Saphnelo for Systemic Lupus Erythematosus
This study observes the occurrence of adverse reactions in people with systemic lupus erythematosus who are taking Saphnelo, focusing on safety concerns like infections and allergic reactions.
Data Collection
Collected from today forward - ProspectiveAutoimmune Diseases+2
+ Connective Tissue Diseases
+ Immune System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: December 21, 2021
Actual date on which the first participant was enrolled.This study aims to gather information about the long-term safety and effectiveness of a medicine called Anifrolumab in patients with systemic lupus erythematosus (SLE), a condition where the immune system attacks healthy tissue. The study focuses on patients who do not respond well to existing treatments. This is important because it can help determine if Anifrolumab is a safe and effective option for these patients in real-life settings, potentially providing a new avenue for managing their condition. Participants in the study will receive Anifrolumab through an intravenous infusion, which means the medicine will be delivered directly into their bloodstream. The study will monitor the occurrence of adverse drug reactions (ADRs), which are unwanted effects from the medication. Specifically, it looks at the likelihood of issues such as herpes zoster, serious infections, allergic reactions, cancer, and hepatitis B virus reactivation. Understanding these risks is crucial to ensure the treatment's safety for long-term use.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1620 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 47 locations
Research Site
Akita, JapanResearch Site
Aomori, JapanResearch Site
Chiba, Japan