INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

Status: Recruiting
Location: See all (15) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Argentina
Research Site
RECRUITING
Buenos Aires
Research Site
RECRUITING
Córdoba
China
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
RECRUITING
Shenzhen
Research Site
RECRUITING
Zhongshan
Oman
Research Site
RECRUITING
Muscat
Qatar
Research Site
RECRUITING
Doha
Saudi Arabia
Research Site
RECRUITING
Abhā
Research Site
RECRUITING
Jeddah
Research Site
RECRUITING
Riyadh
Taiwan
Research Site
RECRUITING
Kaosiung
Research Site
RECRUITING
New Taipei City
Research Site
RECRUITING
Taichung
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
RECRUITING
Taipei
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov