Arthritisassociatesinc.com

Board Certified Rheumatology / Internal Medicine
BOARD CERTIFIED RHEUMATOLOGY & INTERNAL MEDICINE The North Shore Center for
Arthritis Treatment and Clinical Research
ARTHRITIS ASSOCIATES, INC.
MATTHEW D. HELLER, MD, FACR
PRACTICE LIMITED TO THE DIAGNOSIS & TREATMENT OF ARTHRITIS & RELATED MUSCULOSKELETAL DISORDERS PERSONAL DATA
Married: 2 Children. Residence: Boxford, MA Columbia University; Graduated BA New York, New York Tufts University School of Medicine, Graduated Medical Doctor Boston, MA University of Chicago Hospitals and Clinics, Medical Intern, Tufts New England Medical Center, Medical Resident, Major, US army Medical Corps, Danang, Republic of South Vietnam Research Fellow in Medicine, Arthritis Unit, Massachusetts General Hospital, Boston, MA Certified; American Board of Internal Medicine; #43014 Certified; Diplomat in Subspecialty of Rheumatology Private Practice specializing in Musculoskeletal disorders Arthritis Associates Inc.
PROFESSIONAL MEMBERSHIPS
New England Rheumatism Association
Founding Fellow of American College of Rheumatology
Massachusetts Medical Society
Massachusetts Society of Internal Medicine
American College of Physicians

PUBLICATIONS
New England Journal of Medicine; 280:693-703, 1969
“Soroff et al: Physiological Support of Heart Action”
Harvard Medical School Continuing Education Program
Movie and cassette tape: Arthrocentesis
Federal Tri State Program
“RMP Pilot Project Proposal for the design of Health Care Delivery System in Arthritis”
Submitted 3/74: Approved, not funded
Frank O’Dell, Publisher
“Joint Venture, Arthritis, Something can be Done.”
Boston North,: December, 1982, January, 1983 public information article on arthritis.
JAMA, April, 1983, Vol. 249:#14
“Hand Difficulties Amongst Musicians”
Multi-investigator study on Benoxaprofen versus Clinoril in the treatment of osteoarthritis.
Hochberg, Leffert and Heller
Excerpta Medica
“Treatment of Rheumatoid Arthritis, Transfer Treatment of
Injectable Gold to Oral Gold”
Menger, G.C. Burnhard, M.D., Heller, M.D., W.O. O’Brien
Proceeds of the Smith, Kline & French Symposium; Auranofin; 1983.
Clinical Pharmacology Therapy 1985, Feb: 37 (2) 186 Abstract III-D
“Sucralfate Therapy on Nonsteroidal anti-inflammatory Drug Induced (NSAID) Gastritis”.
Caldwell, HR; Roth, SH: Heller, MD; March, WH; Wu, WC; Sembler, EL
Gastroenterology 1985, May, 88; (5 PT 2): 1636 (Abstract
“Sucralfate (SCR) Therapy of Nonsteroidal Anti-Inflammatory Drug-Induced
Gastritis”,
Wu, WC; Sembler, ER; Castello, DO; Caldwell, JR; Roth, SH; Heller, MD; Marsh, WH
Arthritis and Rheumatism: 1985, April 28 (supl. 4) S 52 Abstract A 53
“Sucralfate Therapy in Nonsteroidal Anti-Inflammatory Drug-Induced Arthritis”
Caldwell, HR; Roth, SH; Marsh, WH: Heller, MD: Wu, WC; Semple, EL;
American Journal of Medicine; Vol. 83; (3B) September 28, 1982: page 74.
“Sucralfate Treatment of Nonsteroidal Anti-Inflammatory Drug Induced Gastrointestinal
Symptoms of Mucosal Damage”
Caldwell; Roth: Wu; Semble, Castello, Heller and Marsh
Internal Medicine World Report Vol. 15 No. 8 July 2000 page 7
“Case of the Month” Musculoskeletal Pain in an Older Patient
“Where Do We Go From Here? A Review of NSAIDs and the Risk of Serious Coronary Heart
Disease”. Distributed by Genecom.
“Where Do We Go From Here? A Review of NSAIDs and the Risk of Serious Coronary Heart Disease”. Clinician’s Perspective, Issue 2. “COX-2 Inhibitors in Coronary Health, A Review of the NUT-2 Pilot Study” by Ofman, et. Al., copyright Genecom, 2003. “COX-2 Inhibitors in Coronary Health, A Review of the NUT-2 Pilot Study” by Ofman, et. al., Clinician’s Perspective, Issue #4. “Meloxicam and Platelet Function, A Critique: Render et. al.”, Journal of Clinical Pharm., 2002, Vol. 22, pages 881-86. Copyright Genecom, 2003. “Is There Golf After Arthritis? How to Reduce Your Handicap”. Published in Arthritis Today, 2003. “Why Educated Patients are Better Patients”. Arthritis Today, 2003. “Step Care Approach to Osteoarthritis Pharmacotherapy”. Supplement Drug Benefit Trends (DBT). Singh, Heller, Silver, Singleton, Toomey, Triadalopoulos. “Step Care Approach to Osteoarthritis Pharmacotherapy”. Supplement to Consultant, May, 2003, Vol. 43 No. 6. “Step Care Approach to Osteoarthritis Pharmacotherapy”. Supplement DBT. . “Step Care Approach to Osteoarthritis Pharmacotherapy”. Proceedings of a Round Table. Journal of Musculoskeletal Medicine, June, 2003 supplement. Singh, Heller, Silver, Singleton, Toomey, Triadalopoulos. TEXTBOOK Clinical Research Opportunities, 164 pages, Matthew D. Heller M.D. and Tony Boyle M.D Book Publisher: P.M.I.C., Los Angeles, CA, May, 1996. Selected by Doody’s Rating Service as one of the 250 Best Health Sciences Books, 1997.
PRINCIPAL INVESTIGATOR FOR THE FOLLOWING
CLINICAL RESEARCH TRIALS:

Sandoz, 1977-1976
Double blind study of Proquazone vs. salicylates in osteoarthritis
Wyeth Company, 1977
Double blind study of Oxaprozin vs. salicylates in rheumatoid arthritis
Robins Company 1977-1978
Phase 2-dose titration study on ARH 5850; rheumatoid arthritis
Eli Lilly, 1978
• Double-blind study of Benoxaprofen vs.Motrin in osteoarthritis
• Double-blind study on Flurbiprofen vs. salicylates
Upjohn Company, 1978 Double-blind study of ARH 5850 vs. salicylates in rheumatoid arthritis Smith, Kline & French, 1978 Phase II study of Auranofin in rheumatoid arthritis Merck, Sharp & Dohme, 1978-1979 Double-blind study of Diflunisal in osteoarthritis *Diflunisal, now marketed as DOLOBID® was approved by the FDA in 1988 Merck, Sharp & Dohme, 1980 Double-blind study of Diflunisal in rheumatoid arthritis *Diflunisal, now marketed as DOLOBID® was approved by the FDA in 1988 Merck, Sharpe and Dohme, 1980 Phase II study of Indocin GTs in rheumatoid arthritis Merck, Sharpe and Dohme, 1980 Phase III study of Indocin SR in osteoarthritis Eli Lilly, Co., 1980 Phase III study of Benoxaprofen vs. Naprosyn in osteoarthritis Smith, Kline and French, 1980 Phase III study of Auranofin vs. intramuscular gold Ciba Geigy, 1980 Phase IV study of Voltaren vs. aspirin in rheumatoid arthritis Eli Lilly Co., 1980 Naprosyn vs. Benoxaprofen as a possible remission inducing drug in rheumatoid arthritis Smith Kline & French, 1983 Chronic Auranofin treatment in rheumatoid arthritis • Motrin vs. ASA/Tylenol in osteoarthritis • ASA vs. placebo vs. Indoprofen in osteoarthritis Boots, 1983 Diflunisal vs. Feldene in rheumatoid arthritis Berlex, 1983 Pirazolac open label in osteoarthritis Hoechst Marion Roussel, 1984 Double-blind study of Carafate vs. placebo in the treatment of gastric mucosal damage with symptoms associated wit the use of nonsteroidal anti-inflammatory drugs Upjohn 1984 Double-blind study: Arbacet vs. placebo in the treatment of aspirin or nonsteroidal anti-inflammatory drug-induced gastric lesions Eli Lilly Co., 1984 Triple-blind comparison of Fenoprofen calcium, enteric coated with Fenoprofen calcium non-enteric-coated in osteoarthritis Upjohn, 1984 Double-blind study; sustained release Flurbiprofen formation vs. standard Flurbiprofen in osteoarthritis Ayerst Laboratory, 1984 Double-blind study of Ultradol vs. Piroxicam in degenerative joint disease of the knee Menley and James Laboratory, 1985 Comparative study of the efficacy and safety of Ecotrin vs. Ibuprofen in treatment of pain an other symptoms of osteoarthritis Syntex Laboratory; 1985 Double blind randomized parallel long-term comparison of Naproxen 750 mg with Naproxen 1500-mg in-patients with rheumatoid arthritis Ciba-Geigy, 1984 Open label study of Voltaren® Treatment of patients with rheumatoid arthritis vs. open label study of marketed nonsteroidal drug treatment in-patients with rheumatoid arthritis Syntex Laboratory, 1985 Comparison of controlled-release Naprosyn, 1000 mg and Naprosyn 500 mg b.i.d. in the treatment of patients with osteoarthritis Marion Laboratory, 1986 The effect of Sucralfate given in conjunction with Piroxicam or Naprosyn; Effect on gastrointestinal upset and blood loss Upjohn Company, 1987 A comparison of NSAID-SR tablets with NSAID tablets in the treatment of patients with osteoarthritis of the knee Syntex Laboratory, 1987 A comparison of the safety and efficacy of Naproxen 500 mg b.i.d. standard formulation with Naproxen 500-mg b.i.d. low level excipient in-patients with osteoarthritis Upjohn, 1987 A comparison of Motrin sustained release tablets, 800 mg and Motrin 600 mg in the treatment of rheumatoid arthritis Upjohn Company, 1988 A comparison of ANSAID-SR tablets with ANSAID tablets in the treatment of patients with osteoarthritis of the hip Ciba-Geigy Pharmaceutical Company, 1988 Double blind comparative study of Prinomide vs. Naprosyn vs. placebo in vs. arthritis: Pfizer, Inc., 1989-1990 • Multi-center double blind placebo controlled, fixed dose, dose response study of a sodium salt formulation in patients with osteoarthritis • Multicenter double-blind, placebo controlled, fixed dose response study (sodium salt formulation) in patients with rheumatoid arthritis Syntex, 1990 Phase II double-blind study of RS 61433 in rheumatoid arthritis Proctor & Gamble; Miami Valley Laboratories, 1991 Phase II double-blind study of Tebufelone in osteoarthritis of the knee Smith, Kline Beecham, 1991 Phase III open label randomized trial comparing Nabumetone to Voltaren in patients with rheumatoid or osteoarthritis Wyeth Ayerst, 1991 Double blind parallel comparison of safety and efficacy of arthritis Syntex, 1992-1993 • Nine-month double blind multiple dose efficacy and safety comparison of Mycophenolate Mofetil 2 grams daily versus 4 grams daily in Rheumatoid arthritis patients • Placebo controlled randomized double-blind withdrawal of Mycophenolate Mofetil followed by a 52-week open label extension stud inn rheumatoid arthritis patients • A 3-month double-blind, parallel safety and efficacy evaluation of oral ketorolac MR 20 mg b.i.d. Naproxen 500 mg b.i.d. and placebo in the treatment of symptomatic osteoarthritis of the hip and knee Synergy 1992 An open label multi-center extension trial of Human Recombinant Interluekin-1 Receptor antagonist in patients with active rheumatoid arthritis Synergen 1993 A dose ranging study of Human Recombinant Interluekin-1 Receptor Antagonist in patients with active rheumatoid arthritis and arthritic flares Proctor and Gamble 1993-1999 • Randomized double-blind placebo controlled parallel study for safety and efficacy of *Risedronate in the treatment of osteoporosis, monitoring the incidence of hip and vertebral fractures in elderly women • Randomized double-blind placebo controlled multi-center, parallel group study to determine the efficacy and safety of *Risedronate in the prevention of corticosteroid-induced osteoporosis *Risedronate, now marketed as ACTONEL™, was approved by the FDA in 1998 Syntex 1994 Placebo controlled comparison of Aleve and Extra-Strength Tylenol for minor pain associated wit arthritis of the hip and knee Hoechst Marion Roussel, Inc. 1995-1998 Double-blind randomized placebo controlled study to compare the activity and safety of *Leflunomide to Methotrexate or placebo in-patients with active rheumatoid disease *Leflunomide, now marketed as ARAVA®, was approved by the FDA in 1999 Smith, Kline Beecham, 1997 Evaluation of protective efficacy, safety and immunogenicity of a recombinant DNA expressed protein vaccine for Lyme subjects for Lyme disease Merck, 1997-1998 *Alendronate Triple-blinded randomized active controlled parallel group multi-center study to evaluate and compare the efficacy and tolerability of Alendronate sodium with calcium supplementation in the treatment of osteoporosis in the community dwelling ambulatory postmenopausal women *Alendronate, now marketed as FOSAMAX ® , was approved by the FDA in 1997 Hoffman LaRoche 1997-1998 • Double blind randomized parallel group with multicenter comparison of S.C.S. TNF55 to reference treatment with oral Methotrexate and their combination in-patients with rheumatoid arthritis • Double-blind randomized placebo controlled study to evaluate safety and efficacy of RO 32-3555 as adjunct to background anti-rheumatoid therapy in preventing structural joint damage in rheumatoid arthritis Hoffman LaRoche 1997-1998 • A double-blind, double-dummy, randomized parallel group, multicenter comparison of the efficacy and safety of mycophenolate mofetil (MMF-RS 61443) po (1g bid) and Neoral (oral cyclosporin microemulsion solution) in patients with active rheumatoid arthritis (6 month efficacy study) who are candidates for immunosuppressive therapy of rheumatoid arthritis. Rollover Extension: A double-blind, double-dummy, randomized, parallel group, multicentre comparison of the efficacy and safety of mycophenolate mofetil (MMF- RS 61443) po (1 g bid) and Neoral (oral cyclosporin microemulsion solution) in patients with active rheumatoid arthritis (6–month efficacy study) who are candidates for immunosuppressive therapy of rheumatoid arthritis. Hoffmann-LaRoche AG WA15938 1999-2000 Joint Development and Diagnostics Sample Repository Project. For use in conjunction with rheumatoid arthritis patients who participated in previous studies Merck & Co. 1997-1999 • Active comparator controlled parallel group double blind to assess the safety and efficacy of *MK 0966 vs. diclofenac in patients with osteoarthritis of the knee or hip • Double-blind randomized parallel-group 52 week study to assess safety and efficacy of a novel therapeutic agent *MK-0966 in patients with rheumatoid arthritis • A two part, double-blind, randomized, multicenter, parallel group, 52 week study to assess the safety and tolerability, and to further define the clinically effective dose range of *MK-0966 in patients with rheumatoid arthritis. • Phase IV, randomized, placebo controlled, parallel group, double blind study to evaluate the efficacy and safety of MK-0966 12.5 mg vs. nabumetone 1000-mg in-patients with osteoarthritis of the knee. *MK-0966, now marketed as VIOXX ®, was approved by the FDA in 1999 Snow Brand Products 1998 Phase III Double-blind randomized placebo controlled study of SNI-2011 vs. placebo in-patients with Sjogren’s syndrome. Hoffman La Roche, 1997-2003 Phase II • A double-blind randomized, placebo controlled study to evaluate the safety and efficacy of Ro 32-3555, as adjunct to background anti-rheumatoid therapy, in preventing structural joint damage in patients with rheumatoid arthritis. Hoffman La Roche, 1997-1998 Phase II A double blind, randomized, 6 arm, parallel-group, dose finding, double-dummy, multi-center comparison of anti TNF/Lenercept subcutaneous to reference treatment with oral Methotrexate and their combinations in patients with rheumatoid arthritis Endo Pharmaceuticals Inc., 1999-2000 Phase II Double blind, placebo controlled, parallel group, dose ranging comparison of the efficacy and safety of controlled release oxymorphone (Numorphan CR) controlled release Oxycodone (Oxycontin) and placebo in the treatment of osteoarthritis of the knee and or hip. G.D. Searle & Co. 1999-2000 Phase III/ GERD trial. Clinical protocol for a multicenter, double blind, placebo-controlled, parallel group study comparing the incidence of gastroduodenal ulcer associated with valdecoxib 10 mg and 20 mg qd, with that of ibuprofen 800 mg tid and diclofenac sodium 75 mg bid, taken for 12 weeks in patients with osteoarthritis. G. D. Searle Research and Development 1999-2000 Phase IIIb Revised clinical protocol for a multicenter, double-blind, parallel group study comparing the incidence of clinically significant upper gastrointestinal adverse events associated with *SC-58635 400 mg bid, to that of Diclofenac 75 mg bid, in patients with osteoarthritis or rheumatoid arthritis *SC-58635, now marketed as CELEBREX® , was approved by the FDA in 1999 Anika Therapeutics Inc., 1999-2000 Phase III Device Study A study of the safety and efficacy of intra-articular ORTHOVISC® sodium Hyaluronate injections in providing symptomatic relief of osteoarthritis of the knee. Boehringer Ingelheim Pharmaceuticals, 1999-2000 Phase IIIb Open label study to compare prescription non-steroidal anti-inflammatory drug changes, healthcare utilization, efficacy and safety of Meloxicam/COX II in patients with osteoarthritis of the hand, knee, hip or spine. Meloxicam, now marketed as MOBIC ®, was approved by the FDA in April 2000 Immunex Corporation, 2001 – 2002 Phase III Double-blinded, randomized, placebo-controlled study of Enbrel (etanercept) in the treatment of rheumatoid arthritis subjects with comorbid disorders. Almiral, 2001-2002 Phase II Randomized, double blinded, placebo-controlled, parallel-group, multicenter, clinical trial to evaluate the safety and efficacy of three doses LAS 34475 vs. placebo and Naproxen 500 mg in patients with osteoarthritis of the knee. Immunex Corporation, 2001 – 2002 Phase III Intervention and Utilization Study (RADIUS I) Impath – BCP, 2001-2002 Phase III The Discovery and Evaluation of Biomarkers for the Prediction, Diagnosis and Management of Autoimmune Disorders. Merck, 2002 – 2003 Phase III 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. Merck & Co., Inc., 2004 – 2005 Protocol 077-00/COX 553 A 26-week, randomized, placebo- and active-comparator-controlled, parallel-group, double-blind, 2-part study to assess the safety and efficacy of etoricoxib 30 mg vs. celecoxib 200 mg in patients with osteoarthritis. Endo Pharmaceuticals, Inc., 2004-2005 Protocol EN3260-001 A randomized, double-blind, pilot study comparing the efficacy and safety of Lidocaine 5% patch with placebo in patients with pain from osteoarthritis of the knee. Novartis Consumer Health, Inc., 2005 – 2006 Protocol VOSG-PE-315 An 8-week, multi-center, randomized, double-blind, placebo-controlled, parallel group trial of diclofenac sodium gel 1% in patients with primary osteoarthritis of the hand. Bristol-Myers Squibb Pharmaceutical Research Institute, 2005 – 2007 Protocol IM101064 A Phase III, multi-center, open label study to evaluate the efficacy, tolerability and safety of Abatacept (BMS-188667) in subjects with active rheumatoid arthritis on background non-biologic DMARDs who have an inadequate response to anti-TNF therapy and have limited therapeutic options. Primus Pharmaceuticals, Inc., 2007 Protocol LOA-03P A double blind, randomized, placebo controlled, parallel group, multi-center study of flavocoxid (LimbrelTM) vs. naproxen in subjects with moderate-severe osteoarthritis of the knee. CombinatoRx, Inc., 2007 – present Protocol CRx-102-006 A randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy of CRx102 in subjects with symptomatic knee osteoarthritis. Pfizer, Inc., 2008-present Protocol A4091011 A Phase 3 randomized, double-blind, placebo-controlled multi-center study of the analgesic efficacy and safety of Tanezumab in patients with osteoarthritis of the knee. Pfizer, Inc. 2009-present Protocol A4091016 A Phase 3 randomized, double-blind, placebo-controlled multi-center study of the analgesic efficacy and safety of Tanezumab in patients with osteoarthritis of the knee Roche Laboratories, Inc. 2009-present Protocol ML225331A 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
STAFF APPOINTMENTS / CONSULTING APPOINTMENTS
Northeast Health System, Beverly, MA
Tufts University School of Medicine Senior Clinical Instructor in Medicine, Academic Year 1985-1986 Guest of Food and Drug Administration Arthritis Advisory Committee, 1976 Neuropractice, Editorial Board Raven Publishers, Haggerstown, Professional Golf Association of America Consultant on Disability appointed July 1, 2004
TELEVISION / LECTURE APPEARANCES

Massachusetts Medical Society – Lecture, October 2002
“Medical Problems of Musicians”
Consultant and Speakers Bureau for:
Merck, Pfizer, Amgen, Boehringer Ingelheim, Proctor and Gamble, Wyeth, and Lilly
Pharmaceutical Companies
Boehringer Ingelheim Pharmaceuticals, 9/02 – 10/02, Facilitator to Teleconference
Balancing the safety and efficacy of the treatment of osteoarthritis
Boehringer Ingelheim Pharmaceuticals: Arthritis Huddle events with Joe Namath
www arthritis huddle.com
WCVB TV NewsCenter 5- Healthbeat, Sept. 25, 1998
“New Drugs Attack Cause of Arthritis”.
Salem Access Television, August 1998
“A Discussion with Dr. Heller”
Half-hour program describing the latest breakthroughs in arthritis research.
Filmed at Beverly Hospital in Beverly, MA. Salem, MA Airing on SATV Salem, MA 2 times a
week from August 1998 to present
“Nightline” NBC TV
Guest Appearance, August, 1982
“Good Morning New York” ABC TV
Guest Appearance 1982
Warner Cable TV, Malden, MA, September 1977
“Arthritis, Something Can Be Done.”
Wrote and directed one-hour program on Arthritis
“Public Information Show” June, 1982, WJAR, Providence, RI
Appearance with Jim Mendes
NewsCenter 5- Healthbeat, October 24, 1996
“New Arthritis Medication”
Participated in AWARE for ALL Clinical Research Education and Awareness Day
Sponsored by the Center for Information and Study in Clinical Research Participation
Northeastern University, May 21, 2005; June 4, 2006
2005 AWARE for ALL Distinguished Speaker Award
Center for Information and Study on Clinical Research Participation
2006 AWARE for ALL Distinguished Speaker Award
2nd Annual Clinical Research Education and Awareness Day
Center for Information and Study on Clinical Research Participation

SPECIAL INTERESTS
Clinical Research
“Is There Golf After Arthritis: How to Reduce Your Handicap”
Musculoskeletal Problems of Musicians

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