INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus (SLE). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina, China, Costa Rica, Egypt, Guatemala +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Overview
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.
Detailed description
INTERSTELLAR is a multi-country, single-arm, observational, cohort study, with 1 year retrospective baseline data and 1 year of prospective follow-up. The study will be initiated on a country-by-country basis following the commercial launch of anifrolumab. The enrolment period is anticipated to be 12 months per country. In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Relevant clinical and patient reported outcome (PRO) data collection for the entire follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study
Primary outcome measures
- PGA [Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
- SLEDAI-2K [Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
- CLASI [Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
- FACIT-Fatigue [Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12]
- LupusQoL [Time frame: Baseline (pre-infusion) Month 3, Month 6, Month 12]
- EQ-5D-5L [Time frame: Baseline (pre-infusion) Month 3, Month 6, Month 12]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Kazakhstan · 8 centers
- Research Site — Aktobe
- Research Site — Almaty
- Research Site — Almaty
- Research Site — Astana
- Research Site — Astana
- Research Site — Pavlodar
- Research Site — Semey
- Research Site — Shymkent
China · 5 centers
- Research Site — Guangzhou
- Research Site — Hong Kong
- Research Site — Shenzhen
- Research Site — Zhongshan
- Research Site — Zhuhai
Taiwan · 5 centers
- Research Site — Kaohsiung City
- Research Site — Taichung
- Research Site — Taichung
- Research Site — Taipei
- Research Site — Taoyuan
Saudi Arabia · 3 centers
- Research Site — ASIR
- Research Site — Jeddah
- Research Site — Riyadh
Argentina · 2 centers
- Research Site — Buenos Aires
- Research Site — Córdoba
Egypt · 2 centers
- Research Site — Alexandria
- Research Site — Cairo
Mexico · 2 centers
- Research Site — Mexico City
- Research Site — Mérida
Costa Rica · 1 center
- Research Site — San José
Guatemala · 1 center
- Research Site — Guatemala City
Kuwait · 1 center
- Research Site — Kuwait City
Oman · 1 center
- Research Site — Muscat
Qatar · 1 center
- Research Site — Doha
Identifiers
NCT: NCT06314282 · D3461R00072