Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: Findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study

2008 ◽  
Vol 58 (11) ◽  
pp. 3319-3329 ◽  
Author(s):  
Edward Keystone ◽  
Désireé Van Der Heijde ◽  
David Mason ◽  
Robert Landewé ◽  
Ronald Van Vollenhoven ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Active Rheumatoid Arthritis ◽  
Certolizumab Pegol ◽  
Phase Iii ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group Study ◽  
Parallel Group

scholarly journals Apremilast in Patients With Active Rheumatoid Arthritis: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

2015 ◽  
Vol 67 (7) ◽  
pp. 1703-1710 ◽  
Author(s):  
Mark C. Genovese ◽  
Katerina Jarosova ◽  
Dorota Cieślak ◽  
Jeffrey Alper ◽  
Alan Kivitz ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Phase Ii ◽  
Active Rheumatoid Arthritis ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group Study ◽  
Parallel Group

scholarly journals Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate

2017 ◽  
Vol 77 (4) ◽  
pp. 488-494 ◽  
Author(s):  
Hiroaki Matsuno ◽  
Masato Tomomitsu ◽  
Atsushi Hagino ◽  
Seonghye Shin ◽  
Jiyoon Lee ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Active Rheumatoid Arthritis ◽  
Reference Product ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acr20 Response ◽  
American College Of Rheumatology ◽  
Parallel Group ◽  
Registration Number

ObjectiveTo evaluate the similarities between LBEC0101 (etanercept biosimilar) and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid arthritis despite methotrexate treatment.MethodsThis phase III, multicentre, randomised, double-blind, parallel-group, 54-week study was conducted in Japan and Korea. The primary efficacy endpoint was the change from baseline in the disease activity score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) at week 24. American College of Rheumatology 20% (ACR20) response rate, adverse events (AEs), pharmacokinetics and development of antidrug antibodies (ADAs) were also evaluated.ResultsIn total, 374 patients were randomised to LBEC0101 (n=187) or ETN-RP (n=187). The least squares mean changes from baseline in DAS28-ESR at week 24 in the per-protocol set were −3.01 (95% CI −3.198 to −2.820) in the LBEC0101 group and −2.86 (95% CI −3.051 to −2.667) in the ETN-RP group. The estimated between-group difference was −0.15 and its 95% CI was −0.377 to 0.078, which was within the prespecified equivalence margin of −0.6 to 0.6. ACR20 response rates at week 24 were similar between the groups (LBEC0101 93.3% vs ETN-RP 86.7%). The incidence of AEs up to week 54 was comparable between the groups (LBEC0101 92.0% vs ETN-RP 92.5%), although fewer patients in the LBEC0101 group (1.6%) than the ETN-RP group (9.6%) developed ADAs.ConclusionThe clinical efficacy of LBEC0101 was equivalent to that of ETN-RP. LBEC0101 was well tolerated and had a comparable safety profile to ETN-RP.Trial registration numberNCT02357069.

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