Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTAnifrolumab
Anifrolumab pre-filled syringe
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The rationale of the ROSY-S study is to provide continuous access to study treatment for participants clinically benefiting from anifrolumab treatment upon completion of parent studies and monitoring long-term safety and tolerability of anifrolumab. Participants will be enrolled into this study based upon the parent study continuing to receive the same treatment dose and regimen throughout until they meet one of the treatment discontinuation criteria.
Eligibility
Sex/Gender
ALL
Age
5 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants are eligible to be included in the study only if all of the following criteria apply: 1 Participants must have completed the entirety of the parent study and should have received at least one dose of anifrolumab in the parent study. * In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants should continue following the contraception requirements as per Appendix B from study enrolment up to 16 weeks after the last dose of study treatment. * Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Capable of adhering to the treatment plan related to this ROSY-S study.
Exclusion criteria
* Participant develops hypersensitivity to any of the components of anifrolumab. * Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study. * Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent study for anifrolumab) whichever is longer. * Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting anifrolumab. * Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF. * Participants who are planning to use live/live-attenuated vaccines. * Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program as determined by the Investigator. * Participants with any medical condition (such as cancer or viral infections \[hepatitis\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments. * Participants who discontinued the parent study prior to completion of all study visits. * Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAEs and Non-Serious AEs | From first dose administered and until 12 weeks after the last dose of Anifrolumab | 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 |
Countries
Austria, Belgium, Brazil, Bulgaria, France, Greece, India, Israel, Italy, Japan, Philippines, Poland, Romania, Serbia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed