Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study

@inproceedings{Urowitz2015SafetyAE,
  title={Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study},
  author={Murray B. Urowitz and David Alan Isenberg and Daniel Wallace},
  booktitle={Lupus science & medicine},
  year={2015}
}
OBJECTIVE To evaluate the safety and efficacy of hCDR1 (Edratide) in patients with systemic lupus erythematosus (SLE). METHODS Patients (n=340) with SLE ≥4 ACR criteria (4-11, mean 7) with active disease (SLEDAI-2K of 6-12). Patients were on average 7.1 years post-diagnosis and their organ involvement was mainly musculoskeletal, mucocutaneous and haematologic. Placebo or Edratide was administered subcutaneously weekly at doses of 0.5, 1.0 or 2.5 mg. The co-primary endpoints were SLEDAI-2K SLE… CONTINUE READING

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