Katy M. Setoodeh MD KATY M. SETOODEH, M.D., F.A.C.R. Curriculum Vitae Personal: Address: 8737 Beverly Blvd, Suite 302 Los Angeles, CA 90048 Phone: (310) 652-0920 E mail: drkatysetoodeh@gmail.com Education: BS Neuroscience (Cum Laude)—University of California Los Angeles, 1997 MD, University of California, Los Angeles, 2002 Internal Medicine Internship University of California, Irvine, 2002-2003 Research Fellowship, 2002-2003 Internal Medicine Residency, UCLA-Olive View Medical Center, 2004-2006 Rheumatology Fellowship, University of Southern California, 2006-2008 Certifications and Licensures: American Board of Internal Medicine, August 2006 American Board of Internal Medicine, Rheumatology Subspecialty, October 2008 Hospital Privileges: Cedars Sinai Medical Center Clinical Research Affiliations: Primary Investigator: Wallace Rheumatic Studies Center 8737 Beverly Blvd., Suite 301 Los Angeles, CA 90048, July 2011 Sub Investigator: Wallace Rheumatic Studies Center 8737 Beverly Blvd., Suite 301 Los Angeles, CA 90048, October 2009 Sub Investigator: Cedars Sinai Medical Center, October 2009 Memberships in Professional Societies: American College of Physicians Southern California Rheumatology Society American College of Rheumatology, Fellow Honorary Appointments: Fellow, American College of Rheumatology (FACR) Member, American Society of Clinical Rheumatologists Publications: 1. Charmas H, Barra D, Elstner E, Setoodeh K, Koeffler HP, Heber D, Preadipocytes stimulate breast cancer cell growth, Nutrition and Cancer 1998; 32: 59-63 Book Chapters: 1. Setoodeh K, Wallace D, Who develops Sjogren’s? , in The New Sjogren’s Syndrome Handbook, Oxford University Press, Inc., New York, NY, in press 2. Setoodeh K, Nonsteroidal anti-inflammatory drugs for the treatment of Lupus, in Dubois’ Lupus Erythematosus, Lippincott Williams & Wilkins, Philadelphia, PA, in press Clinical Research Involvement: 1. A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE). Sponsored by Human Genome Sciences. 2. A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 in the United States. Sponsored by Human Genome Sciences 3. A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B Antibody (Monoclonal Anti-Blys Antibody) in Subjects with Systemic Lupus Erythematosus (SLE) Who Completed the Phase 2 Protocol LBSL02. Sponsored by Human Genome Sciences. 4. A Phase IIb, Multi-center, Open-label, Follow-up Study to Assess the Safety and Efficacy of Epratuzumab in Serologically positive Systemic Lupus Erythematosus Patients with Active Disease who Participated in Study SLOOO7. Sponsored by UCB, Inc. 5. An Open Label Re-treatment trial for Patients Previously Randomized into the SLOOO3 and SLOOO4, Randomized, Double-blind, Placebo controlled, multi-center Studies of Epratuzumab in Patients with Systemic Lupus Erythematosus. SLOOO6 Sponsored by UCB, Inc. 6. A randomized, double-blind, placebo-controlled, single dose-escalation and multiple dose extension trial of NNC 0152-0000-0001 administered i.v. or s.c. in subjects with Systemic Lupus Erythematosus. Sponsored by Novo Nordisk 7. Placebo-controlled study to evaluate efficacy and safety of certolizumab pegol in subjects wit- A phase 3, multicenter, randomized, double-blind, pl h active axial spondyloarthritis (AS001). 2010 – Sponsored by UCB 8. Duke Autoimmunity Pregnancy Registrsy (DAP Regristry), 2010- 9. Studies of B cell abnormalities in Systemic Lupus Erythematosus via MiRNA. 2010 – 10. Concurrrent pilot studies in Giant cell arteritis and Takayasu’s arteritis to examine the safety, efficacy, and immunologic effects of abatacept (CTLA4-Ig) in large vessel vasculitis. 2010 – 11. IM 101-167, A Phase IIIb, Multicenter, Randomized, Withdrawal study to evaluate the Immunogenicity and safety of Subcutaneously Administered Abatacept in Adults with Active Rheumatoid Arthritis, 2008-. Sponsored by BMS 12. 797-201, A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study To Investigate The Safety, Efficacy, Pharmacokinetics and Pharmacodynamics Of 12 Weeks Of Treatment With ARRY-371797 In Patients With Active Ankylosing Spondylitis And Inadequate Response To Conventional Therapy. 2009-2009 Sponsored by Array BioPharm Inc 13. A Phase IIIB, multi-centre study with a 12 week double-blind, placebo-controlled, randomized period, followed by an open-label extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. 2008-2010 Sponsored by UCB 14. ML22533/A, An open-label, randomized study to evaluate the safety, tolerability and efficacy of tocilizumab (TCZ) monotherapy or TCZ in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in patients with active rheumatoid arthritis who have an inadequate response to current non-biologic or biologic DMARDs. 2009 – Sponsored by Roche Laboratories Inc 15. SLICC, Lymphoma Risk in SLE: A Consequence of Immune Suppression or Stimulation? 2009- 16. Lupus Clinical Trials Consortium, Inc., LCTC Lupus Data Registry. 2009- 17. Cedars Sinai Medical Center, Cross Cultural Spanish Validation of Lupus Pro: A Patient Reported Outcome Measure for Lupus. 2009- 18. A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients with Active Lupus Arthritis. PROTOCOL LA-LAQ-202. 2010 - , NCT01085084 Sponsored by TEVA Pharm 19. A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus. 2010- Sponsored by CEPHALON 20. Denosumab Study 20101218- Prospective Observational Study to Evaluate Persistence Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis in Routine Clinical Practice. Sponsored by Amgen Abstracts: 1. Weng H, Ranganath VK, Park GS, Setoodeh KM, Khanna D, Clements PJ, Furst D, Initial presentation of systemic scleroderma in the young and elderly are the same except for their age related changes, Arthritis Rheum 52:, 2005 2. Weng H, Ranganath VK, Park GS, Khanna D, Clements PJ, Setoodeh K, Furst D, Differences in presentation of young and older systemic scleroderma patients in SSc trials, Arthritis Rheum 2006; 53: abstract 1858. 3. Setoodeh KM, Arkfeld DG, Minocycline for the treatment of skin changes in scleroderma, Ann Rheum Dis 2008; 67 (supp 2): 622 4. Arkfeld DG, Setoodeh KM, Abrahim J, Cole SE, Metyas S, The inability of most US patients to tolerate the recommended doses of pregabalin in the treatment of fibromyalgia, Ann Rheum Dis 2008; 67 (supp 2): 261. 5. Arkfeld DG, Setoodeh KM, Abrahim J, Cole SE, Metyas S, The inability of most US patients to tolerate the recommended doses of pregabalin in the treatment of fibromyalgia, Arthritis Rheum 2008; 58: abst 723. Organizations and Positions Held: Member, UC Irvine College of Medicine Student Advisory Board 1998-2000 Member, Medical Advisory Board of Lupus LA 2010