Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
SLE, Systemic lupus erythematosus, autoimmune disease, Lupus, Anifrolumab
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follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PGA | Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12 | Physician's overall assessment of disease activity on a visual analog scale ranging from 0 (no activity) to 3 (severe activity). |
| SLEDAI-2K | Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12 | 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. |
| CLASI | Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12 | 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. |
| FACIT-Fatigue | Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12 | 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 |
| LupusQoL | Baseline (pre-infusion) Month 3, Month 6, Month 12 | A 34-item questionnaire on a verbal rating scale covering several domains, including daily activities, pain, fatigue and sleep in relation to lupus symptoms. |
| EQ-5D-5L | Baseline (pre-infusion) Month 3, Month 6, Month 12 | 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 |
Countries
Argentina, China, Costa Rica, Egypt, Guatemala, Kazakhstan, Kuwait, Mexico, Oman, Qatar, Saudi Arabia, Taiwan
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed