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

Genentech

Status and phase

Terminated

Phase 3

Conditions

Lupus Nephritis

Systemic Lupus Erythematosus

Treatments

Drug: Mycophenolate Mofetil

Drug: Corticosteroids

Drug: Cyclophosphamide

Drug: Azathioprine

Drug: Ocrelizumab

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00626197

ACT4072g

WA20500

Details and patient eligibility

About

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.

Enrollment

381 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

381 participants in 3 patient groups, including a placebo group

OCR 400 mg + SOC

Experimental group

Description:

Participants received Ocrelizumab 400 mg i.v. infusion on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks plus SOC regimen.

Treatment:

Drug: Mycophenolate Mofetil

Drug: Cyclophosphamide

Drug: Corticosteroids

Drug: Ocrelizumab

Drug: Azathioprine

OCR 1000 mg + SOC

Experimental group

Description:

Participants received Ocrelizumab 1000 mg i.v. infusion on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks plus SOC regimen.

Treatment:

Drug: Mycophenolate Mofetil

Drug: Cyclophosphamide

Drug: Corticosteroids

Drug: Ocrelizumab

Drug: Azathioprine

Placebo + SOC

Placebo Comparator group

Description:

Participants received placebo i.v. infusion on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks plus SOC regimen.

Treatment:

Drug: Mycophenolate Mofetil