systemic lupus erythematosus, systemic lupus erythematosus, SLE
Conditions
Interventions
Anifrolumab 300 mg will be intravenously administered every 4weeks for 24 weeks.
Sponsors
Kono Michihito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who are at least 18 years and less than 60 years of age at the time of consent 2)Patients who have received a comprehensive explanation of their participation in this study and who have given their free and informed consent 3)Patients with < 43 points of fatigue scale (FACIT-F) for SLE within 28 days prior to enrollment (the same day of the week as the enrollment date is acceptable) 4)Patients who underwent fMRI evaluation within 28 days prior to enrollment 5)Patients who fulfilled the American College of Rheumatology classification criteria for SLE (revised in 1997) at the time of diagnosis 6)Patients who are scheduled to receive anifrolumab according to health insurance coverage
Exclusion criteria
Exclusion criteria: 1)SLE patients with severe organ complications including active (BILAG category A or B) neuro-psychiatric SLE (NPSLE) or lupus nephritis 2)Patients with other collagen diseases such as myositis and fibromyalgia. However, patients with Sjogrens syndrome may be enrolled. 3)Patients currently receiving treatment with anifrolumab or prohibited concomitant drugs and prohibited concomitant therapies. However, patients may be enrolled if the following days have passed since the last administration. -Anifrolumab : >= 90 days -Other anti-BAFF antibodies, including belimumab : >= 90 days -JAK inhibitors (tofacitinib, baricitinib, etc.) : >= 90 days -High-dose immunoglobulin therapy (IVIG), plasma exchange : >= 90 days -CD20 antibodies, including rituximab : >= 180 days -Live vaccines, cyclophosphamide : >= 30 days 4)Pregnant women, lactating women, or women who wish to pregnant during the study period. 5)Persons with strong suspicion of organic brain disease 6)Patients with serious physical diseases (heart, liver, kidney) 7)Patients with severe anemia (Hb < 7.0 g/dL) in the most recent test before enrollment 8)Those for whom MRI imaging is contraindicated or difficult to perform 9)Patients with active hepatitis B or active tuberculosis. However, the activity is determined by the investigator 10)Patients participating in clinical trials or prospective clinical studies 11)Other patients deemed inappropriate as study subjects by the site principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in functional connectivity (FC) measured by fMRI from baseline to 12 weeks after anifrolumab administration | — |
Secondary
| Measure | Time frame |
|---|---|
| i)Change in fatigue scale (FACIT-F, CFS) before, 12 weeks after and 24 weeks after anifrolumab administration ii)Correlation between changes in FC and changes in fatigue scales (FACIT-F, CFS) before, 12 weeks after and 24 weeks after anifrolumab administration iii)Change in plasma protein levels in serum before and 24 weeks after anifrolumab administration iv)Change in disease activity before, 12 weeks after and 24 weeks after anifrolumab administration v)Improvement rate of fatigue scale and disease activity after administration of anifrolumab vi)Safety | — |
Contacts
Public ContactYuichiro Fujieda
Hokkaido University Hospital
Outcome results
None listed