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Anti-malarial drug
Stopping Hydroxychloroquine for Lupus (SHIELD Trial)
Phase 3
Waitlist Available
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
SHIELD Trial Summary
This trial will look at if it is safe to stop taking Hydroxychloroquine (HCQ) for SLE in older patients, measuring risk of flare-ups, side effects, and disease activity.
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.Check my eligibility
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.See study design
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.
SHIELD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)
Secondary outcome measures
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 Begin Prednisone Treatment
+7 moreSide effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
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%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
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)
SHIELD 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
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,520 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,268 Total Patients Enrolled
Peter IzmirlyPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 years old or older.My disease has not stabilized according to DORIS.My HCQ level is below 100 ng/ml, indicating I haven't been relying on it.I am taking more than 5 mg of prednisone daily.I have been diagnosed with dementia or cognitive impairment.I am willing and able to follow the study's procedures.My lupus is currently active.I am not taking any drugs that weaken my immune system.I have been diagnosed with lupus for at least 7 years.I can take pills by mouth.My lupus is stable, I'm not on strong meds, and I've been taking HCQ for over 7 years.I have been taking 200 or more HCQ daily for at least 7 years.
Research Study Groups:
This trial has the following groups:- Group 1: Hydroxychloroquine (HCQ)
- Group 2: HCQ-Matching Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are managing this experiment?
"Currently, this medical trial has 10 different sites that are welcoming participants. These include locations in Hackensack, Bronx and New york City with an additional 7 other respective centres. To limit the need for travel it is essential to select a local clinic if you wish to join the study."
Answered by AI
What safety assessments have been taken with regard to HCQ use?
"Hydroxychloroquine (HCQ) has demonstrated an acceptable level of safety in the context of this Phase 3 trial, warranting a score of 3. Multiple studies have produced evidence to support its efficacy and security."
Answered by AI
Are any individuals being sought for participation in this clinical trial presently?
"According to the information found on clinicaltrials.gov, this trial is not currently seeking participants and was last updated on March 23rd 2023. Despite its inactivity, there are 135 other trials that have open recruitment periods at present."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have been on plaquenil over 20+ years.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is clinical trials and what is all the information about this trial?
PatientReceived no prior treatments
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