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THU0503 : PLUTO TRIAL: SENSITIVITY ANALYSES OF SRI4 RESPONSE WITH BELIMUMAB VS PLACEBO IN PAEDIATRIC PATIENTS WITH CHILDHOOD-ONSET SYSTEMIC LUPUS ERYTHEMATOSUS (CSLE)

Researchers

Presenter

  • N. Ruperto

Principal Investigators

  • H. Brunner

  • M. Mori

  • J. Clinch

  • R. Syed

  • N. Iwata

  • D. Bass

  • B. Ji

  • A. Hammer

  • M. Okily

  • G. Eriksson

  • H. Quasny

Medical Centers

  • Istituto Giannina Gaslini, Genoa, Italy

  • Perinatal Institute, Cincinnati Children’s Hospital, Cincinnati, United States of America

  • Tokyo Medical and Dental University, Tokyo, Japan

  • University of Bristol, Bristol, United Kingdom

  • St Louis University, St Louis, United States of America

  • Aichi Childrens Health and Medical Center, Obu, Aichi, Japan

  • GlaxoSmithKline plc, Collegeville, United States of America

  • GlaxoSmithKline, Uxbridge, United Kingdom

  • GlaxoSmithKline, Research Triangle Park, NC, United States.

Locations

  • Italy

  • United States

  • Japan

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • Endocrine/metabolic Diseases (ME)

  • Autoimmune (AI)

Disease

  • Lupus

  • Albuminuria

Biomarkers

  • Somatostatin

Drug/Treatment

  • Belimumab

Outcome

  • N/A


Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Controlled

Phase

  • II

Study Id's

  • NCT01649765

Sponsors

  • Abbvie

Result

  • N/A