CURRICULUM VITAE PATRICK THOMAS SCHUETTE, MD, FACP

Transcription

1 CURRICULUM VITAE PATRICK THOMAS SCHUETTE, MD, FACP Illinois Bone and Joint Institute, LLC, Office Locations: 9000 Waukegan Road 2101 Waukegan Road Suite 200 Suite 110 Morton Grove, IL Bannockburn, IL Phone: (847) Phone: (847) Fax: (847) Fax: (847) PROFESSIONAL EXPERIENCE 1/01-Present Rheumatologist, Illinois Bone & Joint Institute, LLC, Morton Grove, IL Practice clinical rheumatology; teach medical students and residents from affiliated hospitals. Specialist in osteoporosis, back pain, epidural steroid injection, rheumatoid arthritis, ultrasound Present 1981-Present Director, Division of Rheumatology, Advocate Lutheran General Hospital, Park Ridge, IL Assistant Professor Clinical Medicine, Northwestern University Medical School, Chicago, IL Co-Director Osteoporosis Center, Advocate Medical Group, Park Ridge, IL /01 Rheumatologist Lutheran General Medical Group/Advocate Medical Group, Niles, IL Rheumatologist Private Practice, Chicago, IL Chief of Rheumatology Ravenswood Hospital, Chicago, IL Weiss Hospital, Chicago, IL Grant Hospital, Chicago, IL Columbus Hospital, Chicago, IL EDUCATION B.A., History, Yale University, New Haven, CT M.D., Medical University of South Carolina, Charleston, SC POSTGRADUATE MEDICAL TRAINING 1/74 6/74 Internship (Neurology) Medical University of South Carolina, Charleston, SC Residency (Internal Medicine) University of Illinois, Chicago, IL Fellowship (Rheumatology) Northwestern University Medical School, Chicago, IL Updated 7/22/2016 1

2 FACULTY APPOINTMENTS Instructor of Clinical Medicine Feinberg School of Medicine, Northwestern University, Chicago, IL 1981-Present 2003-Present Assistant Professor of Clinical Medicine Feinberg School of Medicine, Northwestern University, Chicago, IL Instructor of Clinical Medicine Finch School of Health Sciences, The Chicago Medical School, No. Chicago, IL MEDICAL LICENSURE 1973-Present Illinois Medical License and DEA Registration HOSPITAL APPOINTMENTS 1977-Present Consulting Member Medical Staff Northwestern Memorial Hospital, Chicago, IL Director of Rheumatology Attending Medical Staff Ravenswood Hospital, Chicago, IL 1989-Present Attending Medical Staff Advocate Lutheran General Hospital, Park Ridge, IL Advocate Illinois Masonic Hospital, Chicago, IL Holy Family Hospital, Des Plaines, IL 2003-Present Northshore Systems, Evanston, IL BOARD CERTIFICATIONS 1997 Certified Illinois Society for Clinical Densitometry Re-Certified 2001 and Subspecialty Board of Rheumatology, Participating in Maintenance of Certification 1977 American Board of Internal Medicine 1975 National Board of Examiners PROFESSIONAL ASSOCIATIONS Fellow - American College of Physicians Fellow - American College of Rheumatology Chicago Rheumatism Society International Society of Clinical Densitometry American Institute of Ultrasound Medicine International Society for Extremity MRI in Rheumatology 2011-Present Clinical Congress of Rheumatology Planning Committee, Destin, Florida PUBLICATIONS Kar, P, Aronoff, G, Schuette, P: Bronchopulmonary Disease: An Association With Ulcerative Colitis and Pyoderma Gangrenosum KMA Journal, Vol 91: , Hughes S, Edelman P, Chang R, Naughton R, Singer R, Schuette PT, Liang G: Validity of self-reported prevalence of musculoskeletal conditions in the elderly American Journal of Public Health. Hughes S, Edelman P, Chang R, Naughton R, Singer R, Schuette PT, Liang G, Estimates and determinants of valid self-reports of musculoskeletal disease in the elderly. Journal of Aging and Health, Vol 5, No , Updated 7/22/2016 2

3 Hughes S, Edelman P, Chang R, Singer R, Schuette PT: Their GERI-AIMS scales for the elderly. Reliability and Validity. Arthritis and Rheumatism, 34: 856,1991. Hughes S, Edelman P, Chang R, Singer R, Schuette PT. The revised arthritis impact measurement scales for the elderly: new validity and reliability finding. Arthritis and Rheumatism, (Supplement). 31 (4): S76, Hughes S, Chang R, Edelman P, Blandford G, Berg L, Singer R, Schuette PT. Use and measurement properties of the revised arthritis impact measurement scales for the elderly. Arthritis and Rheumatism, (Supplement). 30: S101,1987. Hughes S, Chang R, Blandford G, Berg L, Edelman P, Singer R, Schuette PT. Musculoskeletal disease in the elderly: prevalence and associated functional impairment. Arthritis and Rheumatism, (Supplement). 29: 147, Schuette, PT: The recurrent joint pain questionnaire. Presented at International Symposium on the Epidemiology of Rheumatic Diseases in Industrial Labor. Hamburg, West Germany, June Arnold W, Stulberg SD, Schuette PT, Schmidt FR. Intraarticular soft tissue abnormalities are a frequent finding associated with chronic pain. Patients with early Osteoarthritis of the knee. Arthritis and Rheumatism, (Supplement). 27, Wells JS, Zipp FJ, Schuette PT, MeElency J. Musculoskeletal disorders among letter carriers. A comparison of weight carrying, walking and secondary occupations. Journal of Occupational Medicine, 25 (11): 814, Green D, Schuette PT, Wallace WH: Factor VIII antibodies in rheumatoid arthritis: The effect of antibodies in rheumatoid arthritis: the effect of cyclophosphamide. Archives of Internal Medicine, 140: 1232,1980. Schuette PT, Schmid FR. Arthritic syndromes associated with enteropathies. Clinical Medicine, Harper and Row Publishers, Schuette PT, Brabham AM, Eurenious K. Thrombotic thrombocytopenia purpura: A re-evaluation. Southern Medical Journal, 67: 915, RESEARCH STUDIES PRINCIPAL CLINICAL INVESTIGATOR Smith & Nephew, Inc., Orthopaedic Division, Memphis, TN A Non-significant Risk Investigational Device Exemption Clinical Study to Evaluate the Safety and Effectiveness of the Resonance Platform in Treating Post-Menopausal Osteopenic Women. May 03, 2002 Principal Clinical Investigator o Planned Study o Designed protocol to clinical aspects of study o Set control group, inclusion/exclusion criteria and clinical end points o Testified before FDA panel PRIMARY INVESTIGATOR A : A randomized, double-blind, placebo-controlled phase 2 study to 2011 Ongoing assess the immune response following administration of influenza and pneumococcal vaccines to subjects with rheumatoid arthritis receiving CP- 690,550 or placebo CP-690,550 with and without background methotrexate. Updated 7/22/2016 3

4 2009 Ongoing Merrimack Merrimack Ongoing Merrimack Pharmaceuticals, Inc. Inc Merrimack Pharmaceuticals, Inc Amgen Amgen A : A phase 3 randomized, double-blind, placebo-controlled study of the efficacy and safety of 2 doses of CP-690,550 in patients with active rheumatoid arthritis on background methotrexate. MM OLE2: An open-label, multi-center, long-term extension study to assess the safety, tolerability, and efficacy of MM-093 treatment in subjects with rheumatoid arthritis who completed participation in protocol MM MM : A phase 2, double-blind, placebo-controlled study to evaluate the efficacy and safety of 60 mg of MM-093 versus placebo in patients with active rheumatoid arthritis on stable doses of methotrexate. A : A long-term, open-label follow-up study of Tasocitinib (CP- 690,550) for treatment of rheumatoid arthritis. A : A phase 2b, randomized, double-blind, placebo-controlled activecomparator, multi-center study to compare 5 dose regimens of CP-690,550 and Adalimumab versus placebo, administered for 6 months in the treatment of subjects with active rheumatoid arthritis. MM OLE: An open-label, multi-center, long-term extension study to assess the safety, tolerability and effect on disease status of MM-093 treatment in subjects with rheumatoid arthritis who completed prior studies of MM-093. A : A randomized, double-blind, placebo- and positive-controlled, parallel group, multi-center study of oral doses of CJ-023,423 administered for 4 weeks to subjects with osteoarthritic pain of the knee. MM : A phase 2, double-blind, parallel, placebo-controlled, randomized study to evaluate the efficacy and safety of 3 different dose levels (2.5, 7.5 and 20 mg) of MM-093 in patients with active rheumatoid arthritis on stable doses of methotrexate : Rheumatoid arthritis DMARD intervention and utilization study (RADIUS 2) : Rheumatoid arthritis DMARD intervention and utilization study. CO-INVESTIGATOR Crescendo Bioscience 2012 Ongoing 2011 Ongoing 2011 Ongoing 999RA002: Biomarkers of Anti-TNF-α Therapy Efficiency in Rheumatoid Arthritis to Define Unresponsive Patients. CAIN457F2309: A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long-term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-tnfa agents. H9B-MC-BCDP: A phase 3b, multicenter, open-label study to evaluate the long-term safety and efficacy of LY in patients with rheumatoid arthritis (RA). Updated 7/22/2016 4

5 Stryker Biotech 2011 Ongoing 2010 Ongoing Roche 2010 Ongoing Stryker Biotech Roche 2009 Ongoing Horizon Therapeutics Roche UCB Genentech Anika Therapeutics, Inc. 10-OA-004: An open-label, safety extension study of repeat dosing with intraarticular bone morphogenetic protein (BMP-7) in subjects with osteoarthritis (OA) of the knee. H9B-MC-BCDO: A phase 3, multi-center, randomized, double-blind, placebocontrolled study to evaluate the safety and efficacy of LY in patients with rheumatoid arthritis (RA) with or without background disease-modifying anti-rheumatic drug (DMARD) therapy. WA22762: A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. 09-OA-002: A phase 2, double-blind, randomized, placebo-controlled, proof of concept, dose-finding study of intra-articular bone morphogenetic protein (BMP-7) in subjects with osteoarthritis (OA) of the knee. WA19926: A multi-center, randomized, double-blind, parallel group study of the safety, remission and prevention of structural joint damage during treatment with Tocilizumab (CZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe early rheumatoid arthritis (RA). HZ-CA-401: Open-label safety study of HZT-501 in patients who require longterm daily non-steroidal anti-inflammatory drug treatment. A : A phase 3, multi-center, randomized, long-term study of the safety of Tanezumab in patients with osteoarthritis of the knee or hip. F1J-MC-HMGP: Duloxetine 60 mg once daily versus placebo in the treatment of patients with osteoarthritis knee pain. ML 22533/B: 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 anti-rheumatic drugs (DMARDs) in patients with active rheumatoid arthritis who have an inadequate response to current non-biologic or biologic DMARDs. C87084: A phase 3b, multi-center open-label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with methotrexate in patients with active rheumatoid arthritis who participated in C A : A phase 3 randomized, double-blind placebo and Naproxencontrolled multi-center study of the analgesic efficacy and safety of Tanezumab in patients with osteoarthritis of the knee. ACT 4562g: A phase 2, randomized, double-blind, parallel group study to evaluate the efficacy and safety of ocrelizumab in combination with methotrexate compared with Infliximab plus methotrexate in patients with active rheumatoid arthritis currently responding inadequately to Etanercept or Adalimumab. Monovisc-0802: A study of the safety of repeat injection of intra-articular Updated 7/22/2016 5

6 MONOVISC sodium hyaluronate in patients with osteoarthritis of the knee. Anika Therapeutics, Inc. Monovisc-0702: A randomized, double-blind, placebo-controlled, multi-center study of a single injection cross-linked sodium hyaluronate (HA) to provide symptomatic relief of osteoarthritis of the knee. Pozen, Inc UCB Smith & Nephew Genentech Seikagaku , Inc Genentech Amgen Johnson & Johnson Seikagaku Corp PN : A randomized, double-blind, parallel group, placebo-controlled multi-center study evaluating the efficacy of PN 400 BID and Celecoxib 200 mg QD in patients with osteoarthritis of the knee. A : A 2-year randomized, double-blind, parallel group, placebocontrolled study to investigate the safety and efficacy of orally administered SD-6010 in subjects with symptomatic osteoarthritis (OA) of the knee. C87077: Evaluation of the safety and efficacy of an Certolizumab Pegoladministered concomitantly with a stable-dose methotrexate in patients with active rheumatoid arthritis (RA). SU-SHO-0106: A multi-center, randomized, double-blind, placebo controlled trial of three injections of SUPARTZ (sodium hyaluronate) for the treatment of chronic shoulder pain associated with glenohumeral osteoarthritis. WA20495/ACT3986g: A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-tnf therapy. GEL/1132: A multi-center, extension and open-label study of a single or repeat intra-articular injection of Gel-200 in osteoarthritis of the knee. A : A 2-week, randomized, double-blind, placebo- and positivecontrolled, parallel group, multi-center study of CE-224, 535 in subjects with osteoarthritic pain of the knee. WA20494/ACT3985g: A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment : An open-label study to assess the safety and immunogenicity of etanercept serum-free process when administered to subjects diagnosed with rheumatoid arthritis. CZOL446H2409: A one-year partial double-blinded, randomized, multi-center, multi-national study to assess the effects of combination therapy of annual zoledronic acid (5mg) and daily subcutaneous teriparatide (20 mcg) on postmenopausal women with severe osteoporosis. F1J-MD-HMEP: Duloxetine 60 to 120 mg versus placebo in the treatment of patients with osteoarthritis knee pain. C : A phase 2a multi-center, randomized, double-blind, placebocontrolled, parallel group study of RWJ cathepsin-s inhibitor in patients with active rheumatoid arthritis despite methotrexate therapy. SKK-6606: A multi-center, randomized, double-blind, controlled, parallel group study of a single intra-articular injection of Gel-200 with a single intra-articular Updated 7/22/2016 6

7 Hoffmann-La Roche, Inc. Hoffmann-La Roche, Inc Ongoing Inc. Inc Inc Hoffmann-La Roche, Inc Abbott Laboratories Pharmaceuticals Corp Genzyme Corporation, Biosurgery Roche Laboratories, Inc Amgen injection of phosphate-buffered saline (PBS) in osteoarthritis of the knee. B3D-MC-GHCY: The effect of teriparatide compared with risedronate on back pain in postmenopausal women with osteoporotic vertebral fractures. PA 18604: A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA). WA 18696: A long-term extension study of safety during treatment with tocilzumab (MRA) in patients completing treatment in MRA core studies. A : A six-week, double-blind, randomized, multi-center comparison study of the analgesic effectiveness of Celecoxib 200 mg BID compared to tramadol hydrochloride 50 mg QID in subjects with chronic low back pain. A : A 12-week, open-label, safety trial of Pregabalin in patients with fibromyalgia. A : A 13-week, randomized, double-blind, placebo-controlled trial of Pregabalin twice daily in patients with fibromyalgia. WA17824: A randomized, double-blind, double-dummy, parallel group study determining the effect of MRA as a monotherapy by comparing it with a regimen of methotrexate (MTX) alone, in patients with active rheumatoid arthritis who have not been treated with MTX within 6 months of randomization. M : Humira efficacy response optimization study in subjects with active rheumatoid arthritis (HERO). CCOX189A2367: A 13-week, multi-center, randomized, double-blind, doubledummy, placebo-controlled, parallel group trial of lumiracoxib (COX189) 100 mg o.d. in patients with primary hip osteoarthritis using celecoxib (200 mg o.d.) as a positive control. SYNV : A multi-center, parallel, double-blind, masked-observer, randomized comparison of the efficacy and safety of Synvisc (hylan G-F 20) and Depo-Medrol (methylprednisolone acetate) in patients with mild to moderate primary osteoarthritis of the hip. ML 18057: A prospective, open-label, multi-center study to evaluate the change in bone turnover markers after once monthly oral ibandronate therapy treatment in naïve postmenopausal osteoporosis patients. CCOX 189A2369: A 52-week, international, multi-center, randomized, doubleblind, double-dummy, parallel group clinical trial to compare retention on treatment, safety, tolerability and efficacy of lumiracoxib 100mg od, lumiracoxib 100mg bid and celecoxib 200mg od in patients with primary osteoarthritis of hip, knee, hand or spine. H4Z-MC-GJAE: Effects of arzoxifene on bone mineral density and endometrial histology in postmenopausal women : A phase 4, open-label, single-arm, observational study evaluating the effectiveness and safety of enbrel (etanercept) 50 mg once weekly in Updated 7/22/2016 7

8 Merck & Company, Inc TAP Merck & Company, Inc Merck Merck & Company, Inc. Merck Merck & Company, Inc Merck & Company, Inc Abbott rheumatoid arthritis subjects who have failed remicade (infliximab). MK : A 26-week, randomized, placebo- and active-comparatorcontrolled, parallel group, double-blind, two-part study to assess the safety and efficacy of etoricoxib 30 mg versus celecoxib 200 mg in patients with osteoarthritis (Study 1). B3D-US-GHCQ: FORTEO observational study. C02-021: A phase 3, open-label study, randomized, allopurinol-controlled study to assess the long-term safety of oral febuxostat in subjects with gout. CZOL446H2310: A multi-national, multi-center, double-blind, randomized, placebo-controlled, parallel group study assessing the efficacy of intravenous zoledronic acid in preventing subsequent osteoporotic fractures after a hip fracture. MK : A randomized, double-blind, multi-center study to evaluate the tolerability and effectiveness of etoricoxib 90 mg Q.D. versus diclofenac sodium 75 mg B.I.D. in patients with rheumatoid arthritis. A : A double-blind, placebo-controlled study of the efficacy and tolerability of once daily celebrex (celecoxib) vs. placebo in the treatment of subjects with osteoarthritis of the knee non-responsive to naproxen and ibuprofen. MK : A 12-month extension to: a randomized, double-blind, double-dummy, parallel group, multi-center study to evaluate and compare the effects of once weekly alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis (FOSAMAX ACTONEL Comparison Trial - FACT). MK : A randomized, double-blind, multi-center study to evaluate the tolerability and effectiveness of etoricoxib 90 mg Q.D. vs. diclofenac sodium 50 mg T.I.D. in patients with osteoarthritis (OA). MK : A randomized, double-blind, multi-center, placebocontrolled study to compare the safety and tolerability of an oral buffered solution of alendronate sodium 70 mg once weekly versus placebo for the treatment of osteoporosis in postmenopausal women. MK : A randomized, placebo-controlled, parallel group, doubleblind, study to evaluate the safety and efficacy of rofecoxib 12.5 mg and celecoxib 200 mg in patients with osteoarthritis of the knee. A : A study to evaluate biochemical markers associated with osteoarthritis (OA) disease activity in OA patients compared to age and gender matched controls. MK : A randomized, double-blind, active-comparator-controlled, parallel group study to evaluate the safety of etoricoxib in patients with osteoarthritis or rheumatoid arthritis. M02-498: A multi-center study of the safety of human anti-tnf monoclonal antibody adalimumab (D2E7) in subjects with active rheumatoid arthritis. Updated 7/22/2016 8

9 Aventis Merck Aventis TAP Fujisawa Lilly Aventis HMR 4003F/4001: A one-year, multi-center, randomized, double-blind, placebo-controlled, parallel group study to determine the efficacy and safety of 35-mg risedronate administered once a week in the prevention of osteoporosis in postmenopausal women. MK : A randomized, double-blind, double-dummy, parallel group, multi-center study to evaluate and compare the effects of once weekly alendronate and risedronate on bone mineral density in postmenopausal women with osteoporosis. HMR 4003B/4027: A randomized, multi-center, parallel group study to determine if knowledge of baseline vertebral fracture prevalence (as determined by hologic IVA) and bone turnover marker levels improves persistence with actonel 5 mg daily therapy in subjects receiving chronic glucocorticoid therapy. C02-009: A phase 3, randomized, multi-center allopurinol and placebocontrolled study assessing the safety and efficacy of oral febuxostat in subjects with gout : A randomized, double-blind study to assess the efficacy of tacrolimus (prograf) + methotrexate vs. placebo + methotrexate in the treatment of rheumatoid arthritis in patients with partial response to methotrexate. H3S-US-GGKO: Raloxifene alendronate comparison in postmenopausal women with low bone mass. A : Postmenopausal evaluation and risk-reduction with lasofoxifene. A : A double-blind, placebo-controlled, dose-ranging trial to evaluate the efficacy of atorvastatin on bone mineral density and markers for bone turnover in postmenopausal women with dyslipidemia and at risk for osteoporosis. HMR 4003E/3002: A multi-center, randomized, active-controlled, single-blind, parallel group comparison of risedronate 5mg flexible-dosing instructions to before-breakfast dosing instructions in postmenopausal women with osteoporosis. Updated 7/22/2016 9