NCT06673043

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
27mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Feb 2025Jun 2028

First Submitted

Initial submission to the registry

October 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

October 30, 2024

Last Update Submit

April 10, 2026

Conditions

Lupus Erythematosus, Systemic

Keywords

Anifrolumabsystemic lupus erythematosusSLEobservational

Outcome Measures

Primary Outcomes (1)

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

    at month 12

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

SLE Patients

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

Drug: Anifrolumab

Interventions

AnifrolumabDRUG

Anifrolumab 300 mg concentrate for solution for infusion

Also known as: Saphnelo
SLE Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive adult (aged ≥18 year old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Bydgoszcz, Poland

RECRUITING

Research Site

Bytom, Poland

RECRUITING

Research Site

Gdansk, Poland

RECRUITING

Research Site

Katowice, Poland

RECRUITING

Research Site

Krakow, Poland

RECRUITING

Research Site

Lodz, Poland

RECRUITING

Research Site

Lublin, Poland

RECRUITING

Research Site

Poznan, Poland

RECRUITING

Research Site

Rzeszów, Poland

RECRUITING

Research Site

Warsaw, Poland

RECRUITING

Research Site

Wroclaw, Poland

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

anifrolumab

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 4, 2024

Study Start

February 28, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Time Frame
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.
Access Criteria
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
More information

Locations

PL(11)