Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis

JRCT ID: jRCTs031180373

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Interstitial lung disease secondary to systemic sclerosis
• Date of first enrollment: 14/05/2012
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Rituximab 375mg/m2 once a week/4 times

Outcome(s)

• Primary Outcome: Lung function test
• Secondary Outcome: Assessment of interstitial lung disease progression on CT, Serum levels of KL-6 and SP-D, Assessment of Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

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

Exclude 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

Related Information

• Primary Sponsor: Yoshizaki Ayumi
• Secondary Sponsor: Sato Shinichi
• Source(s) of Monetary Support: Health and Labour Sciences Research Grants for research on intractable diseases/ Scleroderma Research Group
• Secondary ID(s): UMIN000007702