Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis
- Conditions
- Interstitial lung disease secondary to systemic sclerosis
- Registration Number
- JPRN-jRCTs031180373
- Lead Sponsor
- Yoshizaki Ayumi
- Brief Summary
Rituximab may improve systemic sclerosis-associated interstitial pneumonia in a relatively safe manner.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 33
Patient who meets under all of the following 1)~5)
1) interstitial lung disease secondary to systemic sclerosis
2) no malignancy
3) from 20 years old to 80 years old no desired effect of cyclophosphamide pulse on interstitial lung disease from the results of SP-D, KL-6 and clinical course
4) obtaining informed consent
5) patient who meets under any of the following (a)~ (c)
(a) resistance to standard treatment (oral prednisolone + cyclophosphamide pulse)
(b) untreatable with cyclophosphamide pulse because of adverse effects
(c) no desired effect of cyclophosphamide pulse on interstitial lung disease from the results of SP-D, KL-6 and clinical course
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ung function test
- Secondary Outcome Measures
Name Time Method Assessment of interstitial lung disease progression on CT, Serum levels of KL-6 and SP-D, Assessment of Safety