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

Yoshizaki Ayumi0 个研究点目标入组 33 人开始时间: 2019年3月18日最近更新: 2023年10月17日

适应症

试验速览

Rituximab may improve systemic sclerosis-associated interstitial pneumonia in a relatively safe manner.

•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

发起方

Yoshizaki Ayumi