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Clinical trials

Clinical trials

Remsima® SC demonstrated comparable efficacy and safety to infliximab IV administration
with stable potency and immunogenicity benefits.1

Healthy Subjects Crohn’s Disease, Ulcerative Colitis Rheumatoid Arthritis
1.5
Pilot Study
(Phase Ⅰ)
1.6
IBD Study
(Phase Ⅰ/Ⅲ)
3.5
RA Study
(Phase Ⅰ/Ⅲ)
- Part 1
(Dose finding)
Part 2
(NI test)
Part 1
(Dose finding)
Part 2
(NI test)
Remsima® SC was feasible in terms of bioavailability and safety.4 1 year result of Remsima® SC treatment showed comparable efficacy and safety with Remsima® IV in CD patients.5,6 1 year result in active CD and UC showed that comparable efficacy and safety of two formulations were maintained even after switching from IV to SC route.1,7 1 year result of Remsima® SC treatment showed comparable efficacy and safety with Remsima® IV in RA patients.8,9 1 year result in active RA showed that comparable efficacy and safety of two formulations were maintained even after switching from IV to SC route.10
See details See details See details See details See details

References

1. Ben-Horin S et al., ECCO 2020 abstract No.OP24

2. Remsima® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/Remsima®-epar-product-information_en.pdf Accessed 4 Sep 2020.

3. Cha JM et al., Journal Korean Med Sci 2017;32:85–94

4. Westhovens R et al., UEG J 2017, abstract No.297.

5. Reinisch W et al., ECCO 2019 Congress, abstract No.DOP62.

6. Ye BD et al., DDW 2019 Congress, abstract No.Tu1715.

7. Schreiber S et al., UEGW 2019 Congress abstract No.LB02.

8. Westhovens R et al., Ann Rheum Dis 2018;77:315.

9. Yoo DH et al., EULAR 2019 Congress poster No.FRI0128.

10. Westhovens R et al., ACR 2019 Congress abstract No.548.

Abbreviations

CD, Crohn’s disease; EMA, European Medicines Agency; IBD, inflammatory bowel disease; IV, intravenous; NI, non-inferiority; RA, rheumatoid arthritis; SC, subcutaneous; UC, ulcerative colitis;