Last updated on March 2019

Have you or anyone you know been diagnosed with Systemic Lupus Erythematosus?


Brief description of study

Systemic lupus erythematosus (SLE) is a chronic, often debilitating, multisystem, autoimmune disease that is characterized by the presence of certain cells which directly damage the body’s cells and tissues. SLE can affect multiple organ systems simultaneously or sequentially, and follows a highly variable clinical course where periods of relatively stable disease are followed by flares and/or periods of persistently active disease; all of which can ultimately lead to irreversible damage to tissues and organ systems.

In a recently completed Phase 2 study (I4V-MC-JAHH [JAHH]), baricitinib (the study drug) demonstrated clinical efficacy in patients with SLE. Baricitinib plus standard of care was superior to placebo plus standard of care in the proportion of patients achieving remission of rash and/or arthritis.

Given the efficacy of baricitinib demonstrated in clinical trials for treating autoimmune/autoinflammatory diseases involving joints, skin, and kidney (including SLE), the acceptable safety profile of baricitinib observed through the current stage of development, and a continuing unmet medical need in patients with SLE, there is a compelling rationale for the initiation of a Phase 3 program to evaluate baricitinib in treatment of SLE.

 

Clinical Study Identifier: TX215733

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New Horizon Research Center

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