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THU0570 (2018) : Long-term efficacy and safety of canakinumab in patients with colchicine-resistant fmf (CRFMF, traps and hids/mkd: results from the pivotal phase 3 cluster trial

Researchers

Presenter

  • F. De Benedetti

Principal Investigators

  • J. Frenkel

  • A. Simon

  • J. Anton

  • H. Lachmann

  • M. Gattorno

  • S. Ozen

  • I. Kone-Paut

  • E. Ben-Chetrit

  • M.B. Wozniak

  • J.G. Wang

  • E. Vritzali

Medical Centers

  • IRCCS Ospedale Bambino Gesu, Roma, Italy

  • University Medical Center Utrecht,

  • Radboud University Medical Center, Njmegen, Netherlands

  • Hospital Sant Joan de Deu de Barcelona, Barcelona, Spain

  • Division of Medicine, National Amyloidosis Center, University College London Medical School, London, UK

  • Pediatry, G. Gaslini Institute, Genova, Italy

  • Hacettepe University Children's Hospital, Ankara, Turkey

  • Hopital Kremlin Bicetre, University of Paris SUD, Paris, France

  • Hadassah-Hebrew-University-Medical-Cente, Jerusalem, Israel

  • Novartis Ireland Ltd., Dublin, Ireland

  • Novartis AG, Basel, Switzerland

Locations

  • Italy

  • Netherlands

  • Spain

  • United Kingdom

  • Turkey

  • France

  • Israel

  • Ireland

  • Switzerland

Companies

  • N/A

Study Components

Therapeutic Area

  • Obstetrics/Gynecology

  • Genetic Disorder

Disease

  • Hyperimmunoglobulinemia D and periodic fever syndrome

Biomarkers

  • N/A

Drug/Treatment

  • canakinumab (SC)

  • Colchicine

  • Epoch

Outcome

  • N/A

Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Open Label

  • Controlled

Phase

  • III

Study Id's

  • NCT02059291

Sponsors

  • Novartis

Result

  • N/A

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