Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: Results from the phase III randomised VOLTAIRE-RA equivalence study

Annals of the Rheumatic Diseases

Volumn 77, Issue 6, 2018, Pages 914-921

  Cohen, Stanley B ^a   Alonso Ruiz, Alberto ^b   Klimiuk, Piotr A ^c   Lee, Eric C ^d   Peter, Nuala ^e   Sonderegger, Ivo ^e   Assudani, Deepak ^e  

^a METROPLEX CLINICAL RESEARCH CENTER   (United States)

^b HOSPITAL DE CRUCES   (Spain)

^c MEDICAL UNIVERSITY OF BIALYSTOK   (Poland)

^d Inland Rheumatology Clinical Trials   (United States)

^e BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

anti TNF; autoimmune diseases; dmards (biologic); rheumatoid arthritis; treatment

Indexed keywords

ABATACEPT; ADALIMUMAB; BI 695501; BIOSIMILAR AGENT; CERTOLIZUMAB PEGOL; CYCLIC CITRULLINATED PEPTIDE ANTIBODY; DRUG ANTIBODY; ETANERCEPT; GOLIMUMAB; INFLIXIMAB; METHOTREXATE; NEUTRALIZING ANTIBODY; RHEUMATOID FACTOR; RITUXIMAB; TOCILIZUMAB; ANTIRHEUMATIC AGENT;

ADULT; AGED; AMERICAN COLLEGE OF RHEUMATOLOGY RESPONSE CRITERIA; APPENDICITIS; ARTHRITIS; ARTICLE; ASIA; BIOEQUIVALENCE; BRONCHITIS; CELLULITIS; DAS28; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHROCYTE SEDIMENTATION RATE; EUROPE; FEMALE; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); MUSCULOSKELETAL DISEASE ASSESSMENT; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PRIORITY JOURNAL; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; SALMONELLOSIS; SOUTH AND CENTRAL AMERICA; TREATMENT OUTCOME; UNITED STATES; URTICARIA; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; IMMUNOLOGY; MIDDLE AGED; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SENSITIVITY AND SPECIFICITY; SEVERITY OF ILLNESS INDEX; SUBCUTANEOUS DRUG ADMINISTRATION; THERAPEUTIC EQUIVALENCE; VERY ELDERLY; YOUNG ADULT;

ADALIMUMAB; ADULT; AGED; AGED, 80 AND OVER; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; BLOOD SEDIMENTATION; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; SENSITIVITY AND SPECIFICITY; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 85047269926     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2017-212245     Document Type: Article

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