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FDA approves Celltrion's phase 3 trial of Zymfentra for rheumatoid arthritis < Pharma < Article

Celltrion said Monday that the U.S. Food and Drug Administration (FDA) has approved a phase 3 clinical trial of its Remicade biosimilar, Zymfentra (CT-P13 SC, infliximab), for the indication of rheumatoid arthritis (RA). Celltrion will analyze the efficacy and safety of Zymfentra vs. placebo in 189 patients with RA. Zymfentra is a subcutaneous (SC) formulation of infliximab, a tumor necrosis factor (TNF)-α inhibitor developed by Celltrion. Celltrion launched Zymfentra in the U.S. in March and has signed agreements with prominent pharmacy benef ...

Rheumatoid Arthritis Tied to Higher Risk for Lung Cancer - Drugs.com MedNews

Rheumatoid arthritis (RA) is associated with a significantly increased risk for lung cancer, according to a study published online July 28 in Arthritis Rheumato

Abandoned therapies and unpublished trials in rheumatoid arthritis

developed for treatment of rheumatoid arthritis, few have been approved for use. Most of the agents have failed to reach the approval stage because of inadequate clinical...

Rheumatoid arthritis | Nature Reviews Disease Primers

High-density genetic mapping identifies new susceptibility loci for rheumatoid arthritis., 1336–1340 (2012).Begovich, A. B. . A missense single-nucleotide polymorphism in a gene encoding...

Rheumatoid Arthritis | RA

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Rheumatoid Arthritis

Michael George, MD Institution: University of Pennsylvania Grant title: Genetic predictors of metabolic adverse effects with glucocorticoid treatment in patients with rheumatoid arthritis Award mechanism: Pilot award Amount awarded: $150,000 Award duration: 1 year Read more about Dr. George ; Wen-Yuan Elena Hsieh, MD Institution: University of Colorado, Denver Grant title: Immunological determinants of the development of clinical rheumatoid arthritis evaluated in the pre-RA and early stages of d...

Issues in the design of new clinical trials for rheumatoid arthritis therapeutic

Since 1998, six new drugs have been approved for the treatment of rheumatoid arthritis, with the hope of at least two more in the next year—a unique success story in terms of drug approval for one...

Update on methotrexate as the anchor drug for rheumatoid arthritis

Methotrexate has become the "anchor drug" for rheumatoid arthritis (RA), taken by many more patients than any other disease modifying anti-rheumatic drug (DMARD) or biological agent. Methotrexate h...

Etanercept for the treatment of rheumatoid arthritis

Etanercept was the first specific anticytokine therapy approved for the treatment of rheumatoid arthritis (RA). Its clinical efficacy and safety has been demonstrated by several clinical trials in...

Biological agents for rheumatoid arthritis: targeting both physical function and

********@*******.**.** Abstract Rheumatoid arthritis (RA) is a... Ten years after the first clinical trials of anti-TNF therapies, the adverse effect profile is evolving and includes, for...

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