Research

Studies of Immune Deregulation in Patients with Rheumatoid Arthritis, Polymyalgia Rheumatica and Vasculitis

IRB Number: 11095

Institutional Review Board, Hospital for Special Surgery

December 14, 2012

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



Co-Investigators

Sergio Schwartzman, MD
Dana Orange, MD
Josephine Isgro, MD
Roslynn Murphy, MD
Sanjay Gupta, MD
Partha Biswas, MD
Li Song
Hairu Zou
Robert Spiera, MD
Lindsy Forbess, MD
Lindsay Lally, MD
Uma Chandrasekaran, PhD
Jessica Gordon, MD
Michela Manni, PhD
Cristina Rozo, PhD
Woelsung Yi, PhD
Weijia Yuan, MD
Uzunma Udeh
Kamini Doobay
Nina Paddu
Laura Leuenberger
Emily Ying Lai
Patricia Redcha
Edd Ricker
Nadine Spring
Alissa Tizeciak

Summary

Number of subjects to be recruited: 20 RA patients, 20 PMR patients, 20 vasculitis patients and 20 healthy controls

Enrollment period: Ongoing

Duration of follow-up: 3-4 months

Inclusion/Exclusion Criteria

Inclusion criteria
RA Patients must meet the following criteria for study entry:
-Ability and willingness to provide written informed consent
-Age >18 years
-Diagnosis of RA according to ACR criteria

PMR must meet the following criteria for study entry:
 -Ability and willingness to provide written informed consent
 -Age>50
-Diagnosis of PMR according to the modified Healey Criteria (excluding the criteria of rapid response to = 20mg of prednisone or its equivalent) without any evidence of other autoimmune diseases

Vasculitis: Examples of vasculitis include Giant Cell Arteritis (GCA), Takayasu’s Arteritis and Small Vessel Vasculitis

Takayasu’s Arteritis must meet the following criteria for study entry:
-Age>18
-Ability and willingness to provide written informed consent
-Diagnosis of Takayasu’s Arteritis according to the 1990 ACR classification criteria without any evidence of other autoimmune diseases

Anca-Associated Vasculitides:
-Age>18
-Ability and willingness to provide written informed consent
-Diagnosis of anca-vasculitis according to the 1990 ACR classification criteria without any evidence of other autoimmune diseases

Giant Cell Arteritis:
-Age>50
-Ability and willingness to provide written informed consent
-Diagnosis of giant cell arteritis according to the 1990 ACR classification criteria without any evidence of other autoimmune diseases
 
Healthy controls must meet the following criteria:
-Ability and willingness to provide written informed consent
-Age >18 years
-No diagnosis of RA or another autoimmune disease.
-No diagnosis of Raynaud’s phenomena

Exclusion criteria
-Patients with active infection (viral or bacterial) by history
-Recent trauma or surgery

Contact Information


Alessandra Pernis, MD
pernisa@hss.edu
212.606.1612
Josephine Isgro, MD
isgroj@hss.edu
212.774.2194



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