Chugai Pharma Europe LRO 301 IL-6 Trial
- Date:
- 1996-2010
- Reference:
- SA/KET/A/1/9
- Part of:
- The Kennedy Trust for Rheumatology Research
- Archives and manuscripts
Collection contents
About this work
Description
Comprises records relating to the LRO 301 IL-6 trial, "a double blind, randomised parallel group, controlled dose ranging study of the safety, tolerability, pharmacokinetics, and efficacy of repeat doses of MRA given alone or in combination with MTX in patients with RA." The trial is also referred to as CHARISMA.
The aim of the trail was to determine the safety and effectiveness of MRA (humanised anti-human IL-6 receptor monoclonal antibody IgG1) when given alone or in combination with methotrexate. The trial was sponsored by Chugai Pharma Europe Ltd, conducted by the Kennedy Institute of Rheumatology with investigators were Ravinder Maini and Peter Taylor. The trial involved 359 patients from 57 recruiting sites across 14 European countries.