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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: Symptoms, Treatment, Causes

A combination of genetic risk factors (such as variations in human leukocyte antigen genes) and environmental factors (such as infections or occupational exposure to certain kinds of fibers) may trigger the development of RA. An autoimmune malfunction may begin in other parts of the body, but the effects eventually center on the joints. The inflammation of the synovium stays persistent, leading it to thicken and eventually cause pain and redness.

Abandoned therapies and unpublished trials in rheumatoid arthritis

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 | RA

Treatments and Therapies ; Start Here ; Diagnosis and Tests ; Living With ; Related Issues ; Specifics ; Statistics and Research ; Journal Articles ; Find an Expert

Jae joon Lee

Factors associated with radiographic progression in patients with Takayasu's arteritis ; Menopausal factors and risk of seropositive rheumatoid arthritis in postmenopausal women a nationwide cohort study of 1.36 million women ; Machine learning to predict early TNF inhibitor users in patients with ankylosing spondylitis

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...

Rheumatoid arthritis | Nature Reviews Disease Primers

The immunopathogenesis of seropositive rheumatoid arthritis: from triggering to targeting., 60–75 (2017).Myasoedova, E., Crowson, C. S., Kremers, H. M., Therneau, T. M. & Gabriel, S. E....

Clinical Trials | Incannex

Our Active Patient Trial Sites ; IHL-42X · Obstructive Sleep Apnoea · Clinical Trial Overview · RePOSA study The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea who are intolerant, non-compliant, or naïve to positive airway pressure. This study is being conducted at sites in the United States and will expand to sites in Europe and the United Kingdom in 2025. Find your trial site ...

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

Rheumatoid arthritis (RA) is a chronic, heterogeneous disease, for which there has... As a result of these efforts, the efficacy of almost all new agents tested in clinical trials are now...

Rheumatoid Arthritis Diet

Nutrition Facts · Amount per serving ; calories : 527, total fat : 31g, saturated fat : 10g, protein : 40g, carbohydrates : 9g, fiber : 0.9g, sugar : 5.2g, added sugar : 0g, sodium : 486mg

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