A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus

This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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