Marika Kvarnström

Consultant (Senior Physician) at Academic Specialist Center, Center for Rheumatology and Studieenheten, Stockholm Health Services, Region Stockholm, Sweden

Education:

1994: Medicine Doctor (M.D) Umeå University, Umeå

1996: Licensed Physician

2002: Licensed Specialist in Internal Medicine

2005: Licensed Specialist in Rheumatology

2014: PhD, Karolinska Institutet

Conducted clinical trials as PI from 2015

Principal Investigator for 12 clinical trials

10 sponsored studies and 2 academic studies.

National Coordinating Investigator for 8 sponsored studies

Co-Investigator for 30 studies from 2018 to present

List see below

Clinical Trials

Rheumatology

Autoimmunity

Sjögren´s Disease

Principal Investigator in the following Clinical Trials:

• 1.     UCB SS0004: Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome, EudraCT number 2014-004523-51, at the Rheumatology Clinic´s Research unite, Karolinska University Hospital, sponsor UCB, National Coordinating Investigator Marika Kvarnström, IMP: UCB5857, duration 2015-2017
• 2.     Medimmune: A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome, EudraCT number is missing, at the Rheumatology Clinics´ Research unite, Karolinska University Hospital, sponsor Medimmune, National Coordinating Investigator Marika Kvarnström, IMP: AMG 557/MEDI5872, duration 2016-2018.
• 3.     BMS IM101603: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjogren’s Syndrome, EudraCT number 2016-001948-19, at the Rheumatology Clinics´ Research unite, Karolinska University Hospital, sponsor BMS, National Coordinating Investigator Marika Kvarnström, IMP abatacept, duration 2017-2020.
• 4.     GSK 201842: Phase 3,  A randomized, double blind (sponsor open), comparative, multi-center study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab co-administration in subjects with primary Sjögren’s syndrome, EudraCT number: 2015-00400-26, at Karolinska Trial Alliance, Karolinska University Hospital, sponsor GSK,  IMP belilumab och rituximab,  duration 2016-2018.
• 5.     TWINSS. Phase 2. Clinical Trial Protocol CCFZ533B2201. A 48-week, 6-arm, randomized, double-blind, placebo controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS). EudraCT number: 2018-004476-35, at Academic Specialist Center, Center for Rheumatology, Stockholm Health Services, Region Stockholm, sponsor Novartis, National Coordinating Investigator Marika Kvarnström, IMP iscalimab, duration 2021-2022.
• 6.     TWINSS-ES. Phase 2b. Clinical Trial Protocol CCFZ533B2201E1, A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome, EudraCT number: 2020-001942-20, at Academic Specialist Center, Center for Rheumatology, Stockholm Health Services, Region Stockholm, sponsor Novartis, National Coordinating Investigator Marika Kvarnström, IMP iscalimab, duration 2022-2023.
• 7.     NECESSITY, Phase 3, New Clinical End-points in patients with primary Sjögren’s Syndrome: an Interventional Trial based on stratifying patients, EudraCT No: 2019-002470-32, at Academic Specialist Center, Center for Rheumatology, Stockholm Health Services, Region Stockholm, sponsor AP-HP, National Coordinating Investigator Marika Kvarnström, IMPs: Hydroxychloroquine, Leflunomide and mycophenolate mofetil, duration 2022-2026 (ongoing).
• 8.     NEPTUNUS-2, Phase 3, Clinical Trial Protocol CVAY736A2302, A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjögren’s syndrome, EudraCT number: 2021-005687-22, at Academic Specialist Center, Center for Rheumatology, Stockholm Health Services, Region Stockholm, sponsor Novartis, National Coordinating Investigator Marika Kvarnström, IMP ianalumab, duration 2022-(ongoing).
• 9.     BHV3000-404, Phase 4, A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention with Multiple Dosing Regimens, EudraCT number: 2021-005239-22, at Academic Specialist Center, Studieenheten, Stockholm Health Services, Region Stockholm, sponsor: Biohaven Pharmaceuticals Holding Company Limited, National Coordinating Investigator Marika Kvarnström, IMP: BHV-3000 (rimegepant), duration 2023-2024.
• 10.  BRONCHIOLE. Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE), Phase 4, (randomized 1:1 in a non-blinded fashion, to either usual care and intervention with a beta-1-antagonist), EudraCT no: 2017-001507-76, at Academic Specialist Center, Studieenheten, Stockholm Health Services, Region Stockholm, sponsor: Örebro University, School of Medical Sciences, Department of Cardiology, Örebro, IMP: metoprolol, duration 2023-2024.
• 11.  NEPTUNUS-2-ES Phase 3, Clinical Trial Protocol CVAY736A2301E1, A randomized, double-blind, 2-arm NEPTUNUS extension study to assess the long-term safety and efficacy of ianalumab in patients with Sjögren’s syndrome, EudraCT number: 2022-502966-26, at Academic Specialist Center, Center for Rheumatology, Stockholm Health Services, Region Stockholm, sponsor Novartis, National Coordinating Investigator Marika Kvarnström, IMP ianalumab, duration 2024-(ongoing).
• 12.  LIPIGON, A phase 2 randomised, double-blind, placebo-controlled trial to evaluate safety and local tolerability of four weekly administrations of A24110He in subjects with type 2 diabetes mellitus and elevated triglyceride plasma concentrations, EudraCT number: 2023-509091-42-00, at Academic Specialist Center, Studieenheten, Stockholm Health Services, Region Stockholm, sponsor: Lipigon Pharmaceuticals AB, IMP: A24110He, duration: 2024-(ongoing).

1989-1991: Teaching Assistant 20% 1 Jan 1989 to 31 May 1989, 1 Aug 1989 to 31 May 1990 and 1 Aug 1990 to 31 May 1991 at the Department of Histology and Cell Biology, Umeå University Umeå, Sweden

2008-2009: Teaching Assistant 30% 1 Sep 2008 to 30 May 2009 at the Rheumatology Clinic, Karolinska University Hospital.

2021-2023: Teaching Assistant at CFR – responsible for medical students