A Phase I study of rontalizumab
- Conditions
- Systemic lupus erythematosus (SLE)
- Registration Number
- JPRN-jRCT2080221821
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 21
(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.
(1)Received >20 mg/day or 0.5 mg/kg/day (body weights <40 kg) prednisolone equivalent corticosteroids for >/= 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Pharmacokinetics<br>Observation, Laboratory tests
- Secondary Outcome Measures
Name Time Method