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RECRUITING
NCT05799378
PHASE3

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2024-06-27

Completion Date

2029-06-30

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DRUG

Hydroxychloroquine

Hydroxychloroquine 200mg capsules. Administered orally.

DRUG

Placebo

Hydroxychloroquine-matching placebo capsule. Administered orally.

Locations (10)

University of California, Los Angeles

Los Angeles, California, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

VA NY Harbor Healthcare System

New York, New York, United States

NYC Health + Hospitals/Bellevue

New York, New York, United States

NYU Langone Health

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Columbia University Irving Medical Center/New York Presbyterian

New York, New York, United States

Montefiore Medical Center/Albert Einstein College of Medicine

The Bronx, New York, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Penn State MS Hershey Medical Center

Hershey, Pennsylvania, United States