Systemic lupus erythematosus (SLE)
Conditions
Interventions
investigational material(s)
Generic name etc : Rontalizumab
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investi
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Diagnosis of SLE based on meeting at least 4 of 11 of the 1997 American College of Rheumatology (ACR) classification criteria prior to informed consent and duration of SLE of >/= 12 months. (2)For patients with reproductive potential (males and females), able to use a reliable means of contraception (3)For female patients, uterine cervical cytology results of cytology class II or below confirmed on uterine cervical cancer testing.
Exclusion criteria
Exclusion criteria: (1)Received >20 mg/day or 0.5 mg/kg/day (body weights /= 4 days within 30 days prior to informed consent (2)Received any of the drug below or transfusions within three months prior to informed consent - pulse dose corticosteroids, - azathioprine, - mizoribine, - methotrexate, - mycophenolate mofetil, - cyclosporine, - tacrolimus, - sirolimus, - monoclonal antibody - intravenous immunoglobulin (IVIG) (3)Received cyclophosphamide within two years prior to informed consent (4)Previously received another study drug directed against IFNalpha (5)History of B-cell depleting therapy or anti-BLYS therapy within 12 months prior to informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Pharmacokinetics Observation, Laboratory tests | — |
Outcome results
None listed