PROFESSIONAL MEMBERSHIPS

Size: px
Start display at page:

Download "PROFESSIONAL MEMBERSHIPS"

Transcription

1

2 June 2012 January 2014 October 2009 May 2012 Staff Rheumatologist, Diagnostic Clinic, Clearwater, FL Staff Rheumatologist, Arthritis Associates, Palm Harbor, FL Co-Investigator, Arthritis Research of Florida, Palm Harbor, FL October 1991 October 2009 Rheumatologist, Private Practice, Palm Harbor & Safety Harbor, FL Investigator, Gulf Coast Pharmaceutical Research, Inc., New Port Richey, FL Co-Investigator, Tampa Bay Medical Research, Inc., Clearwater, FL October 1991 March 2004 December 1987 October 1991 February 1986 December 1987 August 1985 February 1986 January 1983 June 1983 Rheumatologist, Medical Associates of Florida, (Clinic without Walls) Rheumatologist, Mease Clinic, New Port Richey & Safety Harbor, FL Rheumatologist, Private Practice, Bayonet Point & Safety Harbor, FL Employed Position, New Port Richey, FL Internist, ODA Primary Care Satellite Clinic and Kings Brook Hospital Medical Clinic, Brooklyn, NY PROFESSIONAL MEMBERSHIPS American College of Rheumatology American College of Physicians Texas Medical Society RESEARCH ACTIVITIES LECTURES Isolation of IgG RF and Development of an ELISA Assay. Under directorship of Dr. Ed Pisko, Bowman Gray School of Medicine Immunological Research Assistant at Sloan Kettering Institute CME lectures given to Medical Staff of Mease, Bayonet Point and Morton Plant Hospitals Community talks through Mease and Morton Plant Hospitals Community talks through local Arthritis Foundation and Abbott Laboratories

3 ABSTRACTS Goodman, et. Al. A Micromodification of the Sheep Cell Agglutination Test for Rheumatoid Factor: Clinical Usefulness of Combined Testing with the Latex Agglutination Test for the Diagnosis of RA. Clin Res 32:864A, Above abstract presented at the American Federation for Clinical Research. January 31, 1985, New Orleans, LA. BIBLIOGRAPHY Goodman, et. Al. Analysis of Combined Rheumatoid Factor Determinations by the RA Latex and Sheep Cell Agglutination Tests and the ARA Criteria for RA. Journal of Rheumatology. CLINICAL RESEARCH EXPERIENCE 1. Co-Investigator of a One-Year, Open Label Study of the Efficacy, Safety and Tolerance of Pirazolac b.i.d. in Patients with RA. Turner, Goodman, et. al Co-Investigator of the Comparison of Auranofin and Placebo in the Treatment of Psoriatic Arthritis. Wise, Turner,Goodman, et. al Co-Investigator of the Comparison of the Tolerability and Effiacy of the 500 mg b.i.d. Dose of Naproxen, the 1000 mg Controlled Release Formulation of Naproxen Administered Once Daily and 20 mg q.d. of Piroxicam Administered Once Daily in Patients with Active RA. Turner, Goodman, et. al Co-Investigator- Amflutizole vs. Allopurinol for Gout Due to Hyperuricemia. Agudelo, Goodman, et. al Principal Investigator of a Phase 3, Multicenter Study of the safety of Human Anti- TNF Monocolonal Antibody D2E7 in Subjects with active Rheumatoid Arthritis. Protocol Number M Sponsor: Abbott Principal Investigator of a Phase 4 trial of Humira Efficacy Response Optimization in Subjects with Active Rheumatoid Arthritis. Protocol Number M (HERO). Sponsor: Abbott Co-Investigator of a Phase 4, Randomized, Double-Blind, Parallel Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing XXX With XXX and XXX. Protocol number A (PRECISION). Sponsor: Pfizer Co-Investigator of a Phase 3, Randomized, Double Blind, Parallel Group Study of the Mechanism of Action to Evaluate the Effects of il-6 Receptor Blockade with XXX on Lipids, Arterial Stiffness and Markers of Atherogenic Risk in Patients with Moderate to Severe Active Rheumatoid Arthritis. Protocol number WA Sponsor: Hoffmann-La Roche

4 9. Co-Investigator of a Phase 3, Randomized, Double-Blind, Controlled Study of the Long Term Analgesic Efficacy and Safety of XXX Alone or in Combination with Non-steroidal Antiinflammatory Drugs (NSAIDS) vs NSAIDS Alone in Patients with Osteoarthritis of the Knee and Hip. Protocol number: A Sponsor: Pfizer Co-Investigator of a Phase 3, Randomized, Double-Blind, Parallel, International Study to Evaluate the Safety and Efficacy of XXX Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to MTX Therapy. Protocol numbers: ACT4394g1, WA20496 (FEATURE). Sponsor: Genentech Inc Co-Investigator of a Phase 1, Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage Study of the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous XXX in Patients with Rheumatoid Arthritis. Protocol number: CDT4478g. Sponsor: Genentech, Inc Co-Investigator of a Phase 3, Open-Label, Randomized Study to Evaluate Safety, Tolerability and Efficacy of XXX in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDS and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs. Protocol number: ML Sponsor: Hoffman-La Roche Co-Investigator of a Phase 3, 2-year, Randomized, Head to Head, Single Blind Study to Compare the Efficacy and Safety of Subcutaneous XXX vs. XXX, Both with Background MTX, in Biologic Naïve Subjects with Rheumatoid Arthritis. Protocol: (AMPLE) Sponsor: Bristol- Myers Squibb Co-Investigator of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety of XXX for the Prophylaxis of Gout Flares in Patients on Urate Lowering Therapy. Protocol number: IL1TGA0815 (RE-SURGE). Sponsor: Regeneron Pharmaceuticals Principal Investigator of a Phase 3, Randomized, Double-Blind, Parallel Group Study Assessing the Impact of MTX Discontinuation on the Efficacy of Subcutaneous Tocilizumab with MTX Therapy. Protocol number: ML28776 (COMP-ACT) Sponsor: Genentech Inc Current 16. Principal Investigator of a Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csdmards) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bdmards). Protocol number: M Sponsor: AbbVie. January 2016-present 17. Principal Investigator of a Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX. Protocol number: M Sponsor: AbbVie. January 2016-present. 18 Principal Investigator of a Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumabin Subjects with Moderately to Severely Active Rheumatoid Arthritis who are on a Stable Background of Methotrexate (MTX) and who Have an Inadequate

5 Response to MTX (MTX-IR). Protocol number: M14-465: Sponsor: AbbVie. January 2016 present. 19 Principal Investigator of a Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis. Protocol number: M13-545: Sponsor: AbbVie. January 2016 present. 20 Principal Investigator of a Phase 3, Randomized Double -blind, Placebo-and Active-controlled, Multicenter, Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis What Have an Inadequate Response to Methotrexate. Protocol number: GS-US : Sponsor: Gilead. April 2016 present. 21 Principal Investigator of a Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-Rheumatic Drug(s) (csdmards) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment. Protocol number: GS-US : Sponsor: Gilead. April 2016 present. 22 Principal Investigator of a Phase 3, Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy. Protocol number: GS-US : Sponsor: Gilead. April 2016 present.

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 3041-8 Program Step Therapy Medications UnitedHealthcare Pharmacy Clinical Pharmacy Programs *Orencia (abatacept) *This step criteria refers to the subcutaneous formulation of abatacept

More information

Horizon Scanning Technology Summary. Abatacept (Orencia) for juvenile idiopathic arthritis. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Abatacept (Orencia) for juvenile idiopathic arthritis. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Abatacept (Orencia) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time

More information

Horizon Scanning Technology Summary. Adalimumab (Humira) for juvenile idiopathic arthritis. National Horizon Scanning Centre.

Horizon Scanning Technology Summary. Adalimumab (Humira) for juvenile idiopathic arthritis. National Horizon Scanning Centre. Horizon Scanning Technology Summary National Horizon Scanning Centre Adalimumab (Humira) for juvenile idiopathic arthritis June 2007 This technology summary is based on information available at the time

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.18 Subject: Orencia Page: 1 of 6 Last Review Date: December 8, 2017 Orencia Description Orencia (abatacept)

More information

ORENCIA (abatacept) Demonstrates Comparable Efficacy to Humira ( adalimumab

ORENCIA (abatacept) Demonstrates Comparable Efficacy to Humira ( adalimumab ORENCIA (abatacept) Demonstrates Comparable Efficacy to Humira (adalimumab) in Patients with Moderate to Severe Rheumatoid Arthritis in First Head-to-Head Study of These Agents ORENCIA demonstrated comparable

More information

Abatacept (Orencia) for active rheumatoid arthritis. August 2009

Abatacept (Orencia) for active rheumatoid arthritis. August 2009 Abatacept (Orencia) for active rheumatoid arthritis August 2009 This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

1.0 Abstract. Title. Keywords. Adalimumab, Rheumatoid Arthritis, Effectiveness, Safety. Rationale and Background

1.0 Abstract. Title. Keywords. Adalimumab, Rheumatoid Arthritis, Effectiveness, Safety. Rationale and Background 1.0 Abstract Title Assessment of the safety of adalimumab in rheumatoid arthritis (RA) patients showing rapid progression of structural damage of the joints, who have no prior history of treatment with

More information

Atul Kumar Singhal, M.D.

Atul Kumar Singhal, M.D. Atul Kumar Singhal, M.D. Southwest Rheumatology Research LLC 1600 Republic Parkway Suite #200 Mesquite, TX. 75150 asinghal@myarthritisdoc.com Work (972) 288-2600 Fax (972)-288-8886 License Texas State

More information

Overview of Paediatric Investigation Plan (PIP) in Paediatric Rheumatology

Overview of Paediatric Investigation Plan (PIP) in Paediatric Rheumatology Overview of Paediatric Investigation Plan (PIP) in Paediatric Rheumatology Paediatric Rheumatology Expert Meeting, London 4 th December 29 Dr. Richard Veselý, Dr. Emma Sala Soriano Paediatric Investigation

More information

PDF of Trial CTRI Website URL -

PDF of Trial CTRI Website URL - Clinical Trial Details (PDF Generation Date :- Sun, 20 Jan 2019 21:39:27 GMT) CTRI Number CTRI/2009/091/000777 [Registered on: 11/01/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of

More information

Corporate Medical Policy

Corporate Medical Policy Corporate Medical Policy File Name: Origination: Last CAP Review: Next CAP Review: Last Review: abatacept_orencia 4/2008 2/2018 2/2019 2/2018 Description of Procedure or Service Abatacept (Orencia ), a

More information

Orencia (abatacept) DRUG.00040

Orencia (abatacept) DRUG.00040 Market DC Orencia (abatacept) DRUG.00040 Override(s) Prior Authorization Quantity Limit Approval Duration 1 year Medications Comments Quantity Limit Orencia (abatacept) - AGP, VA MCD only 4 vials per 28

More information

CURRICULUM VITAE. Dallas, Texas 75204

CURRICULUM VITAE. Dallas, Texas 75204 CURRICULUM VITAE NAME: BUSINESS ADDRESS: HOME ADDRESS: Rachel Tate, DO Arthritis Care and Research Center Baylor Research Institute 9900 N Central Expressway Dallas, Texas 75231 (214) 373-4321 - Office

More information

Jefferies Healthcare Conference. June 6, 2018

Jefferies Healthcare Conference. June 6, 2018 Jefferies Healthcare Conference June 6, 2018 Forward-Looking Statements and Non-GAAP Financial Information Some statements in this presentation may be forward-looking statements for purposes of the Private

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1)

Regulatory Status FDA-approved indication: Orencia is a selective T cell costimulation modulator indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.18 Subject: Orencia Page: 1 of 8 Last Review Date: March 16, 2018 Orencia Description Orencia (abatacept)

More information

Coverage Criteria: Express Scripts, Inc. monograph dated 12/15/ months or as otherwise noted by indication

Coverage Criteria: Express Scripts, Inc. monograph dated 12/15/ months or as otherwise noted by indication BENEFIT DESCRIPTION AND LIMITATIONS OF COVERAGE ITEM: PRODUCT LINES: COVERED UNDER: DESCRIPTION: CPT/HCPCS Code: Company Supplying: Setting: Kineret (anakinra subcutaneous injection) Commercial HMO/PPO/CDHP

More information

2017 PERIOPERATIVE MEDICINE SYMPOSIUM Peri-operative use of immunosuppression in rheumatology patients

2017 PERIOPERATIVE MEDICINE SYMPOSIUM Peri-operative use of immunosuppression in rheumatology patients 2017 PERIOPERATIVE MEDICINE SYMPOSIUM Peri-operative use of immunosuppression in rheumatology patients Dr Alberta Hoi Rheumatologist MBBS, FRACP, PhD NEW ERA IN MUSCULOSKELETAL MEDICINE New drugs - Biologics,

More information

Charité - University Hospital, Free University and Humboldt University of Berlin, Berlin, Germany; 2 Sanofi Genzyme, Bridgewater, NJ, USA; 3

Charité - University Hospital, Free University and Humboldt University of Berlin, Berlin, Germany; 2 Sanofi Genzyme, Bridgewater, NJ, USA; 3 Efficacy and Safety of Sarilumab Versus Adalimumab in a Phase 3, Randomized, Double-blind, Monotherapy Study in Patients With Active Rheumatoid Arthritis With Intolerance or Inadequate Response to Methotrexate

More information

University of California, San Diego, School of Medicine, La Jolla, CA, USA; 2

University of California, San Diego, School of Medicine, La Jolla, CA, USA; 2 2194 Long-term (104-Week) Efficacy and Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Arthritis: Results From a Phase III, Randomized, Controlled Trial

More information

Horizon Scanning Centre November Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330

Horizon Scanning Centre November Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330 Horizon Scanning Centre November 2012 Secukinumab for active and progressive psoriatic arthritis. SUMMARY NIHR HSC ID: 5330 Secukinumab is a high-affinity fully human monoclonal antibody that antagonises

More information

Orencia (abatacept) for Rheumatoid Arthritis. Media backgrounder

Orencia (abatacept) for Rheumatoid Arthritis. Media backgrounder Orencia (abatacept) for Rheumatoid Arthritis Media backgrounder What is Orencia (abatacept)? Orencia (abatacept) is the first biologic agent to be available in both an intravenous (IV) and a self-injectable,

More information

Technology appraisal guidance Published: 26 January 2016 nice.org.uk/guidance/ta375

Technology appraisal guidance Published: 26 January 2016 nice.org.uk/guidance/ta375 Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed Technology

More information

ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 01/19/2016. ClinicalTrials.gov ID: NCT

ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 01/19/2016. ClinicalTrials.gov ID: NCT ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 01/19/2016 ClinicalTrials.gov ID: NCT00595413 Study Identification Unique Protocol ID: 27905 Brief Title: Atacicept

More information

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES HUMIRA PEDIATRIC

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES HUMIRA PEDIATRIC Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA 24800 HUMIRA PEDIATRIC GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is the patient currently taking Humira? If

More information

CURRICULUM VITAE PATRICK THOMAS SCHUETTE, MD, FACP

CURRICULUM VITAE PATRICK THOMAS SCHUETTE, MD, FACP 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 60053 Bannockburn,

More information

10 Musculoskeletal and Joint Diseases

10 Musculoskeletal and Joint Diseases Recommendations from the Lothian Formulary Committee (FC) following Scottish Medicines Consortium (SMC) advice, NICE MTA advice, (FAF3) unlicensed and off-label medicines and (FAF2) medicines not considered

More information

CURRICULUM VITAE East Riverside Boulevard Rockford, IL 61114

CURRICULUM VITAE East Riverside Boulevard Rockford, IL 61114 CURRICULUM VITAE Name: Present Employer: David J. Dansdill, M.D., F.A.C.R. OrthoIllinois 5875 East Riverside Boulevard Rockford, IL 61114 Date Affiliated: January 2003 Date of Birth: July 25, 1958 Place

More information

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES Generic Brand HICL GCN Exception/Other GOLIMUMAB SIMPONI 22533, 22536, 34697, 35001 ROUTE = SUBCUTANE. GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Is the request for a

More information

NIHR Innovation Observatory Evidence Briefing: November 2017

NIHR Innovation Observatory Evidence Briefing: November 2017 NIHR Innovation Observatory Evidence Briefing: November 2017 Upadacitinib for adults with moderate to severe active rheumatoid arthritis after conventional synthetic disease-modifying anti-rheumatic drugs

More information

(minutes for web publishing)

(minutes for web publishing) Rheumatology Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) Meeting held on 17 October 2017 (minutes for web publishing) Rheumatology Subcommittee minutes are published in

More information

Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC

Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Update on the Treatment of Rheumatoid Arthritis Sabrina Fallavollita MDCM McGill University Canadian Society of Internal Medicine

More information

2017 Blue Cross and Blue Shield of Louisiana

2017 Blue Cross and Blue Shield of Louisiana Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

Certolizumab pegol (Cimzia) for psoriatic arthritis second line

Certolizumab pegol (Cimzia) for psoriatic arthritis second line Certolizumab pegol (Cimzia) for psoriatic arthritis second line This technology summary is based on information available at the time of research and a limited literature search. It is not intended to

More information

Clinical Policy: Tofacitinib (Xeljanz, Xeljanz XR) Reference Number: ERX.SPA.110 Effective Date:

Clinical Policy: Tofacitinib (Xeljanz, Xeljanz XR) Reference Number: ERX.SPA.110 Effective Date: Clinical Policy: Tofacitinib (Xeljanz, Xeljanz XR) Reference Number: ERX.SPA.110 Effective Date: 10.01.16 Last Review Date: 05.18 Revision Log See Important Reminder at the end of this policy for important

More information

Supplementary appendix

Supplementary appendix Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Ruperto N, Martini A. Current and future perspectives

More information

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis New Evidence reports on presentations given at EULAR 2012 Tocilizumab for the Treatment of Rheumatoid Arthritis Report on EULAR 2012 presentations Tocilizumab monotherapy is superior to adalimumab monotherapy

More information

European Medicines Agency decision

European Medicines Agency decision EMA/730065/2010 European Medicines Agency decision P/1/2011 of 3 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP01-08-M03)

More information

Investor Update. Basel, 24 January 2017

Investor Update. Basel, 24 January 2017 Investor Update Basel, 24 January 2017 FDA grants priority review for Roche s Actemra/RoActemra (tocilizumab) supplemental biologics license application for giant cell arteritis, a form of vasculitis Roche

More information

Technology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta195

Technology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta195 Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor Technology appraisal guidance Published: 25 August 2010 nice.org.uk/guidance/ta195

More information

Simponi / Simponi ARIA (golimumab)

Simponi / Simponi ARIA (golimumab) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 6 Last Review Date: September 15, 2016 Simponi / Simponi

More information

CURRICULUM VITAE. RESEARCH SITE NAME/ ADDRESS: Main Office: EDUCATION/TRAINING: BOARD CERTIFIED: BOARD CERTIFIED/ELIGIBLE NAME: TITLE:

CURRICULUM VITAE. RESEARCH SITE NAME/ ADDRESS: Main Office: EDUCATION/TRAINING: BOARD CERTIFIED: BOARD CERTIFIED/ELIGIBLE NAME: TITLE: CURRICULUM VITAE SIGNATURE: NAME: TITLE: Roy C, Springer, MD Principal Investigator DATE: DATE UPDATED: April 2016 RESEARCH SITE NAME/ ADDRESS: Main Office: MD Strategies Research Centers 6280 Jackson

More information

Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs)

Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) Ustekinumab (Stelara) for psoriatic arthritis second line after disease modifying anti rheumatic drugs (DMARDs) January 2010 This technology summary is based on information available at the time of research

More information

1 Executive summary. Background

1 Executive summary. Background 1 Executive summary Background Rheumatoid Arthritis (RA) is the most common inflammatory polyarthropathy in the UK affecting between.5% and 1% of the population. The mainstay of RA treatment interventions

More information

Curriculum Vitae, Joseph J. Savon, M.D.

Curriculum Vitae, Joseph J. Savon, M.D. CONTACT INFORMATION: Joseph J. Savon, M.D. Hassman Research Institute, LLC. 175 Cross Keys Road Centennial Center, Bldg. 300 B Berlin, NJ 08009 Site Selection and Information: Bobbie Theodore, Alliance

More information

Correspondence should be addressed to Martin J. Bergman;

Correspondence should be addressed to Martin J. Bergman; Autoimmune Diseases Volume 2013, Article ID 367190, 7 pages http://dx.doi.org/10.1155/2013/367190 Research Article Composite Indices Using 3 or 4 Components of the Core Data Set Have Similar Predictive

More information

A Clinical Context Report

A Clinical Context Report Rheumatoid Arthritis in Practice An Expert Commentary with Diane Horowitz, MD A Clinical Context Report Rheumatoid Arthritis in Practice Jointly Sponsored by: and Rheumatoid Arthritis in Practice Expert

More information

Technology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373

Technology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373 Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis Technology appraisal guidance Published: 16 December 2015 nice.org.uk/guidance/ta373 NICE 2017. All rights reserved.

More information

CENTER FOR CLINICAL TRIALS St. Luke s Medical Center. Ongoing Clinical Trials DEPARTMENT OF MEDICINE (24)

CENTER FOR CLINICAL TRIALS St. Luke s Medical Center. Ongoing Clinical Trials DEPARTMENT OF MEDICINE (24) CENTER FOR CLINICAL TRIALS St. Luke s Medical Center Ongoing Clinical Trials DEPARTMENT OF MEDICINE (24) Arthritis TITLE : A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis

More information

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of:

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of: Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 8 Last Review Date: March 17, 2017 Simponi / Simponi

More information

Best Practices in Managing Patients with Rheumatoid Arthritis. Summit Medical Group. Standardizing Protocols and Educating Providers

Best Practices in Managing Patients with Rheumatoid Arthritis. Summit Medical Group. Standardizing Protocols and Educating Providers Best Practices in Managing Patients with Rheumatoid Arthritis Summit Medical Group Standardizing Protocols and Educating Providers Organizational Profile Summit Medical Group, established in 1929, is the

More information

More Than Growing Pains: Therapeutic Review of Juvenile Idiopathic Arthritis (JIA)

More Than Growing Pains: Therapeutic Review of Juvenile Idiopathic Arthritis (JIA) More Than Growing Pains: Therapeutic Review of Juvenile Idiopathic Arthritis (JIA) Brittany A. Bruch, PharmD PGY2 Ambulatory Care Pharmacy Resident University of Iowa Hospitals and Clinics November 10,

More information

The use of methotrexate in rheumatological conditions A review of the evidence. Maureen Cox January 2009

The use of methotrexate in rheumatological conditions A review of the evidence. Maureen Cox January 2009 The use of methotrexate in rheumatological conditions A review of the evidence Maureen Cox January 2009 Visser et al Multinational evidence based recommendations for the use of methotrexate in rheumatic

More information

Kevzara (sarilumab) NEW PRODUCT SLIDESHOW

Kevzara (sarilumab) NEW PRODUCT SLIDESHOW Kevzara (sarilumab) NEW PRODUCT SLIDESHOW Introduction Brand name: Kevzara Generic name: Sarilumab Pharmacological class: Interleukin-6 antagonist Strength and Formulation: 150mg/1.14mL, 200mg/1.14mL;

More information

New Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate

New Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate New Evidence reports on presentations given at EULAR 2009 Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate Report on EULAR 2009 presentations Tocilizumab inhibits

More information

TREAT-TO-TARGET IN RHEUMATOID ARTHRITIS

TREAT-TO-TARGET IN RHEUMATOID ARTHRITIS TREAT-TO-TARGET IN RHEUMATOID ARTHRITIS To receive up to 10 CME credits for this activity, complete the evaluation, attestation and post-test answer sheet (minimum passing grade of 70%) and return all

More information

ORENCIA (ABATACEPT) INJECTION FOR INTRAVENOUS INFUSION

ORENCIA (ABATACEPT) INJECTION FOR INTRAVENOUS INFUSION UnitedHealthcare Community Plan Medical Benefit Drug Policy ORENCIA (ABATACEPT) INJECTION FOR INTRAVENOUS INFUSION Policy Number: CS2018D0039J Effective Date: March 1, 2018 Table of Contents Page INSTRUCTIONS

More information

ADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW)

ADALIMUMAB Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) Generic Brand HICL GCN Exception/Other ADALIMUMAB HUMIRA 24800 GUIDELINES FOR USE INITIAL CRITERIA (NOTE: FOR RENEWAL CRITERIA SEE BELOW) 1. Does the patient have a diagnosis of moderate to severe rheumatoid

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Technology appraisals. Patient access scheme submission template

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Technology appraisals. Patient access scheme submission template NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Technology appraisals Patient access scheme submission template October 2009 Patient access scheme submission template October 2009 Page 1 of 24 1

More information

Internal & Hospital Medicine #7001

Internal & Hospital Medicine #7001 Internal & Hospital Medicine #7001 Publications, presentations, and references available upon request. Contact Dora: dmancias@expertwitnessdoctors.com 512-689-6879 EDUCATION 1994 Internal Medicine Residency

More information

September 14, Attached is the original press release made by BMS for your information.

September 14, Attached is the original press release made by BMS for your information. September 14, 2016 European Commission Approves Bristol-Myers Squibb s ORENCIA (abatacept) for the Treatment of Highly Active and Progressive Disease in Adult Patients with Rheumatoid Arthritis Not Previously

More information

Investor Update. Downloads. Services PDF. Basel, 15 May 2018

Investor Update. Downloads. Services PDF. Basel, 15 May 2018 Investor Update Basel, 15 May 2018 FDA approves subcutaneous formulation of Actemra for use in active polyarticular juvenile idiopathic arthritis (pjia), a rare form of juvenile arthritis Roche (SIX: RO,

More information

Recommendations for RA management: what has changed?

Recommendations for RA management: what has changed? The 2016 Update of the EULAR Recommendations for RA management: what has changed? Baltics Rheumatology Conference Vilnius, September 21-22 Prof. Diego Kyburz University Hospital of Basel Switzerland Multiple

More information

The Hospital for Sick Children Technology Assessment at SickKids (TASK)

The Hospital for Sick Children Technology Assessment at SickKids (TASK) The Hospital for Sick Children Technology Assessment at SickKids (TASK) THE USE OF BIOLOGIC RESPONSE MODIFIERS IN POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS Report No. 2010-01 Date: January 11,

More information

Criteria Inclusion criteria Exclusion criteria. despite treatment with csdmards, NSAIDs, and/or previous anti-tnf therapy and/or

Criteria Inclusion criteria Exclusion criteria. despite treatment with csdmards, NSAIDs, and/or previous anti-tnf therapy and/or Supplementary Material Table S1 Eligibility criteria (PICOS) for the SLR Criteria Inclusion criteria Exclusion criteria Population Adults (aged 18 years) with active PsA despite treatment with csdmards,

More information

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis

New Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis New Evidence reports on presentations given at EULAR 2011 Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2011 presentations Benefit of continuing

More information

Rheumatology Cases for the Internist

Rheumatology Cases for the Internist Rheumatology Cases for the Internist Marc C. Hochberg, MD, MPH Professor of Medicine Head, Division of Rheumatology and Clinical Immunology Vice Chair, Department of Medicine University of Maryland School

More information

C. Assess clinical response after the first three months of treatment.

C. Assess clinical response after the first three months of treatment. Government Health Plan (GHP) of Puerto Rico Authorization Criteria Tumor Necrosis Factor Alpha (TNFα) Adalimumab (Humira ) Managed by MCO Section I. Prior Authorization Criteria A. Physician must submit

More information

Curriculum Vitae, Steven H. Reynolds, D.O. Steven H. Reynolds, D.O. Collaborative Neuroscience Network, LLC.

Curriculum Vitae, Steven H. Reynolds, D.O. Steven H. Reynolds, D.O. Collaborative Neuroscience Network, LLC. CONTACT INFORMATION: Site Selection and Information: Bobbie Theodore, Alliance Director Tel. (916) 939-6696 Fax (208) 575-3169 Email: clinicaltrials@alliancesites.com AFFILIATIONS: Collaborative Neuroscience

More information

SYNOPSIS. Clinical Study Report IM Double-blind Period

SYNOPSIS. Clinical Study Report IM Double-blind Period Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier SYNOPSIS (For National Authority

More information

Helpline No:

Helpline No: ARTHRITIS FOUNDATION Registered Nonprofit Organisation - No. 002-847 NPO Helpline No: 0861 30 30 30 DRUGS AND ARTHRITIS This information leaflet is published by the Arthritis Foundation as part of our

More information

Ad-Hoc Rheumatology Subcommittee of PTAC meeting held 8 March. (minutes for web publishing)

Ad-Hoc Rheumatology Subcommittee of PTAC meeting held 8 March. (minutes for web publishing) Ad-Hoc Rheumatology Subcommittee of PTAC meeting held 8 March 2011 (minutes for web publishing) Ad-Hoc Rheumatology Subcommittee minutes are published in accordance with the Terms of Reference for the

More information

ORENCIA (ABATACEPT) INJECTION FOR INTRAVENOUS INFUSION

ORENCIA (ABATACEPT) INJECTION FOR INTRAVENOUS INFUSION ORENCIA (ABATACEPT) INJECTION FOR INTRAVENOUS INFUSION UnitedHealthcare Commercial Medical Benefit Drug Policy Policy Number: 2018D0039J Effective Date: March 1, 2018 Table of Contents Page INSTRUCTIONS

More information

Annual Rheumatology & Therapeutics Review for Organizations & Societies

Annual Rheumatology & Therapeutics Review for Organizations & Societies Annual Rheumatology & Therapeutics Review for Organizations & Societies Comparative Effectiveness Studies of Biologics Learning Objectives Understand the motivation for comparative effectiveness research

More information

ACTEMRA Risk Mitigation Strategy Presenter Name, Degree

ACTEMRA Risk Mitigation Strategy Presenter Name, Degree ACTEMRA Risk Mitigation Strategy Presenter Name, Degree Medical Science Liaison Genentech, Inc. 1 Indications and Dosage Rheumatoid Arthritis (RA) (1 of 2) Indication in RA ACTEMRA (tocilizumab) is indicated

More information

(tofacitinib) are met.

(tofacitinib) are met. Xeljanz (tofacitinib) Policy Number: 5.01. 560 Origination: 3/2014 Last Review: 3/2014 Next Review: 3/2015 Policy BCBSKC will provide coverage for Xeljanz (tofacitinib) when it is determined to be medically

More information

Krystexxa (pegloticase) Document Number: IC-0158

Krystexxa (pegloticase) Document Number: IC-0158 Krystexxa (pegloticase) Document Number: IC-0158 Last Review Date: 06/27/2017 Date of Origin: 02/07/20103 Dates Reviewed: 11/2013, 08/2014, 07/2015, 07/2016, 09/2016, 12/2016, 03/2017, 06/2017 I. Length

More information

Pharmacy Medical Necessity Guidelines: Actemra (tocilizumab)

Pharmacy Medical Necessity Guidelines: Actemra (tocilizumab) Pharmacy Medical Necessity Guidelines: Effective: July 11, 2017 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review SQ: RXUM/ RX / Pharmacy (RX) or Medical

More information

Regulatory Status FDA-approved indication: Orencia is a selective T cell co-stimulation modulator indicated for: (1)

Regulatory Status FDA-approved indication: Orencia is a selective T cell co-stimulation modulator indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Orencia Page: 1 of 9 Last Review Date: September 20, 2018 Orencia Description Orencia (abatacept)

More information

Initial Phase 3 Studies Results for Rilonacept in the Prevention of Gout Flares in Patients Initiating Uric Acid-lowering Therapy and the Treatment

Initial Phase 3 Studies Results for Rilonacept in the Prevention of Gout Flares in Patients Initiating Uric Acid-lowering Therapy and the Treatment Initial Phase 3 Studies Results for Rilonacept in the Prevention of Gout Flares in Patients Initiating Uric Acid-lowering Therapy and the Treatment of Patients in the Midst of an Acute Gout Attack Investor

More information

Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis

Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis New Evidence reports on presentations given at EULAR 2010 Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2010 presentations

More information

WARNING: RISK OF SERIOUS INFECTIONS

WARNING: RISK OF SERIOUS INFECTIONS RA PROGRESSION INTERRUPTED 1 DOSAGE AND ADMINISTRATION GUIDE No structural damage progression was observed at week 52 in 55.6% and in 47.8% of patients receiving KEVZARA 200 mg + MTX or 150 mg + MTX, compared

More information

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3)

Regulatory Status FDA- approved indication: Simponi and Simponi ARIA are tumor necrosis factor (TNF) blockers indicated for the treatment of: (2-3) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.51 Subject: Simponi / Simponi ARIA Page: 1 of 9 Last Review Date: March 16, 2018 Simponi / Simponi

More information

Jefferies Healthcare Conference June 8, 2017

Jefferies Healthcare Conference June 8, 2017 Jefferies Healthcare Conference June 8, 2017 1 Forward-Looking Statements and Non-GAAP Financial Information Some statements in this presentation may be forward-looking statements for purposes of the Private

More information

certolizumab pegol (Cimzia )

certolizumab pegol (Cimzia ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided

More information

ACTEMRA (tocilizumab)

ACTEMRA (tocilizumab) ACTEMRA (tocilizumab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs

More information

Drug Class Review Targeted Immune Modulators

Drug Class Review Targeted Immune Modulators Drug Class Review Targeted Immune Modulators Final Update 5 Report June 2016 The purpose of reports is to make available information regarding the comparative clinical effectiveness and harms of different

More information

Perioperative Medicine:

Perioperative Medicine: Perioperative Medicine: Management of rheumatologic agents Divya Gollapudi, MD May 2016 Medical Operative Consult Clinic Harborview Medical Center Your patient Ms. L is a 55 year-old F w/ h/o RA who presents

More information

Regulatory Status FDA approved indication: Kineret is an interleukin-1 receptor antagonist indicated for: (1)

Regulatory Status FDA approved indication: Kineret is an interleukin-1 receptor antagonist indicated for: (1) Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.50 Subject: Kineret Page: 1 of 5 Last Review Date: March 17, 2017 Kineret Description Kineret (anakinra)

More information

Synopsis (C0743T10) CNTO 1275 Module 5.3 C0743T10. Associated with Module 5.3 of the Dossier

Synopsis (C0743T10) CNTO 1275 Module 5.3 C0743T10. Associated with Module 5.3 of the Dossier Module 5.3 Protocol: EudraCT No.: 2005-003525-92 Title of the study: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered

More information

TRANSPARENCY COMMITTEE OPINION. 26 April 2006

TRANSPARENCY COMMITTEE OPINION. 26 April 2006 TRANSPARENCY COMMITTEE OPINION 26 April 2006 REMICADE 100 mg powder for concentrate for solution for infusion Box of 1 (CIP code: 562 070.1) Applicant : laboratoires Schering Plough List I Drug for hospital

More information

apremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd.

apremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd. apremilast 10mg, 20mg, 30mg tablets (Otezla ) SMC No. (1053/15) Celgene Ltd. 08 May 2015 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards

More information

ACTEMRA (TOCILIZUMAB) INJECTION FOR INTRAVENOUS INFUSION

ACTEMRA (TOCILIZUMAB) INJECTION FOR INTRAVENOUS INFUSION ACTEMRA (TOCILIZUMAB) INJECTION FOR INTRAVENOUS INFUSION UnitedHealthcare Commercial Medical Benefit Drug Policy Policy Number: 2018D0043I Effective Date: March 1, 2018 Table of Contents Page INSTRUCTIONS

More information

ACTEMRA (TOCILIZUMAB) INJECTION FOR INTRAVENOUS INFUSION

ACTEMRA (TOCILIZUMAB) INJECTION FOR INTRAVENOUS INFUSION ACTEMRA (TOCILIZUMAB) INJECTION FOR INTRAVENOUS INFUSION UnitedHealthcare Oxford Clinical Policy Policy Number: PHARMACY 284.9 T2 Effective Date: June 1, 2018 Table of Contents Page INSTRUCTIONS FOR USE...

More information

For Rheumatoid Arthritis

For Rheumatoid Arthritis For Rheumatoid Arthritis APRIL 2017 NOTICE: On April 14, 2017 the FDA issued a complete response letter for baricitinib indicating that the FDA is unable to approve the application in its current form

More information

Understanding Rheumatoid Arthritis

Understanding Rheumatoid Arthritis Understanding Rheumatoid Arthritis Understanding Rheumatoid Arthritis What Is Rheumatoid Arthritis? 1,2 Rheumatoid arthritis (RA) is a chronic autoimmune disease. It causes joints to swell and can result

More information

Clinical Policy: Tocilizumab (Actemra) Reference Number: ERX.SPMN.44

Clinical Policy: Tocilizumab (Actemra) Reference Number: ERX.SPMN.44 Clinical Policy: (Actemra) Reference Number: ERX.SPMN.44 Effective Date: 10/16 Last Review Date: 09/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory

More information

PRODUCT INFORMATION HUMIRA

PRODUCT INFORMATION HUMIRA NAME OF THE MEDICINE Adalimumab (rch) DESCRIPTION PRODUCT INFORMATION HUMIRA (adalimumab) is a recombinant human immunoglobulin (IgG1) monoclonal antibody containing only human peptide sequences. was created

More information