Studier

Studier innen reumatologi 

Fase III registreringsstudier

PLANETRA Study
Yoo DH, Hrycaj P, Miranda P, et al.  A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Annals of the Rheumatic Diseases 2013;72:1613-1620.

PLANETRA Extension Study
Yoo DH, Prodanovic N, Jaworski J, et al.  Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study.  Annals of the Rheumatic Diseases 2017;76:355-363.

PLANETAS Study
Park W, Hrycaj P, Jeka S, et al.  A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Annals of the Rheumatic Diseases 2013; 72:1605-1612.

PLANETAS Extension Study
Park W, Yoo DH, Miranda P, et al.  Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Annals of the Rheumatic Diseases 2017;76:346-354.

Andre studier innen reumatologi

DANBIO Registry
Glintborg B, Sørensen IJ, Loft AG On behalf of all departments of rheumatology in Denmark, et al.  A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Annals of the Rheumatic Diseases 2017;76:1426-1431.

Cross-reactivity of Antidrug Antibodies
Reinisch W, Jahnsen J, Schreiber S, et al. Evaluation of the Cross-reactivity of Antidrug Antibodies to CT-P13 and Infliximab Reference Product (Remicade): An Analysis Using Immunoassays Tagged with Both Agents. Biodrugs 2017;31(3):223-237.
 

PP-IFA-NOR-0046