Institutional Review Board, Hospital for Special Surgery
September 15, 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.
• 10 patients
• Screen (6 weeks)
• Treatment (22 weeks)
• Follow-up (4 weeks)
• 17 clinic visits during the 42 month study
1. Males or females age 18-75 years
2. Patients with a persistent and clinically significant aPL profile defined as:
a. Positive lupus anticoagulant (LA) test as defined by the IS TH guidelines, on 2 or more occasions, at least 12 weeks apart and/or
b. Positive anticardiolipin antibody (aCL) IgG/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart and/or
c. Positive anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart
3. Patients with at least 1 of the following non-criteria manifestations of APS:
a. aPL-nephropathy (diagnosed by kidney biopsy within 12 months of screening)
b. Skin ulcers (non-infected livedoid vasculitis-like skin ulcer and/or large skin ulceration resembling pyoderma gangrenosum)
c. Persistent thrombocytopenia (diagnosed by platelet counts < 100 /µL and ≥ 20 x 103 / µL
Exclusion Criteria (Selected) :
1. Patients with other systemic autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, etc.
2. Patients experiencing an acute thrombosis
3. Patients with skin ulcers from causes other than aPL or who are positive for Deep Vein Thrombosis.