Adult onset still diseas
Conditions
Interventions
Sponsors
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with adult onset still disease diagnosed according to classification criteria by Yamaguchi(1992) 2) Patients aged 20 or older 3) Patients diagnosed over 16 years old 4) Patients whose response to over 0.5mg/kg/day corticosteroid are insufficient, and who have received more than 10mg/day corticosteroid over 2 weeks before participating in this trial 5) Numbers of tender and swollen joints are 2 or more, and Patient with over 1 point in SFS 6) ESR(Westergren) =>20 mm/hr or CRP =>10 mg/L 7) Patients whose written informed consent has been obtained
Exclusion criteria
Exclusion criteria: 1) Patients having received Inflixmab, Golimumab, Adalimumab, Apatacept, Leflunomide and Certolizumab pegol within 12 weeks 2) Patients having received Etanercept within weeks before starting treatment 3) Patients having received surgical treatment or plasmapheresis within 4 weeks before starting treatment 4) Patients having received DMARDs or immune-suppressing drug within 2 weeks 5) Patients having changing the dose of corticosteroid within 2 weeks 6) Patients having received cell depletion therapy before participation in this study 7) White blood cell count <3x10^9/L 8) Neutrophil count <1,000/microliter 9) Platelet count <50x10^9/L 10) Lymphocyte count <500/microliter 11) ALP >five times of upper limit of facility criteria 12) Total Bilirubin >three times of upper limit of facility criteria 13) Patients with past history of serious allergy 14) Patients with drug allergy for Tocilizumab 15) Patients with serious disease 16) Patients with active tuberculosis 17) Patients with interstitial pneumonia 18) Patients with past history of HIV, hepatitis B and hepatitis C 19) Patients having received live vaccine within 6 weeks before treatment 20) Patients who have been diagnosed cancer within 5 years 21) Patients with current and past history of intestinal diverticulum 22) Patients with infection within 4 weeks 23) Patients having received the other drug within 6 months 24) Patients who cannot receive intravenous therapy 25) Patients with current history of alcoholics and drug dependence, or with past history of alcoholics and drug dependence within 24 weeks 26) Patients with a history of receiving Tocilizumab 27) Expecting mothers or mothers with breast-feeding 28) Patients who will not use any way of contraception 29) Others not applicable person determined by a doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Double blind phase(Part1,2)] Part1:Proportion of Patients who achieved ACR 50% improvement at 4 weeks. Part2:Proportion of Patients who achieved ACR 50% improvement at 12 weeks [Open phase (part3)] Proportion of Patients who achieved ACR 50% improvement and whose corticosteroid level is 5mg/day or less at least 7 days before 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy] (Double blind phase(Part1,2)) *Decrease rate of corticosteroid at 12 weeks *Change of ACR20% and 50%, 70% improvement until 12 weeks *Change of SFS until 12 weeks *Change of ACR core set until 12 weeks *Absence of fever until 12 weeks *Absence of rash until 12 weeks *Change of serum ferritin until 12 weeks *Proportion of patients who achieved ACR 50% improvement and do not have fever at 12 weeks, and whose dose of corticosteroid decreased by over 20% *Proportion of patients with over 2-point decrease in SFS including a decrease in at least 1 of clinical variables at 4 weeks *Proportion of patients with over 2-point decrease in SFS including a decrease in at least 1 of clinical variables at 12 weeks (Open phase(part3)) *Proportion of patients with over 2-point decrease in SFS including a decrease in at least 1 of clinical variables at 52 weeks *Proportion of patients who achieved discontinuation of corticosteroid at 52 weeks *Changes of ACR 20%, 50% and 70% improvement at 52 weeks *Change of SFS at 52 weeks *Change of ACR core set at 52 weeks *Absence of fever at 52 weeks *Absence of rash at 52 weeks *Change of serum ferritin at 52 weeks *Decrease rate of and change in dose of corticosteroid at 52 weeks [Safety] Adverse event [PK] Serum Tocilizumab level, CRP, ESR, sIL-6 receptor | — |
Countries
Japan
Contacts
Public ContactYuto Fujiki
Keio University Hospital Clinical and Translational Research Center
Outcome results
None listed