Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis

JRCT ID: jRCTs031180370

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Systemic sclerosis
• Date of first enrollment: 12/11/2013
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Administrate 8 mg/kg of tocilizumab once every four weeks for six months

Outcome(s)

• Primary Outcome: modified Rodnan total skin score
• Secondary Outcome: Thickness of skin pathological tissue, Adverse events

Key inclusion & exclusion criteria

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

Include 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

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)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

Related Information

• Primary Sponsor: Yoshizaki Ayumi
• Secondary Sponsor: Sato Shinichi
• Secondary ID(s): UMIN000012214