A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (B… (NCT00626197) | Clinical Trial Compass
TerminatedPhase 3
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
Stopped: Study was terminated due to an imbalance of serious and opportunistic infections in the ocrelizumab treated patients versus the placebo arm.
381 participantsStarted 2008-02-15
Plain-language 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 of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.
Who can participate
Age range16 Years
SexALL
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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 treatmen…
What they're measuring
1
Number of Participants Who Achieved Complete Renal Response (CRR)
Timeframe: Week 48
2
Percentage of Participants Who Achieved Overall Response