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.
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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 takingHydroxychloroquine
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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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 \>=55 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 3 months for one year to assess disease activity and flares.
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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…
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 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
Exclusion Criteria:
* Any patient that does not attain stable disease status by DORIS
* Ophthalmologic evidence of retinopathy (these patients would be advised to discontinue HCQ and therefore unethical to randomize for this study)
* Clinical SLEDAI \> 0
* Taking \> 5 mg/day prednisone
* Taking any immunosuppressive drugs or biological agents (including: methotrexate, azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, cyclosporine, cyclophosphamide, tacrolimus, rituximab, and belimumab)
* Any reason the treating rheumatologist is concerned about ongoing activity not captured by SLEDAI
* HCQ level \< 100 ng/ml as this would support noncompliance and less reliance on HCQ to control activity
* Patient unwilling or unable to comply with study procedures for any reason
* Any indications of potentially diminished capacity, such as a diagnosis of dementia or cognitive impairment (including, but not limited to stroke-related cognitive impairment)
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