A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study.

@article{Bae2017API,
  title={A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study.},
  author={Sang Cheol Bae and Jinseok Kim and Jung Yoon Choe and Won Park and Sang-Heon Lee and Yong Beom Park and Seung Cheol Shim and Shin-Seok Lee and Yoon Kyoung Sung and Chan Bum Choi and Suk-joo Lee and H. Park and Yongho Ahn},
  journal={Annals of the rheumatic diseases},
  year={2017},
  volume={76 1},
  pages={
          65-71
        }
}
OBJECTIVES To evaluate equivalence in efficacy for rheumatoid arthritis (RA) and compare the safety of the biosimilar HD203 with innovator etanercept (ETN) plus methotrexate (MTX) (ClinicalTrials.gov NCT01270997). METHODS Patients with active RA received 25 mg HD203 or ETN subcutaneously twice-weekly with MTX for 48 weeks in a phase III, multicentre, randomised, double-blind, parallel-group design. The primary end point was the proportion of patients achieving the American College of… CONTINUE READING
3
Twitter Mentions

Similar Papers

Citations

Publications citing this paper.
SHOWING 1-10 OF 15 CITATIONS

Focus on biosimilar etanercept – bioequivalence and interchangeability

  • Biologics : targets & therapy
  • 2018
VIEW 5 EXCERPTS
CITES RESULTS
HIGHLY INFLUENCED

References

Publications referenced by this paper.
SHOWING 1-10 OF 40 REFERENCES

The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis

DH Yoo
  • Expert Rev Clin Immunol
  • 2014