A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy

Annals of the Rheumatic Diseases

Volumn 76, Issue 1, 2017, Pages 58-64

  Choe, Jung Yoon ^a   Prodanovic, Nenad ^b   Niebrzydowski, Jaroslaw ^c   Staykov, Ivan ^d   Dokoupilova, Eva ^e   Baranauskaite, Asta ^f   Yatsyshyn, Roman ^g   Mekic, Mevludin ^h   Porawska, Wieskawa ⁱ   Ciferska, Hana ^j   Jedrychowicz Rosiak, Krystyna ^k   Zielinska, Agnieszka ^l   Choi, Jasmine ^m   Rho, Young Hee ^m   Smolen, Josef S ⁿ  

^a The Catholic University of Korea   (South Korea)

^b Clinical Center of Banja Luka   (Bosnia and Herzegovina)

^c Medica Pro Familia   (Poland)

^d MHAT Dr Ivan Seliminski   (Bulgaria)

^e MEDICAL PLUS sro   (Czech Republic)

^f LITHUANIAN UNIVERSITY OF HEALTH SCIENCES   (Lithuania)

^g IVANO FRANKIVSK NATIONAL MEDICAL UNIVERSITY   (Ukraine)

^h University Clinical Centre of Sarajevo   (Bosnia and Herzegovina)

ⁱ Poznanski Osrodek Medyczny Novamed   (Poland)

^j CHARLES UNIVERSITY   (Czech Republic)

^k MCBK SC   (Poland)

^l Medica Pro Familia Sp z oo Spolka Komandytowo Akcyjna   (Poland)

^m Samsung Bioepis Co Ltd   (South Korea)

ⁿ MEDICAL UNIVERSITY OF VIENNA   (Austria)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BIOSIMILAR AGENT; DRUG ANTIBODY; INFLIXIMAB; METHOTREXATE; SB 2; UNCLASSIFIED DRUG; ANTIBODY; ANTIRHEUMATIC AGENT;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BACTERIAL PNEUMONIA; BREAST CANCER; BRONCHITIS; CELLULITIS; CONTROLLED STUDY; COUGHING; DELAYED HYPERSENSITIVITY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FATALITY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; ENTERITIS; ERYSIPELAS; FEMALE; FEVER; HEADACHE; HEART FAILURE; HUMAN; HYPERTENSION; IMMUNOGENICITY; INFECTION; INFUSION RELATED REACTION; LATENT TUBERCULOSIS; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MINIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; OPPORTUNISTIC INFECTION; PHARYNGITIS; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PROSTATE CANCER; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SERUM SICKNESS; SIDE EFFECT; SOFT TISSUE INFECTION; TUBERCULOSIS; TUBERCULOUS PLEURISY; UNSPECIFIED SIDE EFFECT; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; WOUND INFECTION; AGED; ARTHRITIS, RHEUMATOID; BLOOD; CLINICAL TRIAL; COMPARATIVE STUDY; IMMUNOLOGY; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCE; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFLIXIMAB; MALE; METHOTREXATE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 84941584714     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2015-207764     Document Type: Article

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