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RecruitingPhase 3

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether people age 55 or older with stable lupus can safely stop hydroxychloroquine (HCQ), a lupus medicine. People will be assigned by chance to keep taking HCQ or take a placebo, a pill with no active medicine. They will have visits every 3 months for one year to check for lupus symptoms and flare-ups.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 55 or older.
  • Have lupus that meets accepted diagnosis rules and was diagnosed at least 7 years ago.
  • Have normal eye scans and side-vision tests within 6 months before screening.
  • Have stable lupus with no active symptoms and meet the study’s disease activity score limits.
  • Take no more than 5 mg of prednisolone daily, or an equal dose of a similar steroid, and no drugs that suppress the immune system.
  • Have had no moderate or severe lupus flare-ups in the year before screening.
  • Have taken HCQ daily for at least 7 years at the study’s required dose.
  • Sign and date a consent form, be able to take pills, and be willing and available to follow all study steps.

Who can't join

  • Lupus is not stable by the study’s rules, or the disease activity score shows active symptoms.
  • Have damage to the retina, the light-sensing layer at the back of the eye.
  • Take more than 5 mg of prednisone per day.
  • Take drugs that suppress the immune system or biologic drugs, such as rituximab or belimumab.
  • Your lupus doctor is concerned about active disease that the study’s score does not measure.
  • Have an HCQ blood level below 100 ng/mL.
  • Are unwilling or unable to follow the study steps.
  • Have signs of reduced ability to understand or make decisions, such as dementia or problems with memory or thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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)

Study sites (12)

CA

GA

NJ

NY

OK

PA