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The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.
This is multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with SLE that received anifrolumab in the scope of routine clinical practice within the frames of National Drug Program (NDP) for up to 30 months (~ 6 months baseline and ~24 months follow-up date).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLE Patients | Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anifrolumab | Drug | Anifrolumab 300 mg concentrate for solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score | at month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score | at month 6, 18, 24; | |
| Change from index date in Physician Global Assessment (PGA) score | at month 6, 12, 18, 24; |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive adult (aged ≥18 year old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bydgoszcz | Poland | ||||
| 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: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582345 | anifrolumab |
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| Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI) | mSRI defined as: a reduction in SLEDAI-2K ≥4 points with no worsening in PGA ≥0.3 points | at month 6, 12, 18, 24; |
| Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS) | LLDAS defined as: SLEDAI-2K ≤4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with previous assessment; PGA ≤1; current prednisone(-equivalent) dose ≤7.5mg/day; well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any. | at month 6, 12, 18, 24 |
| Proportion of patients achieving the composite endpoint of remission | Disease activity index (cSLEDAI)=0, PGA <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics. | at month 6, 12, 18,24 |
| Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids | every 6 months |
| Change from index date in corticosteroids dose | at month 6, 12, 18, 24 |
| Proportion of steroid-free patients at every 6 months | every 6 months |
| Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24 | at month 6, 12, 18, 24 |
| Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction | at month 6, 12, 18, 24 |
| Anifrolumab treatment adherence | Comparison of actual and expected number of infusions (%) evaluate | very 6 months |
| Bytom |
| Poland |
| Research Site | Gdansk | Poland |
| Research Site | Katowice | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Lublin | Poland |
| Research Site | Poznan | Poland |
| Research Site | Rzeszów | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |