Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis
- Conditions
- Systemic sclerosis
- Registration Number
- JPRN-UMIN000005550
- Lead Sponsor
- Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
- Brief Summary
To explore the influence of the anti-interleukin-6 receptor antibody tocilizumab (TCZ) on patients with systemic sclerosis, we conducted a parallel group comparison study in three hospitals. At the end of 6 months, the average change in mRSS was larger in the TCZ group (6.3) than in the Conv group (3.4), but the difference was not statistically significant because of high variance in the TCZ group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sum of 17 areas skin score estimated by attandings
- Secondary Outcome Measures
Name Time Method Sum of 17 areas z-score evaluated with Vesmeter, Range of joint mortions(ROM) and self-grading HAQ