INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use

NCT06314282 | Recruiting

• 1 other identifier: D3461R00072
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

SLE; Systemic lupus erythematosus; autoimmune disease; Lupus; Anifrolumab

Outcome Measures

Primary Outcomes (6)

• PGA

  Physician's overall assessment of disease activity on a visual analog scale ranging from 0 (no activity) to 3 (severe activity).

  Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12

• SLEDAI-2K

  24 lupus-related (weighted) items to assess disease activity, rated as 'present' or 'absent' and attributed to active lupus. Scored on a scale from 0 to 105, with 0 being inactive disease.

  Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12

• CLASI

  Skin activity and damage assessment completed by physician by scoring each specific area as indicated on the form. The higher the score, the worse the activity/damage.

  Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12

• FACIT-Fatigue

  A 13-item questionnaire to assess the impact of fatigue on a 5-point verbal rating scale. Scores range from 0 to 52; a higher score indicates les fatigue

  Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12

• LupusQoL

  A 34-item questionnaire on a verbal rating scale covering several domains, including daily activities, pain, fatigue and sleep in relation to lupus symptoms.

  Baseline (pre-infusion) Month 3, Month 6, Month 12

• EQ-5D-5L

  5-item questionnaire measuring 5 dimensions of general health status on a verbal rating, and a single visual analog scale about overall perceived health today

  Baseline (pre-infusion) Month 3, Month 6, Month 12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 to 50 patients will be enrolled per country from academic, community and hospital outpatient settings, to maximize the representation of the study population. This will result in approximately 180-200 patients in total allowing for sufficient precision when analysing the total cohort and to explore subgroups of interest.

You may qualify if:

• Aged 18 years or older at study enrolment.
• Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry.
• Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.
• It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.
• In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.
• Provided informed consent to participate in the study.
• Willing and able to participate in all required study evaluations and procedures.

You may not qualify if:

• Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product.
• Previous exposure to anifrolumab as part of a clinical trial or early access program.
• Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide \[CYC\] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.
• Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Aktobe, Kazakhstan

RECRUITING

Research Site

Almaty, Kazakhstan

RECRUITING

Research Site

Astana, Kazakhstan

RECRUITING

Research Site

Pavlodar, Kazakhstan

RECRUITING

Research Site

Semey, Kazakhstan

RECRUITING

Research Site

Shymkent, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.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: March 11, 2024
• First Posted: March 18, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

KA (6)