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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anifrolumab | Experimental | This is a single arm open-label study with the primary objective of providing continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment and assessing long-term safety and tolerability of anifrolumab until participant meets one of the study discontinuation criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anifrolumab | Combination Product | Anifrolumab pre-filled syringe |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From first dose administered and until 12 weeks after the last dose of Anifrolumab |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | +1877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90045 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment. "Yes" indicates that AstraZeneca is accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability commitments in line with EFPIA/PhRMA Data Sharing Principles. For details of timelines, refer to AstraZeneca's disclosure commitment.
When a request has been approved, AstraZeneca will provide access to anonymized individual patient-level data via a secure research environment (Vivli). A signed Data Usage Agreement must be in place before accessing the data.
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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.
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| Anifrolumab |
| Combination Product |
Anifrolumab solution for injection in pre-filled pen |
|
| Anifrolumab | Drug | Anifrolumab concentrate for solution for infusion |
|
| Fort Lauderdale |
| Florida |
| 33309 |
| United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Graz | 8010 | Austria |
| Research Site | Graz | 8036 | Austria |
| Research Site | Ghent | 9000 | Belgium |
| Research Site | Salvador | 40150-150 | Brazil |
| Research Site | Sofia | 1618 | Bulgaria |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Strasbourg | 67200 | France |
| Research Site | Toulouse | 31300 | France |
| Research Site | Chaïdári | 124 62 | Greece |
| Research Site | Kolkata | 700020 | India |
| Research Site | Haifa | 31048 | Israel |
| Research Site | Milan | 20122 | Italy |
| Research Site | Sapporo | 060-8648 | Japan |
| Research Site | Iloilo City | 5000 | Philippines |
| Research Site | Lipa City | 4217 | Philippines |
| Research Site | Bydgoszcz | 85-168 | Poland |
| Research Site | Kielce | 25-316 | Poland |
| Research Site | Krakow | 30-040 | Poland |
| Research Site | Iași | 700661 | Romania |
| Research Site | Kragujevac | 34000 | Serbia |
| Research Site | Piešťany | 92101 | Slovakia |
| Research Site | Seoul | 6591 | South Korea |
| Research Site | Barcelona | 8041 | Spain |
| Research Site | Granada | 18014 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Valencia | 46014 | Spain |
| Research Site | Kaohsiung City | 83301 | Taiwan |
| Research Site | Taichung | 404327 | Taiwan |
| Research Site | Bangkok | 10700 | Thailand |
| Research Site | Khon Kaen | 40002 | Thailand |
| Research Site | Fatih-Istanbul | 34098 | Turkey (Türkiye) |
| Research Site | London | SE5 9RS | United Kingdom |
| Research Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Research Site | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| C582345 | anifrolumab |
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