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Hospira Shares Results From Two Open-label Extension Studies for Biosimilar Infliximab in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis
Date:10/31/2013

ETRA (Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients)
PLANETRA was a prospective, randomized, double-blind, multicenter, parallel-group, Phase III trial that evaluated CT-P13 (infliximab) biosimilar product relative to the Remicade (infliximab) reference product in 606 patients with active rheumatoid arthritis who were not receiving adequate response to methotrexate alone over at least 3 months. The primary objective of the study was to demonstrate efficacy equivalence between CT-P13 and Remicade groups up to Week 30, as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20). Secondary objectives of this study were to evaluate long-term efficacy, pharmacokinetics, pharmacodynamics, and overall safety of CT-P13 in comparison with Remicade up to Week 54.

PLANETRA is registered on ClinicalTrials.gov and can be accessed at: http://www.clinicaltrials.gov/ct2/show/NCT01217086?term=ct-p13&rank=4

About PLANETAS (Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients)
PLANETAS was a prospective, randomized, double-blind, multicenter, parallel-group Phase I trial which evaluated CT-P13 (infliximab) biosimilar product relative to the Remicade (infliximab) reference product in 250 patients with active ankylosing spondylitis. The primary objective of this study was to demonstrate comparable pharmacokinetics at steady state between CT-P13 and Remicade groups up to Week 30, as measured by area under the concentration-time curve over a dosing interval (AUC) and observed maximum serum concentration at steady state (Cmax,ss). Secondary objectives of this study were to assess the long-term efficacy, pharmacokinetics, and overall safety of CT-P13 in comparison with Remicade for up to Week 54.

PLANETAS is registered
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SOURCE Hospira, Inc.
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