A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study

Arthritis Research and Therapy

Volumn 18, Issue 1, 2016, Pages

  Yoo, Dae Hyun ^a   Racewicz, Artur ^b   Brzezicki, Jan ^c   Yatsyshyn, Roman ^d   Arteaga, Edgardo Tobias ^e   Baranauskaite, Asta ^f   Abud Mendoza, Carlos ^g   Navarra, Sandra ^h   Kadinov, Vladimir ⁱ   Sariego, Irmgadt Goecke ^j   Hong, Seung Suh ^k   Lee, Sung Young ^k   Park, Won ^l  

^a Hanyang University College of Medicine   (South Korea)

^b NZOZ Center for Medical Genetics   (Poland)

^c Zaklad Rentgenodiagnostyki   (Poland)

^d Clinical Immunology and Allergology   (Ukraine)

^e HOSPITAL MILITAR CENTRAL   (Colombia)

^f LITHUANIAN UNIVERSITY OF HEALTH SCIENCES   (Lithuania)

^g HOSPITAL CENTRAL DR IGNACIO MORONES PRIETO   (Mexico)

^h ST LUKE S MEDICAL CENTER   (Philippines)

ⁱ UNIVERSITY HOSPITAL ST MARINA   (Bulgaria)

^j Prosalud y Cia Ltda   (Chile)

^k CELLTRION   (South Korea)

^l Inha University Hospital   (South Korea)

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Author keywords

ACR20; Biosimilar; CT P13; Efficacy; Immunogenicity; Infliximab; Pharmacokinetics; Rheumatoid arthritis; Safety; Sharp score

Indexed keywords

ANTIRHEUMATIC AGENT; BIOSIMILAR AGENT; CT P13; DRUG ANTIBODY; INFLIXIMAB; METHOTREXATE; UNCLASSIFIED DRUG; CT-P13; MONOCLONAL ANTIBODY;

ADULT; AGED; ANEMIA; ARTICLE; BONE RADIOGRAPHY; CLINICAL DISEASE ACTIVITY INDEX; CONTROLLED STUDY; DAS28; DISEASE ACTIVITY; DISEASE COURSE; DISEASE EXACERBATION; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEVER; HEADACHE; HERPES VIRUS INFECTION; HUMAN; INFUSION RELATED REACTION; LATENT TUBERCULOSIS; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAIN; PHARMACODYNAMICS; PHASE 3 CLINICAL TRIAL; PHYSICAL CAPACITY; RANDOMIZED CONTROLLED TRIAL; RASH; RHEUMATOID ARTHRITIS; SHORT FORM 36; SIDE EFFECT; SIMPLIFIED DISEASE ACTIVITY INDEX; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; ADOLESCENT; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFLIXIMAB; MALE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84962037330     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/s13075-016-0981-6     Document Type: Article

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