Systemic Lupus Erythematosus study: Hydroxychloroquine
Official title Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
ClinicalTrials.gov ID: NCT05799378
What this study is testing
What is Hydroxychloroquine?
This is an investigational oral medication being studied to see if it can be safely stopped in older patients with stable lupus. It is designed to help reduce inflammation and immune system activity in the body.
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
- This study aims to find out if it is safe to stop hydroxychloroquine in older people with stable lupus. It looks at the risk of eye damage from the drug versus the risk of their lupus getting worse.
- Who it's for
- The study is looking for people aged 55 or older who have systemic lupus erythematosus (SLE) that is currently stable.
- What's involved
- Participants will be randomly assigned to take either the real medication or a placebo (a pill with no active ingredient). They will undergo tests to check their disease activity and eye health.
- Time commitment
- The study lasts for one year, with visits required every three months.
- 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 55 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 ≥ 55 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 ≥ 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
- 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 is enrolling
- Los Angeles, California, United States
- San Diego, California, United States
- Atlanta, Georgia, United States
- Hackensack, New Jersey, United States
- New York, 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, but 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, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; San Diego, California, United States; Atlanta, Georgia, United States; Hackensack, New Jersey, United States; New York, New York, United States; Oklahoma City, Oklahoma, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.