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NOR-SWITCH study design

Study design2

NOR-SWITCH was a national, randomised, double-blind, non-inferiority, parallel-group study that compared the effect of switching from Remicade™‡(infliximab) to INFLECTRA®/CT-P13§ (infliximab) in 482 patients, 248 of whom were diagnosed with IBD#2

Created from Jørgensen KK, et al. 2017.

 

*CT-P13 was designed with comparable efficacy, safety and quality to reference infliximab, to increase the treatment options for your Crohn’s disease and ulcerative colitis patients.5,6 Increasing real-world experience confirms the CT-P13 clinical efficacy and safety profile.7

†Commissioned by Norwegian regional health trusts and fully funded by Norwegian government.

‡Remicade is a registered trademark of MSD.

§CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA™.

#Only single one-way switching from Remicade™ to infliximab/CT-P13 was examined in this study.

 

CD, Crohn’s disease; ECCO, European Crohn’s and Colitis Organisation; IBD, Inflammatory bowel disease; PsA, Psoriatic arthritis; PsO, Psoriasis; RA, Rheumatoid arthritis; SpA, Spondyloarthritis; UC, Ulcerative colitis.

Šaltiniai:

1. Gecse KB, et al. J Crohns Colitis 2016;10(2):133-40. 2. Jørgensen KK, et al. Lancet 2017;389:2304-16. 3. QuintilesIMS. MIDAS, February 2017. 4. INFLECTRA® Summary of Product Characteristics. 5. European Public Assessment Report: INFLECTRA™. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_asses.... Accessed December 2017. 6. European Medicines Agency. Guidelines on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/ 2012/06/WC500128686.pdf. Accessed December 2017. 7. Danese S, et al. J Crohns Colitis 2017;11:26-34.