GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Summary

The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.

Timeline

Start

2011-01

Primary completion

2016-01

Completion

2016-11

Outcome

Met primary endpoint

paper The 90% CI of the geometric mean ratio of the AUCs were within the bioequivalence limits of 80% to 125% for all three comparisons; PMID 28637670 ↗

release “The confirmatory PK and PD study in patients with RA met its primary endpoint by demonstrating PK bioequivalence and PD equivalence” novartis.com ↗

Publications

• Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GP2013	Unknown	1000 mg	Intravenous
Comparator	Rituximab	Monoclonal antibody	1000 mg	Intravenous

Indications