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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Age ≥ 60 years at time of enrollment

• Normal OCT and VF assessment within 6 months of screening visit

• Ability to take oral medication

• Have established SLE (≥ 4 ACR criteria or SLICC criteria or ≥ 10 points by EULAR criteria, SLE diagnosed at least seven years ago)

• Stable disease at screening visit by attaining DORIS remission (meeting all criterion listed below) and not on any immunosuppressants.

‣ Criterion 1: Clinical SLEDAI= 0

⁃ Criterion 2: SELENA-SLEDAI PGA ≤ 0.5 (on a scale from 0-3, where 0 is no disease activity and 3 is maximum disease activity)

⁃ Criterion 3: Current prednisolone (or equivalent corticosteroid) dose ≤ 5 mg daily

• No moderate or severe flares one year prior to screening

• Taking ≥ 200 HCQ daily for ≥ 7 years

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
New Jersey
Hackensack Meridian Health
RECRUITING
Hackensack
New York
Columbia University Irving Medical Center/New York Presbyterian
RECRUITING
New York
Hospital for Special Surgery
RECRUITING
New York
NYC Health + Hospitals/Bellevue
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
VA NY Harbor Healthcare System
RECRUITING
New York
Montefiore Medical Center/Albert Einstein College of Medicine
RECRUITING
The Bronx
Oklahoma
Oklahoma Medical Research Foundation
RECRUITING
Oklahoma City
Pennsylvania
Penn State MS Hershey Medical Center
RECRUITING
Hershey
Contact Information
Primary
Mala Masson
Mala.Masson@nyulangone.org
(212) 263-0372
Time Frame
Start Date: 2024-06-27
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 330
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov