Rheumatology Clinical Research Center (RCRC)

The RCRC at the Hospital for Special Surgery under the Division of Rheumatology is comprised of rheumatologists with strong interests and expertise in epidemiological, health services, and outcomes research in various rheumatic diseases.

The goal of the RCRC is to design and execute scientifically sound clinical studies that are important to clinical rheumatology and the care of patients.

RCRC Faculty (in alphabetical order; click name for physician profile):

Doruk Erkan, MD	Recent Publications
Allan Gibofsky MD, JD	Recent Publications
Michael D. Lockshin, MD	Recent Publications
Lisa A. Mandl, MD, MPH	Recent Publications

Current RCRC Educational Programs:

1. Clinical Research Mentorship for Rheumatology Fellows, Medical Residents and Medical Students

   Current HSS Rheumatology Fellows with Active RCRC Projects:

   • Krishna Chaganti, MD Mentor: Lisa A. Mandl, MD, MPH
   • Lisa Varley, MD Mentor: Michael D. Lockshin, MD
   • Juliet Aizer, MD, MPH Mentor: Melanie J. Harrison, MD, MS
   • Sheila Angeles, MD Mentor: Melanie J. Harrison, MD, MS

2. Epidemiology of Rheumatic Diseases Journal Club
   • Time: Tuesdays, 11 AM
   • Location: Research Building 3^rd floor Conference Room
   • Moderators: Melanie J. Harrison, MD, MS, Lisa A. Mandl, MD, MPH

3. Application of Clinical Research Methods in Rheumatology
   • Time: Thursdays, 8 AM (summer)
   • Location: Belaire Building, Suite: 9F
   • Instructor: Melanie J. Harrison, MD, MS

4. Visiting Scholars Program in Clinical Research for Selected Experts
   • Time: Throughout the academic year selected rheumatology experts are invited to provide lectures and interact with HSS faculty.
   • Location: HSS
   • Directors: Stephen A. Paget, MD, Melanie J. Harrison, MD, MS, Lisa A. Mandl, MD, MPH

1. Cognitive Function in Lupus and Primary Antiphospholipid Syndrome Patients over Time
   • An ongoing, observational investigation of lupus patients designed to identify cognitive dysfunction and factors associated with it
   • Sponsors: Arthritis Foundation (New York Chapter and National Office), Mary Kirkland Center for Lupus Research, NIAMS
   • Principal Investigator: Melanie J. Harrison, MD, MS
   • RCRC Co-investigators: Michael D. Lockshin, MD and Doruk Erkan, MD
   • HSS IRB #: 97054

2. APSCORE: National Antiphospholipid Syndrome Collaborative Registry
   • National registry that collects clinical and laboratory information on patients with antiphospholipid antibodies and/or syndrome.
   • Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
   • Principal Investigator: Robert Roubey, MD (University of North Carolina at Chapel Hill)
   • HSS Investigators: Michael D. Lockshin, MD and Lisa Sammaritano, MD
   • HSS Co-investigator: Doruk Erkan, MD
   • HSS IRB #: 20067

3. APLASA Study: Determining the Role of Aspirin for Thrombosis Prophylaxis in Antiphospholipid Syndrome
   • An international multi-center, randomized, placebo (sugar tablet) controlled study designed to study whether low-dose aspirin can prevent blood clots in asymptomatic aPL-positive individuals (those who only have the antibodies but have never had a clot)
   • Sponsors: Bayer Pharmaceuticals, Arthritis Foundation (New York Chapter)
   • Principal Investigator: Doruk Erkan, MD
   • HSS Co-investigators: Melanie J. Harrison MD, MS, Michael D. Lockshin, MD, Lisa Sammaritano, MD, and Margaret Peterson, PhD
   • HSS IRB #: 20068

4. APLASA-P Study: Determining the Role of Aspirin in the Management of Antiphospholipid Syndrome Patients who Present Only with Pregnancy Morbidity
   • An international multi-center, observational study designed to study whether low-dose aspirin can prevent blood clots in APS patients who have only had miscarriages but no blood clots in other vessels
   • Sponsors: Bayer Pharmaceuticals, Arthritis Foundation, New York Chapter
   • Principal Investigator: Doruk Erkan, MD
   • HSS Co-investigators: Melanie J. Harrison MD, MS, Michael D. Lockshin, MD, Lisa Sammaritano, MD, Margaret Peterson, PhD
   • HSS IRB #: 20069

5. Rheumatoid Arthritis (RA) Clinical Research Registry: RA Clinical Evaluation and Response System (RACER)
   • Ongoing clinical database of all rheumatoid arthritis patients seen at the Hospital for Special Surgery to determine their long-term outcomes and predictors of these outcomes
   • Sponsor: Hospital for Special Surgery, Department of Medicine
   • Principal Investigator: Melanie J. Harrison, MD, MS
   • HSS Co-investigator: Stephen A. Paget, MD
   • HSS IRB #: 21017

6. Characterization of Fatigue in Rheumatic Disease
   • Comparison of the quality and quantity of fatigue in several rheumatic diseases including systemic lupus erythematosus and rheumatoid arthritis
   • Sponsor: Arthritis Foundation (New York Chapter)
   • Principal Investigator: Melanie J. Harrison, MD, MS
   • HSS Co-investigator: Stephen Paget, MD
   • HSS IRB #: 21047

7. Identifying Unexplored Domains of Quality of Life in Lupus Patients
   • Study to identify facets of daily life that have been impacted upon by lupus that are not routinely evaluated in studies of quality of life in adults with lupus
   • Sponsors: Mary Kirkland Center for Lupus Research
   • Principal Investigator: Melanie J. Harrison, MD, MS
   • HSS IRB #: 21067

8. A Pilot Study of a Cognitive Rehabilitation Intervention Program in Systemic Lupus Erythematosus (SLE) Patients
   • Study of a novel group educational program for lupus patients to improve their ability to perform everyday tasks that have become difficult due to cognitive dysfunction
   • Sponsor: Mary Kirkland Center for Lupus Research
   • Principal Investigator: Melanie J. Harrison, MD, MS
   • HSS IRB #: 22076

9. An Open Label Pilot Trial for the Treatment for Carpometacarpal Osteoarthritis
   • This study is evaluating the effectiveness of Synvisc, a treatment approved for knee arthritis, for treating arthritis at the base of the thumb
   • Sponsors: Wyeth Pharmaceuticals, National Institute of Health
   • Principal Investigator: Lisa A. Mandl MD, MPH
   • HSS IRB #: 23034

10. Quality of Life in Pediatric SLE

    • Study to determine what characteristics of childhood lupus are associated with decreased quality of life
    • Sponsors: Hospital for Special Surgery, Department of Pediatrics
    • Principal Investigator: Lakshimi Moorthy, MD and Thomas Lehman, MD
    • Co-investigators: Melanie J. Harrison, MD, MS, Margaret Peterson, PhD

11. LCTC: Lupus Clinical Trials Consortium HSS Clinical Lupus Registry
    • A clinical registry of systemic lupus erythematosus (SLE) patients that is created by the Department of Rheumatology at HSS for LCTC multicenter clinical lupus studies
    • Sponsor: Lupus Clinical Trials Consortium
    • Clinical Director: Doruk Erkan, MD
    • Center Director: Michael D. Lockshin, MD
    • HSS co-investigator: Melanie J. Harrison, MD
    • HSS IRB #: 24023

12. CORRONA Data Collection Program
    • CORRONA is a clinical registry which aims to provide physicians with a better understanding of the course of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and which treatments work best for patients
    • Sponsor: The Consortium of Rheumatology Researchers of North America, Inc.
    • Principal Investigator: Melanie J. Harrison, MD, MS
    • Co-investigators: Allan Gibofsky, MD, JD, Joseph A. Markenson, MD
    • HSS IRB #: 23017

13. Pilot and Feasibility Study of Modafinil Treatment to Improve Cognitive Efficiency in SLE Patients
    • This study is being conducted in order to determine if the FDA-approved drug Modafinil can improve cognitive function in patients with systemic lupus erythematosus (SLE).
    • Sponsor: Mary Kirkland Center for Lupus Research
    • Principal Investigator: Melanie J. Harrison, MD, MS
    • Co-investigators: Michael D. Lockshin, MD
    • HSS IRB #: 25085