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New treatment option for Systemic Lupus Erythematosus
Official title Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
ClinicalTrials.gov ID: NCT05799378
What this study is testing
What is Hydroxychloroquine?
Hydroxychloroquine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Any reason the treating rheumatologist is concerned about ongoing activity not captured by SLEDAI
See the full eligibility 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 ≥ 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Hackensack, New Jersey, United States; New York, New York, United States; The Bronx, New York, United States; Oklahoma City, Oklahoma, United States; Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.