1) neuropsychiatric SLE (NPSLE), 2) severe or refractory lupus nephritis (LN), 3) interstitial lung diseases complicated with dermatomyositis (DM-ILD)
Conditions
Interventions
None listed
Sponsors
Hokkaido University Hospital Internal Medicine II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as NPSLE, severe LN, or DM-ILD according to the Japanese diagnostic criteria 2) In addition to corticosteroids (CS), at least 1 (dual treatment group) or one (single treatment group) of the following immunosuppressants are administrated: cyclphosphamide (CY), tacrolimus (TAC), micophanolate motetil (MMF), azathioprine (AZP), mizoribine (MZR), methotrexate (MTX), cyclosporin (CsA), hydroxychroloquine (HCQ) 3) For severe LN, to fulfill the following (1) or (2), for DM-ILD, one of the following (2)m (3), or (4) (1) ISN/RPS classification: III, IV, V, III + V, or IV +V (2) Resistant or refractory to CS or CS + one immunosuppressant (3) Anti-MDA5 antibody positive (4) Acute progression 4) Those who agreed with participating to the present study
Exclusion criteria
Exclusion criteria: 1) Participation to clinical trials for other drugs within 12 wks before obtaining agreement 2) Those who received biologics, cell-depleting therapy such as rituximab, stem cell transplantation 3) Those with active infection 4) Those who were considered as inappropriate by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRI [SLE responder index] for NPSLE and severe LN, respiratory function (%VC, %DLCO) for DM-ILD at 3, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Adverse events 2) Patient survival 3) HAQ 4) SELENA-SLEDAI, PhGA, BILAG (NPSLE and severe LN) 5) Urinary protein (g/gCr) (severe LN) 6) CT findings, SpO2, P/F ratio (DM-ILD) 7) Accumulative dose of corticosteroids | — |
Countries
Japan
Contacts
Public ContactShinsuke Yasuda
Hokkaido University Hospital Internal Medicine II
Outcome results
None listed