Clinical trial NCT06314282: INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
Official title: INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: SLE
Systemic lupus erythematosus
autoimmune disease
Lupus
Anifrolumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older at study enrolment.
2. Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry.
3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.
4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.
5. 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.
6. Provided informed consent to participate in the study.
7. Willing and able to participate in all required study evaluations and procedures.

Exclusion Criteria:

1. Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product.
2. Previous exposure to anifrolumab as part of a clinical trial or early access program.
3. 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.
4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.

Primary outcomes:
measure: PGA
timeFrame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
measure: SLEDAI-2K
timeFrame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
measure: CLASI
timeFrame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
measure: FACIT-Fatigue
timeFrame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
measure: LupusQoL
timeFrame: Baseline (pre-infusion) Month 3, Month 6, Month 12
measure: EQ-5D-5L
timeFrame: Baseline (pre-infusion) Month 3, Month 6, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Zhongshan
country: China
facility: Research Site
city: Doha
country: Qatar
facility: Research Site
city: Abha
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
Study officials:
References: