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STUDY 3.4 overview

Study 3.45 is the first RCT in IBD comparing INFLECTRA®/CT-P13 (infliximab) with Remicade™ (infliximab) in patients with active CD6

  • The study met its primary endpoint, proving the non-inferiority of CT-P13 efficacy (CDAI-70) compared with Remicade™ (infliximab) at Week 66,7
  • Study results (Week 54) indicated similar efficacy in patients switched (at Week 30) from Remicade™ (infliximab) to CT-P13 compared with those who remained on Remicade™(infliximab)
    • Statistical data generated from the switch data of Study 3.4 are not powered to demonstrate any comparison and should be treated as descriptive statistics only

Study 3.4 study design

 

Efficacy among patients maintained on Remicade™ (infliximab) and those switched to CT-P13 at Week 308

Clinical remission was defined as an absolute CDAI score of less than 150 points. Created from Kim YH, et al. UEGW 2017.

 

  • The study showed that CT-P13 has a similar long-term (54-week) safety profile to Remicade™ (infliximab) in patients with CD8

 

*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; RCT, Randomised controlled trial.

 

 

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 101, AOCC 2017. 7. EUDRA CT 2013-004497-10 CT-P13 3.4 trial record. Available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004497-10/NL. Accessed December 2017. 8. Kim YH, et al. Abstract LB04, UEGW 2017. United European Gastroenterol J 2017;5:1139-40. 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.

 

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