Institutional Review Board, Hospital for Special Surgery
April 15, 2019
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.
Michael D. Lockshin, MD
Medha Barbhaiya, MD, MPH
David R. Fernandez, MD
Doruk Erkan, MD, MPH
Kyriakos A. Kirou, MD, DSc, FACP
300 patients, enrollment period will last until we reach enrollment target. We will follow patients once a year.
Inclusion: Any patient under the care of an HSS rheumatologist who has a positive ANA or a positive anti-ds DNA, anti-Ro/SS-A or other autoantibody on 2 or more occasions at least 12 weeks apart and who has one or more signs or symptoms of connective tissue disease, including but not limited to arthralgia, arthritis, myalgia, rash, sicca symptoms, pericarditis, pleuritis, pulmonary symptoms, peripheral neuropathy, photosensitivity, alopecia, oral or nasal ulcers, leucopenia, anemia, and abnormal nailfold capillaroscopy.
Exclusion: patients who meet criteria for well-defined CTD including, rheumatoid arthritis, polymyositis or dermatomyositis, systemic sclerosis, or antiphospholipid syndrome. Exclusion criteria does not include patients with SLE. Patients who are less than 18 or those unable to give informed consent in English will also be excluded. Non-English speakers will be excluded due to a lack of funds for translator services.
JoAnn Vega, CCRC