This clinical trial is focused on studying the effects of a medication called belimumab in adults with a condition known as Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease where the body’s immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The medication being tested, belimumab, is administered as a solution for injection using a pre-filled pen. The purpose of the study is to evaluate how effective and safe belimumab is when given to patients with early stages of SLE.
Participants in the study will receive belimumab through subcutaneous injections, which means the medication is injected under the skin. The study will observe participants over a period of time to see how well the medication works in controlling the symptoms of SLE and whether it helps achieve a state called LLDAS, which stands for Low Lupus Disease Activity State, by week 52. The study will also monitor the safety of the medication and any side effects that may occur during the treatment period.
The study will continue to follow participants for up to 156 weeks to gather more information on the long-term effects of belimumab. This includes checking if participants can maintain a stable condition without severe flare-ups and if they can reduce their use of other medications like prednisone, a type of steroid. The trial aims to provide valuable insights into the management of SLE with belimumab, potentially improving treatment options for those affected by this chronic condition.



France
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Greece
Italy
Portugal
Spain