臨床研究等提出・公開システム

Anifrolumab for Lupus Fatigue: Functional MRI Application in SLE (ALFA-SLE)

ALFA-SLE (ALFA-SLE)

Kono Michihito

Hokkaido University Faculty of Medicine and Graduate School of Medicine

Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan

m-kono@med.hokudai.ac.jp

Fujieda Yuichiro

Hokkaido University Hospital

Kita 15 Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan

+81-11-706-5915

yfujieda@keio.jp

Recruiting

June. 03, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

systemic lupus erythematosus,

Anifrolumab 300 mg will be intravenously administered every 4weeks for 24 weeks.

systemic lupus erythematosus, SLE

Changes in functional connectivity (FC) measured by fMRI from baseline to 12 weeks after anifrolumab administration

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

+81-11-706-7934

Mar. 24, 2026

none