plasmacytoid dendritic cells, reducing the activation of these cells and subsequent production of interferon, a key driver of inflammation in Lupus. This mechanism helps decrease disease activity and prevent flares. Other common treatments include corticosteroids, which reduce inflammation by suppressing the immune response, and immunosuppressants like methotrexate, which inhibit the proliferation of immune cells. Understanding these mechanisms is crucial for Lupus patients as it highlights the importance of these medications in controlling the disease and preventing organ damage. In the context of hydroxychloroquine withdrawal, knowing its role in immune modulation helps patients and doctors weigh the risks of discontinuation against potential benefits, such as reducing the risk of retinal toxicity.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,796 Previous Clinical Trials
8,140,104 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,400 Previous Clinical Trials
854,619 Total Patients Enrolled
Peter IzmirlyPrincipal InvestigatorNYU Langone Health

Media Library

Hydroxychloroquine (Anti-malarial drug) Clinical Trial Eligibility Overview. Trial Name: NCT05799378 — Phase 3
Lupus Research Study Groups: Hydroxychloroquine (HCQ), HCQ-Matching Placebo
Lupus Clinical Trial 2023: Hydroxychloroquine Highlights & Side Effects. Trial Name: NCT05799378 — Phase 3
Hydroxychloroquine (Anti-malarial drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05799378 — Phase 3
~220 spots leftby Dec 2028