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Clinical Trials/NCT06673043
NCT06673043Active, not recruitingNot Applicable

Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study

AstraZeneca13 sites in 1 country105 target enrollmentStarted: February 28, 2025Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
105
Locations
13
Primary Endpoint
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
  • •Patients willing to participate in the study and signed Informed Consent Form (ICF).

Exclusion Criteria

  • •Those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through NDP.
  • •Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Arms & Interventions

SLE Patients

Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland.

Intervention: Anifrolumab (Drug)

Outcomes

Primary Outcomes

Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

Time Frame: at month 12

Secondary Outcomes

  • 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;)
  • Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)(at month 6, 12, 18, 24;)
  • Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)(at month 6, 12, 18, 24)
  • Proportion of patients achieving the composite endpoint of remission(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(very 6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (13)

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