Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
NYU Langone Health
Study ID
NCT05799378
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hydroxychloroquine — DRUG
    Hydroxychloroquine 200mg capsules. Administered orally.
  • Placebo — DRUG
    Hydroxychloroquine-matching placebo capsule. Administered orally.

Study Details

Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use. Evaluation using sensitive standard of care approaches suggests nearly a third of patients accrue retinal damage. Data are needed to accurately weigh the balance between accumulating ocular exposure of HCQ versus the risk of disease flare in a population that may have more inactive disease than younger patients. The purpose of this trial is to address the safety of withdrawal of HCQ in SLE patients =60 years old. The central hypothesis is that HCQ can be safely discontinued in stable/quiescent patients assessed by validated disease activity and flare instruments in the context of serologic, cytokine and transcriptomic profiling. Patients will be randomized to either the placebo or active arm and followed every 2 months for one year to assess disease activity and flares.

Key Dates

Start date
Jun 27, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
330 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hydroxychloroquine (HCQ)
    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.
  • Placebo Comparator: HCQ-Matching Placebo
    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.

Primary Outcome Measure

Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI) [ Time Frame: Up to Month 12 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-
Hackensack Meridian HealthHackensackNew Jersey07601-
Columbia University Irving Medical Center/New York PresbyterianNew YorkNew York10032-
Hospital for Special SurgeryNew YorkNew York10021-
NYC Health + Hospitals/BellevueNew YorkNew York10016-
NYU Langone HealthNew YorkNew York10016-
VA NY Harbor Healthcare SystemNew YorkNew York10010-
Montefiore Medical Center/Albert Einstein College of MedicineThe BronxNew York10461-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-
Penn State MS Hershey Medical CenterHersheyPennsylvania17033-

Find similar trials in Los Angeles, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
University of California, Los Angeles· Los Angeles, CAHackensack Meridian Health· Hackensack, NJColumbia University Irving Medical Center/New York Presbyterian· New York, NYHospital for Special Surgery· New York, NYNYC Health + Hospitals/Bellevue· New York, NYNYU Langone Health· New York, NY

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