Research

A Study of Novel Immune Modulating Biomarkers in Patients with Spondyloarthritis with Axial Involvement

IRB Number: 12174

Institutional Review Board, Hospital for Special Surgery

November 07, 2013

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

Vivian P. Bykerk, MD

Co-Investigators

Susan M. Goodman, MD
Lisa A Mandl, MD
Mary K. Crow, MD
Caroline E. Reidy, MPH

Summary

Observational study of 70 subjects over a 2 year period.

Inclusion/Exclusion Criteria

Inclusion Criteria:
 Patients with SpA should have a BASDAI of > 4 without MRI or radiographic evidence of Sacroiliitis
 Patients with MRI or radiographic evidence of Sacroiliitis should have a BASDAI of >3.5 
 No biologic therapy for 3 months.  Patients may have had a TNFi > 3 months prior to study entry, but patients currently receiving, for example, adalimumab, etanercept, infliximab, golimumab, certolizumab pegol or who have taken any TNFis  within the previous 3 months are ineligible.
  =18 yrs old 
 Diagnosis of Spondyloarthritis (SpA) (per ASAS criteria and having sacroillitis as confirmed by radiographs or MRI at baseline), with psoriatic arthritis (PsA) (per the ASAS or CASPAR criteria).  See Appendix for ASAS and CASPAR Criteria). 
 Patients must have evidence of sacroillitis either by radiograph or MRI, or must have evidence of spine inflammation confirmed by radiographs or spine MRI
Exclusion Criteria:
  Age < 18
 Diagnosis of a systemic rheumatic disease or crystalline arthritis (i.e. RA, SLE, systemic sclerosis, gout, pseudogout, Lyme arthritis, reactive arthritis, viral arthritis)
 Pregnant or nursing
 Unable to give informed consent
 Lack of fluency in English.  Unfortunately, we do not have the financial resources to offer full translation services
 Unwilling or unable to be followed as part of routine care
 Patients currently receiving  biologic therapy (e.g. adalimumab, etanercept, infliximab, golimumab, certolizumab pegol)

Contact Information

Caroline Reidy, MPH
reidyc@hss.edu
646.714.6307



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