Systemic sclerosis
Conditions
Sponsors
Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Rheumatology Keio University, Rheumatology Tokyo Women'
s Medical University, Dermatology Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Nonpregnant adult agreeded to contraception if female 2) Patients with diffuse cutaneous systemic sclerosis fulfilled ACR criteria 3) Over 16 skin score with skin sclerosis on fingers, dorsal hands, forearms, and upper arms; change of total skin score is within 10% during the screening period (two months) 4) Patients who are able to give consent in writing after reading the explanatory text
Exclusion criteria
Exclusion criteria: 1) A patient who fit the careful administration criteria in the package insert of tocilizumab, except for interstitial pneumonitis 2) A patient who has applied a drug trial within six months 3) A patient who are using cyclophosphamide or has received intravenous cyclophosphamide infusion 4) A patient who are receiving or has received biologics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of 17 areas skin score estimated by attandings | — |
Secondary
| Measure | Time frame |
|---|---|
| Sum of 17 areas z-score evaluated with Vesmeter, Range of joint mortions(ROM) and self-grading HAQ | — |
Countries
Japan
Contacts
Public ContactYoshihito Shima
Osaka University Graduate School of Medicine Respiratory Medicine, Allergy and Rheumatic Diseases
Outcome results
None listed