Complexo Hospitalario Universitario De Vigo
Vigo, Spain
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a medication called Upadacitinib on individuals with Systemic Lupus Erythematosus (SLE), a condition where the immune system mistakenly attacks healthy tissues in the body, causing inflammation and damage. The study aims to evaluate the safety and effectiveness of Upadacitinib, which is taken as a modified-release tablet, in adults who have moderate to severe SLE. Participants in the study will either receive Upadacitinib or a placebo, which is a substance with no active medication, to compare the outcomes.
The purpose of the study is to assess how well Upadacitinib works in reducing the signs and symptoms of SLE over a period of 52 weeks. The study is divided into two main parts: the first part involves two similar studies that will last for 52 weeks, and the second part is a long-term extension to further evaluate the safety of Upadacitinib. Participants will be monitored regularly to track any changes in their condition and to ensure their safety throughout the study.
During the trial, participants will continue their usual background treatments for SLE, which may include medications like hydroxychloroquine or prednisone, among others. The study will measure various outcomes, such as the reduction in disease activity and improvement in symptoms, to determine the effectiveness of Upadacitinib compared to the placebo. The trial is expected to provide valuable information on the potential benefits of Upadacitinib for people living with SLE.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
8 criteria
427 criteria
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Vigo, Spain
Tallin, Estonia
Cluj Napoca, Romania
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