Publications by authors named "G R Burmester"
Objective: To optimise the organisation of care and encourage the adoption of good clinical practices, the RarERN Path methodology was designed within ERN ReCONNET. The aim of our work was to report the application of RarERN Path on systemic sclerosis within the ERN ReCONNET centres, providing a feasible and flexible organisational reference model for optimising the systemic sclerosis care pathway in different countries.
Methods: RarERN Path is a six-phase methodology which enables the creation of a reference organisational model co-designed on the basis of the expertise of different stakeholders.
Article Synopsis
- The study aimed to show that CT-P47 is as effective as the EU-approved tocilizumab (r-TCZ) in treating rheumatoid arthritis (RA) patients.
- Conducted as a double-blind, phase III trial, 471 patients were randomized to receive either CT-P47 or r-TCZ, with efficacy measured primarily through changes in Disease Activity Score at specified weeks.
- Results indicated that both treatments had similar efficacy, pharmacokinetics, safety, and immunogenicity profiles, confirming CT-P47's equivalence to r-TCZ even after patients switched from r-TCZ to CT-P47.
CT-P47 is a candidate biosimilar of tocilizumab. This 12-week, randomized, double-blind, parallel-design, phase 1 study aimed to demonstrate pharmacokinetic (PK) equivalence of CT-P47 and reference tocilizumab. Participants were healthy Japanese adults aged 18-55 years.
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