The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability. Study details include: * Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study. * The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study. * The participants will continue to receive anifrolumab the same way they received it in the parent trial * A participant is considered to have completed the study when they meet one of the discontinuation criteria. * Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,072
Anifrolumab pre-filled syringe
Anifrolumab solution for injection in pre-filled pen
Anifrolumab concentrate for solution for infusion
Research Site
Los Angeles, California, United States
Research Site
Fort Lauderdale, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
New York, New York, United States
Research Site
SAEs and Non-Serious AEs
Safety will be evaluated by monitoring and assessing SAEs and Non-Serious AEs as reported throughout the study and until 12 weeks after the last dose of anifrolumab
Time frame: From first dose administered and until 12 weeks after the last dose of Anifrolumab
AstraZeneca Clinical Study Information Center
CONTACT
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Charleston, South Carolina, United States
Research Site
Graz, Austria
Research Site
Graz, Austria
Research Site
Ghent, Belgium
Research Site
Salvador, Brazil
...and 31 more locations