Clinical trial of Tocilizumab for adult onset still disease

Not Applicable

• Conditions: Adult onset still diseas

• Registration Number: JPRN-UMIN000012987
• Lead Sponsor: Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified