SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)
Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05141201
Collaborator
(none)
600
94
47.3
6.4
0.1
Study Details
Study Description
Brief Summary
To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The objective of the Specific Use Result Study is to collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus insufficiently responding to currently available treatment in the real-world post-marketing setting.
This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Saphnelo for Intravenous Infusion 300 mg Specific Use Result Study All Patient Investigation in Patients With Systemic Lupus Erythematosus
Actual Study Start Date
:
Dec 21, 2021
Anticipated Primary Completion Date
:
Nov 30, 2025
Anticipated Study Completion Date
:
Nov 30, 2025
Outcome Measures
Primary Outcome Measures
- Incidence of ADRs [from the baseline to 52 weeks]
Incidence of ADRs related to Anifrolimab. Safety specification: Herpes zoster, serious infections, anaphylaxis, malignancy and reactivation of hepatitis B virus
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
patients with systemic lupus erythematosus insufficiently responding to currently available treatment -
Exclusion Criteria:
None
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Aichi | Japan | ||
| 2 | Research Site | Aichi | Japan | ||
| 3 | Research Site | Akita | Japan | ||
| 4 | Research Site | Akita | Japan | ||
| 5 | Research Site | Aomori | Japan | ||
| 6 | Research Site | Chiba | Japan | ||
| 7 | Research Site | Chiba | Japan | ||
| 8 | Research Site | Chiba | Japan | ||
| 9 | Research Site | Ehime | Japan | ||
| 10 | Research Site | Ehime | Japan | ||
| 11 | Research Site | Fukui | Japan | ||
| 12 | Research Site | Fukuoka | Japan | ||
| 13 | Research Site | Fukuoka | Japan | ||
| 14 | Research Site | Fukushima | Japan | ||
| 15 | Research Site | Fukushima | Japan | ||
| 16 | Research Site | Gifu | Japan | ||
| 17 | Research Site | Gifu | Japan | ||
| 18 | Research Site | Gifu | Japan | ||
| 19 | Research Site | Gunma | Japan | ||
| 20 | Research Site | Gunma | Japan | ||
| 21 | Research Site | Gunma | Japan | ||
| 22 | Research Site | Hiroshima | Japan | ||
| 23 | Research Site | Hiroshima | Japan | ||
| 24 | Research Site | Hokkaido | Japan | ||
| 25 | Research Site | Hokkaido | Japan | ||
| 26 | Research Site | Hokkaido | Japan | ||
| 27 | Research Site | Hokkaido | Japan | ||
| 28 | Research Site | Hyogo | Japan | ||
| 29 | Research Site | Hyogo | Japan | ||
| 30 | Research Site | Ibaraki | Japan | ||
| 31 | Research Site | Ibaraki | Japan | ||
| 32 | Research Site | Ishikawa | Japan | ||
| 33 | Research Site | Ishikawa | Japan | ||
| 34 | Research Site | Ishikawa | Japan | ||
| 35 | Research Site | Iwate | Japan | ||
| 36 | Research Site | Iwate | Japan | ||
| 37 | Research Site | Kagawa | Japan | ||
| 38 | Research Site | Kagawa | Japan | ||
| 39 | Research Site | Kagoshima | Japan | ||
| 40 | Research Site | Kanagawa | Japan | ||
| 41 | Research Site | Kanagawa | Japan | ||
| 42 | Research Site | Kanagawa | Japan | ||
| 43 | Research Site | Kochi | Japan | ||
| 44 | Research Site | Kumamoto | Japan | ||
| 45 | Research Site | Kumamoto | Japan | ||
| 46 | Research Site | Kyoto | Japan | ||
| 47 | Research Site | Kyoto | Japan | ||
| 48 | Research Site | Mie | Japan | ||
| 49 | Research Site | Mie | Japan | ||
| 50 | Research Site | Mie | Japan | ||
| 51 | Research Site | Miyagi | Japan | ||
| 52 | Research Site | Miyazaki | Japan | ||
| 53 | Research Site | Miyazaki | Japan | ||
| 54 | Research Site | Nagano | Japan | ||
| 55 | Research Site | Nagano | Japan | ||
| 56 | Research Site | Nagasaki | Japan | ||
| 57 | Research Site | Nagasaki | Japan | ||
| 58 | Research Site | Nara | Japan | ||
| 59 | Research Site | Niigata | Japan | ||
| 60 | Research Site | Niigata | Japan | ||
| 61 | Research Site | Oita | Japan | ||
| 62 | Research Site | Oita | Japan | ||
| 63 | Research Site | Okayama | Japan | ||
| 64 | Research Site | Okinawa | Japan | ||
| 65 | Research Site | Osaka | Japan | ||
| 66 | Research Site | Osaka | Japan | ||
| 67 | Research Site | Saga | Japan | ||
| 68 | Research Site | Saga | Japan | ||
| 69 | Research Site | Saitama | Japan | ||
| 70 | Research Site | Saitama | Japan | ||
| 71 | Research Site | Shiga | Japan | ||
| 72 | Research Site | Shiga | Japan | ||
| 73 | Research Site | Shimane | Japan | ||
| 74 | Research Site | Shizuoka | Japan | ||
| 75 | Research Site | Shizuoka | Japan | ||
| 76 | Research Site | Tochigi | Japan | ||
| 77 | Research Site | Tochigi | Japan | ||
| 78 | Research Site | Tochigi | Japan | ||
| 79 | Research Site | Tokushima | Japan | ||
| 80 | Research Site | Tokyo | Japan | ||
| 81 | Research Site | Tokyo | Japan | ||
| 82 | Research Site | Tokyo | Japan | ||
| 83 | Research Site | Tokyo | Japan | ||
| 84 | Research Site | Tokyo | Japan | ||
| 85 | Research Site | Tottori | Japan | ||
| 86 | Research Site | Tottori | Japan | ||
| 87 | Research Site | Toyama | Japan | ||
| 88 | Research Site | Toyama | Japan | ||
| 89 | Research Site | Wakayama | Japan | ||
| 90 | Research Site | Yamagata | Japan | ||
| 91 | Research Site | Yamagata | Japan | ||
| 92 | Research Site | Yamaguchi | Japan | ||
| 93 | Research Site | Yamaguchi | Japan | ||
| 94 | Research Site | Yamanashi | Japan |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT05141201
Other Study ID Numbers:
- D3461C00022
First Posted:
Dec 2, 2021
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms: