Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis

Phase 2

• Conditions: Systemic sclerosis

• Registration Number: JPRN-jRCTs031180370
• Lead Sponsor: Yoshizaki Ayumi

Brief Summary

This study suggested that tocilizumab may improve skin sclerosis in systemic sclerosis safely.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study Completion: 2019-07-30
• Results First Posted: 2021-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1)Patients with systemic sclerosis with sever skin sclerosis
2)Over 6 modified Rodnan total skin score with skin sclerosis on fingers, dorsal hands, forearms, and upper arms; change of total skin score is within 20% during the screening period (two months)
3)no malignancy
4)from 20 years old to 80 years old
5)Agreement to contraception during the study period
6)Patients who are able to give consent in writing after reading the explanatory text

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)pregnancy
7)breast-feeding
8)participating in other clinical trial within three months before the beginning of this trial
9)judged inappropriate for this study by the physicians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rodnan total skin score

Secondary Outcome Measures

Name	Time	Method
Thickness of skin pathological tissue, Adverse events