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

Annals of the Rheumatic Diseases

Volumn 77, Issue 4, 2018, Pages 488-494

  Matsuno, Hiroaki ^a,b   Tomomitsu, Masato ^c   Hagino, Atsushi ^c   Shin, Seonghye ^d   Lee, Jiyoon ^d   Song, Yeong Wook ^e,f  

^a Matsuno Clinic for Rheumatic Diseases   (Japan)

^b TOKYO MEDICAL UNIVERSITY   (Japan)

^c Mochida Pharmaceutical   (Japan)

^d LG Chemical Ltd   (South Korea)

^e Seoul National University   (South Korea)

^f Seoul National University Hospital   (South Korea)

Author keywords

Das28; Methotrexate; Rheumatoid Arthritis

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; ETANERCEPT; LBEC 0101; METHOTREXATE; ANTIRHEUMATIC AGENT; IMMUNOGLOBULIN G; LBEC0101; TUMOR NECROSIS FACTOR RECEPTOR;

ADULT; AMERICAN COLLEGE OF RHEUMATOLOGY 20; ARTHRALGIA; ARTICLE; BACKACHE; CONSTIPATION; CONTROLLED STUDY; COUGHING; DAS28; DEATH; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; HEADACHE; HEART FAILURE; HUMAN; IMMUNOGENICITY; INFECTION; INJECTION SITE ERYTHEMA; INJECTION SITE PRURITUS; INJECTION SITE SWELLING; INTERSTITIAL LUNG DISEASE; JAPAN; LATENT TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MALIGNANT NEOPLASM; MINIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE ASSESSMENT; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SEPSIS; SIDE EFFECT; SOUTH KOREA; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; AGED; BLOOD; CLINICAL TRIAL; LEAST SQUARE ANALYSIS; METABOLISM; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCE; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; BLOOD SEDIMENTATION; DOUBLE-BLIND METHOD; ETANERCEPT; FEMALE; HUMANS; IMMUNOGLOBULIN G; LEAST-SQUARES ANALYSIS; MALE; METHOTREXATE; MIDDLE AGED; RECEPTORS, TUMOR NECROSIS FACTOR; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85044836105     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2017-212172     Document Type: Article

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