Adult onset still disease
Conditions
Interventions
Tocilizumab
Sponsors
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who completed KCCR-D002 clinical trial 2)Patients in KCCR-D002 clinical trial in who were identified adequate safety by doctors 3)Patients identified as required Tocilizumab long-term extension by a doctor 4)Patients requesting continuous administration of Tocilizumab, whose written informed consent has been obtained
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| <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 | — |
Countries
Japan
Contacts
Public ContactYuto Fujiki
Keio University Hospital Clinical and Translational Research Center
Outcome results
None listed