Institutional Review Board, Hospital for Special Surgery
January 31, 2014
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Based on the randomization, patients will be assigned to receive Hydroxychloroquine or no
treatment in addition to their standard regimen. The study duration is 5 years. Patients will be
followed every 6 months (unless they develop new thrombosis or pregnancy morbidity) for a
total of five years. Extensive clinical data collection will be performed once a year (unless they
develop new thrombosis and/or pregnancy morbidity). Patients will receive phone calls (month
3-9-15-21-27-33-39-45-51-57) to monitor new blood clots.
• Age 18-60
• Persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to the screening defined as:
o aCL IgG/M (> 40U, medium-to-high titer, and/or greater than the 99th percentile) and/or
o aB2GPI IgG/M (>40U, medium-to-high titer, and/or greater than the 99th percentile) and/or
o Lupus Anticoagulant test positive based on the International Society of Thrombosis & Haematosis Recommendations
Selected Exclusion Criteria
You cannot take part in this study if you have:
• History of blood clots
• History of Transient Ischemic Attack
• Lupus diagnosis
• Other Systemic Autoimmune Diseases diagnosis (e.g., Rheumatoid Arthritis, Systemic Vasculitis, Spondylarthropathy, Systemic Sclerosis, Inflammatory Muscle Disease, Sjogren Syndrome)
• Received Hydroxychloroquine within the last 3 months
• Received Warfarin (Coumadin) within the last 3 months
• Received Heparin within the last 3 months
• Current pregnancy
• Acute seizure within 7 days prior to screening
• History of Hydroxychloroquine eye toxicity
• History of Hydroxychloroquine allergy
• Known Glucose-6-phosphate dehydrogenase deficiency
• Known malignancy (with the exception of non-metastatic squamous cell and basal cell skin carcinomas)