Research

Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry38880

IRB Number: 11096

Institutional Review Board, Hospital for Special Surgery

July 08, 2011

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.

Principal Investigator

Thomas J.A. Lehman, MD

Summary

This is a registry involving standard of care treatment and questionnaires at each office visit. We anticipate approximately 800 patients from this site. Patients will be followed approximately twice a year as long as they continue under care at this site.

Inclusion/Exclusion Criteria

Inclusion Criteria:

All patients must meet the designated diagnostic or classification criteria for at least one of the diseases listed below in order to be approached to be in this registry protocol.

The defined pediatric rheumatic diseases include:

  • juvenile idiopathic arthritis (JIA),
  • systemic lupus erythematosus (SLE)/mixed connective tissue disease (MCTD),
  • juvenile dermatomyositis (JDM),
  • localized scleroderma (LS),
  • systemic sclerosis (SSc),
  • vasculitis,
  • sarcoidosis, and
  • juvenile primary fibromyalgia syndrome (JPFS).
  • Subjectís age at time of consent is 21 years or younger, with onset of rheumatic disease prior to age 16 years. Patents are sometimes followed at the site beyond the age of 21. Those lost to adult care will not continue to be followed at our site for the CARRA registry. It is unlikely that a new patient would be lost to adult care, however, since new patients are rarely 21 years old.
  • Subject has been diagnosed with a defined pediatric rheumatic disease including: JIA, SLE/MCTD, JDM, SS, LS, vasculitis, sarcoid or JPFS according to published criteria .
  • Person providing consent must be able to read either English or Spanish.
  • Subject (and/or parent/legal guardian) is able to provide informed consent and willing to comply with study procedures.

 Exclusion Criteria:

 Subject/legal guardian is unwilling to provide contact information for one or more individuals outside the subjectís primary residence who are likely to be in contact with the subject/parent/parent or guardian and are willing to be contacted in the event study staff cannot make contact with the subject and/or parent/guardian

Contact Information


Chahait Singh, BS
SinghC@hss.edu
212.606.1151



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