Stopping Hydroxychloroquine in Elderly Lupus Patients

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Recruiting Phase 3 Interventional Study
Systemic Lupus Erythematosus
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
55 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for

This trial is looking for older adults with lupus who want to see if they can safely stop taking hydroxychloroquine. Participants will be monitored for one year to check their disease activity.

Are You a Good Fit for This Trial?
Must be taking Hydroxychloroquine

You may be able to join if

  • I am at least 55 years old.
  • I have lupus and was diagnosed at least seven years ago.
  • I have been on hydroxychloroquine for at least seven years.
  • I have stable disease and meet certain medical criteria.
  • I can take oral medications.
  • I have normal eye test results within the last 6 months.
  • I am willing to follow all study procedures.
  • I have signed the informed consent form.

You may not be able to join if

  • I do not have stable disease status.
  • I have signs of eye damage.
  • I have any signs of disease activity.
  • I take more than 5 mg of prednisone daily.
  • I take any immunosuppressive drugs.
  • My doctor is concerned about my disease activity.
  • My hydroxychloroquine level is too low.
  • I have cognitive impairment or dementia.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 ≥ 55 years at time of enrollment * Normal OCT and VF assessment within 6 months of screening visit * Ability to tak…
Contacts

Mala Masson

(212) 263-0372

Mala.Masson@nyulangone.org

CONTACT