Systemic sclerosis
Conditions
Interventions
Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1)Patients who are administered the other biologics 2)Patients who have history of anaphylactic reactions to this drug 3)Patients who have HBV or who are under the septic condition 4)significant liver damage 5)significant renal damage 6)possibility of tuberculosis 7)pregnancy 8)breast-feeding 9)participating in other clinical trial within three months before the beginni ng of this trial 10)judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of skin scores from 17 sites of the body (modified Rodnan total skin score) | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin hardness, elasticity, and viscosity evaluate by Vesmter | — |
Countries
Japan
Contacts
Public ContactYoshihito Shima
Osaka University Allergy and Rheumatic Diseases
Outcome results
None listed