Skip directly to content

Study 3.4 design

Study 3.4 was a randomised, double-blind, parallel-group, Phase 3 study to demonstrate non-inferiority in efficacy and to assess safety of INFLECTRA®/CT-P13 (infliximabum) compared to Remicade™ (infliximabum) in 220 patients with active CD5,6

Study design6-8

Created from Kim YH, et al. UEGW 2017, Kim YH, et al. ECCO 2017, and Kim YH, et al. AOCC 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.9,10 Increasing real-world experience confirms the CT-P13 clinical efficacy and safety profile.11

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

‡Remicade™ is a registered trademark of MSD.

CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; ECCO, European Crohn’s and Colitis Organisation; IBD, Inflammatory bowel disease; TNF-α, Tumour necrosis factor-alpha; SIBDQ, Short Inflammatory Bowel Disease Questionnaire.

 

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. ClinicalTrials.gov. NCT02096861. Available at: https://clinicaltrials.gov/ct2/show/NCT02096861?term=CT-P13&rank=1. Accessed December 2017. 6. Kim YH, et al. Abstract LB04, UEGW 2017. United European Gastroenterol J 2017;5:1139-40. 7. Kim YH, et al. Abstract DOP061, ECCO 2017. J Crohns Colitis 2017;11/Supp 1:S62. 8. Kim YH, et al. Abstract 101, AOCC 2017. 9. European Public Assessment Report: INFLECTRA™. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_asses.... Accessed December 2017. 10. 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. 11. Danese S, et al. J Crohns Colitis 2017;11:26-34.