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OP0135 (2021) : SAFETY AND EFFICACY OF SUBCUTANEOUS BELIMUMAB AND INTRAVENOUS RITUXIMAB COMBINATION IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME: A PHASE 2, RANDOMISED, PLACEBO-CONTROLLED 68-WEEK STUDY

Researchers

Presenter

  • X. Mariette

Principal Investigators

  • C. Baldini

  • F. Barone

  • H. Bootsma

  • K. Clark

  • S. De Vita

  • K. Lerang

  • P. Mistry

  • F. Morin

  • R. Punwaney

  • R. Seror

  • P. L. Van Daele

  • N. Wisniacki

  • D. Roth

Medical Centers

  • Université Paris- Saclay, Rheumatology, Paris, France

  • Rheumatology Unit, Department of Clinical and Experimental Medicine, University of Padua, Padua, Italy

  • University of Birmingham, College of Medical and Dental Sciences, Rheumatology, Birmingham, United Kingdom

  • University of Groningen, University Medical Center Groningen, Department of Medical Oncology, Groningen, Netherlands

  • GlaxoSmithKline, Clinical Science, London, United Kingdom

  • Azienda Ospedaliera Universitaria di Udine, Rheumatology Clinic, Department of Medical Area, Udine, Italy

  • Oslo University Hospital, Department of Pathology, Oslo, Norway

  • GlaxoSmithKline, R&D Biostatistics, Stevenage, United Kingdom

  • Centre de Recherche Musculo-Squelettique, Centre de Recherche Musculo-Squelettique, Trois Rivieres, Canada

  • GlaxoSmithKline, Pharmaceutical Research and Development, Philadelphia, PA, United States of America

  • Erasmus Medical Center, Department of Internal Medicine and Department of Immunology, Rotterdam, Netherlands

  • GlaxoSmithKline, Clinical Pharmacology and Experimental Medicine, Stevenage, United Kingdom

  • GlaxoSmithKline, Discovery Medicine, Stevenage, United Kingdom

  • GlaxoSmithKline, Global Medical Affairs, Collegeville, PA, United States of America

Locations

  • France

  • Italy

  • United Kingdom

  • Netherlands

  • Norway

  • Canada

  • United States

Companies

  • N/A

Study Components

Therapeutic Area

  • Autoimmune (AI)

Disease

  • Sjogren's syndrome

Biomarkers

  • Cytokeratin 20

Drug/Treatment

  • Belimumab

  • Rituximab

Outcome

  • N/A

Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Controlled

Phase

  • II

Study Id's

  • NCT02631538

Sponsors

  • GlaxoSmithKline (GSK)

Result

  • N/A

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