Study 3.443 was a randomised, double-blind, parallel-group, phase 3 study to demonstrate non-inferiority in efficacy and to assess safety of Inflectra®/CT-P13* (infliximab) compared to Remicade®† in 220 patients with active CD42-43.

Study design39,41-43

Study 3.4: Study Design

Efficacy

The study met its primary endpoint, demonstrating the non-inferiority of CT-P13 compared with those who have recieved Remicade® at Week 639-41.

Patients who recieved CT-P13 compared with those who recived Remicade® also achieved similar rates of CDAI-100 response and clinical remission at week 641.

Study 3.4: Efficacy Results at Week 6

Study results (week 54) indicated similar efficacy in patients switched (at week 30) from Remicade® to CT-P13* compared with those who remained on Remicade®‡ 42.

Efficacy among patients maintained on Remicade® and those switched to CT-P13* at Week 3042

Study 3.4: Efficacy Results at Week 30

 

Safety Results

The study showed that CT-P13* has a similar long-term (54-week) safety profile to Remicade® in patients with CD42.

Safety Results up to Week 54#42

Study 3.4: Safety Results

Study 3.4: Safety Conclusion

Prescribing Information 

Inflectra® Summary of Product Characteristics   |   Legal Category: POM  Basic NHS Price: 1 vial £377.66

*CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA®.
§ADA positive.
†Remicade® is a registered trademark of MSD.
# Secondary endpoint; not powered to show difference in switch groups.
‡ 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.

CDAI, Crohn’s Disease Activity Index; CD, Crohn’s disease; CI, Confidence interval; RCT, Randomised controlled trial.

 

PP-IFA-GBR-0304. December 2018