The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control… (NCT06504420) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study
70 participantsStarted 2024-10-15
Plain-language summary
This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphospholipid syndrome patients at week 24 and week 48.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Understand and sign the informed consent form
. Male or Female
. aged 18-70 at the time of screening visit
. Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS
. With the stable combination therapy
Exclusion criteria
. history of serious adverse events or contraindication to Sirolimus
. Catastrophic APS within 90 days
. Acute thrombosis within 30 days
. ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases
. Historically positive HIV test or test positive at screening for HIV
. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.