Tocilizumab long-term extension trial in patients with adult onset still
- Conditions
- Adult onset still disease
- Registration Number
- JPRN-UMIN000018414
- Lead Sponsor
- Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 34
Not provided
1) Patients who have not been enrolled within 3 months since last observation in KCCR-D002 clinical trial 2)Patients having received following therapy before starting treatment since last observation in KCCR-D002 clinical trial (1) Tocilizumab , Inflixmab, Golimumab, Adalimumab, Apatacept, Leflunomide Certolizumab pegol,Etanercept and these biosimilar (2) DMARDs or immune-suppressing drug (3) Cell depletion therapy (4) Surgical treatment excluding local procedures (dental extraction or ophthalmologic laser surgery etc. (5) Plasma exchange therapy (6) Tocilizumab 3) Patients with serious drug allergy for Tocilizumab in KCCR-D002 clinical trials 4) Patient with current and past history of following disease and diagnosed as inapplicable to this study by a doctor, cardiovascular disease, hematologic/ hematopoietic disease, respiratory disease, neurological/muscular disorder, endocrine disease, renal/urological disease or gastroenterological disorder 5) Patients with infection within 4 weeks before initial administration in this study and diagnosed as inapplicable to this study by a doctor 6) Expectant mother, mother with breast-feeding, patient who have possibility of pregnancy or hope to be pregnant 7) Others not applicable person determined by a doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Safety> Onset frequency of Adverse even and side effect <Efficacy> Changes of proportion of patient discontinued corticosteroid Changes of ACR 20%, 50% and 70% improvement criteria Change of ACR core set
- Secondary Outcome Measures
Name Time Method