Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
Roche Pharma AG
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 16 years or above at the time of the screening
Ability and willingness to provide written informed consent and to comply with the schedule of protocol requirements
Diagnosis of SLE
Active lupus nephritis
You may not be if
Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia
Severe renal impairment
Lack of peripheral venous access
Pregnancy or breast feeding mothers
History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin
Known severe chronic pulmonary disease
Evidence of significant uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would preclude patient participation
Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) prior to screening
Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
Known active infection of any kind prior to Day 1
History of serious recurrent or chronic infection
History of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except basal cell carcinoma of the skin that has been excised and cured).
History of alcohol or drug abuse prior to screening
Major surgery prior to screening, excluding diagnostic surgery
Previous treatment with CAMPATH-1H
Previous treatment with a BAFF directed treatment (e.g. anti-BLyS) prior to screening
Previous treatment with a B-cell targeted therapy other than one directed at BAFF (e.g. anti-CD20, anti-CD22)
Treatment with any investigational agent prior to screening
Receipt of any live vaccines prior to Day 1
Intolerance or contraindication to oral or i.v. corticosteroids
Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but HBcAb positive may be enrolled with a negative DNA test
Clareo Health | A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
