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

NCT ID: NCT00626197

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 381 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-15
• Study Completion Date: 2013-10-28

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 of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.

Conditions

Lupus Nephritis; Systemic Lupus Erythematosus

Keywords

SLE; Lupus; BELONG

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

OCR 400 mg + SOC

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.

Group Type: EXPERIMENTAL

Corticosteroids

Intervention Type: DRUG

Intravenous and oral repeating dose

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.

Mycophenolate Mofetil

Intervention Type: DRUG

Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administed at a dose and as per schedule in arm description

Azathioprine

Intervention Type: DRUG

Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.

OCR 1000 mg + SOC

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.

Group Type: EXPERIMENTAL

Corticosteroids

Intervention Type: DRUG

Intravenous and oral repeating dose

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.

Mycophenolate Mofetil

Intervention Type: DRUG

Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab was administed at a dose and as per schedule in arm description

Azathioprine

Intervention Type: DRUG

Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.

Placebo + SOC

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.

Group Type: PLACEBO_COMPARATOR

Corticosteroids

Intervention Type: DRUG

Intravenous and oral repeating dose

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.

Mycophenolate Mofetil

Intervention Type: DRUG

Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.

Placebo

Intervention Type: DRUG

Placebo was administered as per schedule in arm description

Azathioprine

Intervention Type: DRUG

Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.

Interventions

Corticosteroids

Intravenous and oral repeating dose

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.

Intervention Type: DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.

Intervention Type: DRUG

Ocrelizumab

Ocrelizumab was administed at a dose and as per schedule in arm description

Intervention Type: DRUG

Placebo

Placebo was administered as per schedule in arm description

Intervention Type: DRUG

Azathioprine

Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Countries

United States

Other Identifiers

WA20500

Identifier Type: -

Identifier Source: secondary_id

ACT4072g

Identifier Type: -

Identifier Source: org_study_id