Status:
TERMINATED
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Lupus Nephritis
Systemic Lupus Erythematosus
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2013
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT00626197
Start Date
February 15 2008
End Date
October 28 2013
Last Update
December 22 2020
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