Tocilizumab LTE study in patients with SSc
Phase 3
Completed
- Conditions
- Systemic sclerosis
- Registration Number
- JPRN-jRCT2080223704
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
(1) Patients who participated in WA29767 study and finished assessments scheduled at Week 96
Exclusion Criteria
(1) Evidence of moderately severe pulmonary (e.g., asthma and emphysema), cardiovascular, hepatic, nervous system, renal, endocrine, or gastrointestinal disease not related to SSc as determined by the investigator at study entry
(2) Known active current bacterial, viral, fungal, mycobacterial, or other recurrent infections (e.g., atopical mycobacterial disease, hepatitis B or C, herpes zoster, infected digital ulcers, and osteomyelitis) at study entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacodynamics<br>Safety: adverse event, laboratory value, vital sign<br>Efficacy: change in mRSS, FVC, J-HAQ<br>Pharmacodynamics: change in PD biomarker concentration (IL-6, sIL-6R, CRP, ESR)
- Secondary Outcome Measures
Name Time Method