Interstitial lung disease secondary to systemic sclerosis
Conditions
Interventions
Rituximab(+) 30weeks 375mg/m2 once a week 4 times
Sponsors
Department of Dermatology, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)interstitial lung disease secondary to systemic sclerosis 2)resistance to standard treatment (oral prednisolone + cyclophosphamide pulse) 3)untreatable with cyclophosphamide pulse because of advers effects 4)no desired effect of cyclophosphamide pulse on interstitial lung disease from the results of SP-D, KL-6 and clinical course 5)no malignancy 6)from 20 years old to 80 years old 7)obtaining informed consent
Exclusion criteria
Exclusion criteria: 1)during treatment with equal drug 2)previous history of anaphylactic reactions to this drug 3)significant infection 4)significant liver damage 5)significant renal damage 6)less than or equal to 60% of %VC or 40% of %DLco 7)previous history of significant infection 8)pregnancy 9)breast-feeding 10)participating in other clinical trial within three months before the beginning of this trial 11)judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function test | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of interstitial lung disease progression on CT Serum levels of KL-6 and SP-D Assessment of Safety | — |
Countries
Japan
Contacts
Public ContactAyumi Yoshizaki
The University of Tokyo Department of Dermatology
Outcome results
None listed