A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis

Annals of the Rheumatic Diseases

Volumn 76, Issue 9, 2017, Pages 1598-1602

  Smolen, Josef S ^a   Cohen, Stanley B ^b   Tony, Hans Peter ^c   Scheinberg, Morton ^d   Kivitz, Alan ^e   Balanescu, Andra ^f   Gomez Reino, Juan ^g   Cen, Liyi ^h   Zhu, Peijuan ^h   Shisha, Tamas ^h  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b METROPLEX CLINICAL RESEARCH CENTER   (United States)

^c UNIVERSITY OF WÜRZBURG   (Germany)

^d HOSPITAL ISRAELITA ALBERT EINSTEIN   (Brazil)

^e Altoona Center for Clinical Research   (United States)

^f CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^g University Hospital of Santiago de Compostela   (Spain)

^h Sandoz Pharma Ltd   (Switzerland)

Author keywords

B cells; DMARDs (biologic); Rheumatoid arthritis

Indexed keywords

BIOSIMILAR AGENT; FOLIC ACID; METHOTREXATE; METHYLPREDNISOLONE; RITUXIMAB; RIXATHON; UNCLASSIFIED DRUG; ANTIRHEUMATIC AGENT; VITAMIN B COMPLEX;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BODY MASS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DAS28; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG INFUSION; DRUG OVERDOSE; DRUG RESPONSE; DRUG SAFETY; FEMALE; HUMAN; HUMORAL IMMUNE DEFICIENCY; IMMUNOGENICITY; INFUSION RELATED REACTION; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE ORGAN FAILURE; OUTCOME ASSESSMENT; PARALLEL DESIGN; PERICARDITIS; PHYSICAL CHEMISTRY; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; ADOLESCENT; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMBINATION DRUG THERAPY; THERAPEUTIC EQUIVALENCE; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIRHEUMATIC AGENTS; AREA UNDER CURVE; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FOLIC ACID; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; RITUXIMAB; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME; VITAMIN B COMPLEX; YOUNG ADULT;

EID: 85024911420     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2017-211281     Document Type: Article

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