NOR-SWITCH study design

NOR-SWITCH var en nasjonal, randomisert, dobbeltblind, non-inferiority, parallellgruppe studie som sammenlignet effekten av et bytte fra Remicade til Inflectra/CT-P13 (infliksimab) hos 482 pasienter, hvorav 248 var diagnostisert med IBD. #1

Adaptert fra Jørgensen KK, et al. 2017.

Inklusjonskriterier:

  • Klinisk diagnose av RA,SpA,PsA,UC,CD eller PsO
  • Voksne menn eller kvinner (ikke gravide eller ammende)
  • Stabil behandling med Remicade siste 6 måneder

 
Primær endepunkt:

  • Forverring av sykdom, uavhengig av indikasjon ved uke 52
     
Footnotes
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.
Referanser:

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 SPC, 28.08.2019, 5. European Public Assessment Report: INFLECTRA®. Available here. Accessed 23.09.2019, 6. European Medicines Agency. Guidelines on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. Available here. Accessed 23.09.2019, 7. Yoo DH. Expert Rev Clin Immunol 2017;13(7):653-66, 8. Danese S, et al. Aliment Pharmacol Ther 2011;33:857-69, 9. Moss AC. Gastroenterol Rep 2015;3(1):63-8, 10. FDA. CBER approval letter, infliximab. 1998. Available here. Accessed 23.09.2019, 11. EMA. Public Statement on Remicade (infliximab). 2000. Available here. Accessed 23.09.2019, 12. Medscape. [Public Release: 22 September 2005]. https://www.medscape.com/viewarticle/513282. Accessed 23.09.2019 13. EMA. Remicade Scientific Discussion. 2006, 14. Centocor, Inc. [Public Release: 6 November 2007]. https://www.eurekalert.org/pub_releases/2007-11/ci-rbf110607.php. Accessed 23.09.2019, 15. Remicade (infliximab). www.remicade.com. Accessed 23.09.2019, 16. Gomollon F, et al. J Crohns Colitis 2016;1-26, 17. Dignass A, et al. J Crohns Colitis 2012;6:991-1030, 18. Danese S, et al. J Crohns Colitis 2017;11:26-34, 19. Kim YH, et al. Abstract LB04, UEGW 2017. United European Gastroenterol J 2017;5:1139-40, 20. Fiorino G, et al. Inflamm Bowel Dis 2017;23:233-43, 21. Farkas K, et al. J Crohns Colitis 2016;10:1273-8, 22. Hlavaty T, et al. Gastroenterol Hepatol 2016;70:27-32, 23. Jahnsen J, et al. Expert Rev Gastroenterol Hepatol 2015;9(S1):S45-52, 24. Keil R, et al. Scand J Gastroenterol 2016;51:1062-8, 25. UK inflammatory bowel disease (IBD) programme steering group. Royal College of Physicians, UK. IBD Biological Therapy Audit 2016. Available here. Accessed 23.09.2019, 26. Razanskaite V, et al. J Crohns Colitis 2017 Jan 27 epub, 27. Smits LJ, et al. J Crohns Colitis 2016;10:1287-93, 28. ClinicalTrials.gov. NCT02096861. Available here. Accessed 23.09.2019, 29. Kim YH, et al. Abstract 101, AOCC 2017, 30. EUDRA CT 2013-004497-10 CT-P13 3.4 trial record. Available here. Accessed 23.09.2019, 31. Kim YH, et al. Abstract DOP061, ECCO 2017. J Crohns Colitis 2017;11/Supp 1:S62

PP-IFA-NOR-0042