systemic lupus erythematosus
Conditions
Interventions
None listed
Sponsors
University of Occupational and Environmental Health, Japan
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient diagnosed with SLE based on the 1997 ACR Classification Criteria, or 2012 SLICC Classification Criteria, or 2019 ACR/EULAR Classification Criteria. 2. Patient aged 16 years or older at the time of informed consent with the written document. 3. Patient from whom the consent can be obtained with the written document for the participation of the study. However, for the patient aged 16 or older but under 18, consent with the written document should also be obtained from his/her legal representative. 4. Patient who received a sufficient explanation, has a will to observe, and can also observe the content of explanation provided.
Exclusion criteria
Exclusion criteria: 1. Patient who has a history of receiving any of following treatments for a predetermined period prior to the baseline examination. -Steroid pulse therapy (within 1 month) -Oral formulation of immunosuppressants (within 3 months) Cyclophosphamide, cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, mycophenolate mofetil, methotrexate, mizoribine -Intravenous administration of immunosuppressants (within 6 months) -Biological product (within 12 months) Belimumab -Other unapproved treatments for SLE (within 12 months) Rituximab, study drug, etc. for SLE -Cytapheresis (within 12 months) 2.Patient diagnosed with collagen disease other than SLE and who has experienced the therapeutic intervention (including non-drug treatment) in the past. 3.Patient who is positive in any of following viral tests at screening period or within 3 months prior to baseline (including the period prior to consent for this study). -Human immunodeficiency virus (HIV) -Hepatitis B surface antigen (HBs antigen) -Hepatitis B surface antibody (HBs antibody) However, if it is clearly due to hepatitis B vaccination, and HBs antibody alone is positive and hepatitis B virus DNA (HBV-DNA) assay is negative, participation is allowed. -Hepatitis B virus core antibody (HBc antibody) -Hepatitis C virus antibody (HCV antibody) -Human T-cell leukemia virus type-1 antibody (HTLV-1 antibody) 4.Other patients considered as not appropriate for participation of the study by investigator (or subinvestigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease activity index (SELENA SLEDAI, BILAG, PGA), SLICC Damage index, PRO (EQ-5D-5L, Lupus-PRO), Laboratory test, Blood cytokine test and Biomarker test. | — |
Countries
Japan
Contacts
Public ContactJunji Takahashi
MEDISCIENCE PLANNING INC. Clinical Development Division
Outcome results
None listed