A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

NCT ID: NCT00539838

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-19
• Study Completion Date: 2011-07-12

Brief Summary

This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.

Conditions

Systemic Lupus Erythematosus

Study Design

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

Study Groups

Ocrelizumab 1000 mg

Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Oral repeating dose

Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)

Intervention Type: DRUG

Oral repeating dose

Methylprednisolone

Intervention Type: DRUG

Intravenous repeating dose

Ocrelizumab

Intervention Type: DRUG

Intravenous repeating dose

Ocrelizumab 400 mg

Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Oral repeating dose

Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)

Intervention Type: DRUG

Oral repeating dose

Methylprednisolone

Intervention Type: DRUG

Intravenous repeating dose

Ocrelizumab

Intervention Type: DRUG

Intravenous repeating dose

Placebo

Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Group Type: PLACEBO_COMPARATOR

Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)

Intervention Type: DRUG

Oral repeating dose

Placebo

Intervention Type: DRUG

Intravenous repeating dose

Interventions

Prednisone

Oral repeating dose

Intervention Type: DRUG

Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)

Oral repeating dose

Intervention Type: DRUG

Methylprednisolone

Intravenous repeating dose

Intervention Type: DRUG

Ocrelizumab

Intravenous repeating dose

Intervention Type: DRUG

Placebo

Intravenous repeating dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 16 years or above at the time of screening
• Diagnosis of SLE
• Active disease at screening

Exclusion Criteria

• Presence of active moderate to severe glomerulonephritis
• Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia
• 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 or uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would impair patient participation
• Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled) at any time in the 52 weeks prior to screening
• Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
• Known active infection of any kind (but excluding fungal infection of nail beds or oral thrush which has resolved before Day 1) within 30 days prior to Day 1. In addition, any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1
• History of serious recurrent or chronic infection
• History of cancer (except basal cell carcinoma of the skin that has been excised and cured)
• History of alcohol or drug abuse in the 52 weeks prior to screening
• Major surgery in the 4 weeks prior to screening excluding diagnostic surgery
• Previous treatment with CAMPATH-1H
• Previous treatment with a BAFF directed treatment in the 12 months prior to screening
• Previous treatment with a B-cell targeted therapy other than one directed at BAFF
• Treatment with any investigational agent, other than those above, in the 28 days prior to screening or five half-lives of the investigational drug (whichever is longer)
• Receipt of any live vaccine in the 6 weeks prior to Day 1
• Intolerance or contraindication to oral or i.v. corticosteroids
• Treatment with a second immunosuppressive or immunomodulatory drug in the 8 weeks prior to Day 1
• Prednisone dose of ≥ 0.7 mg/kg/day (or equivalent) for > 7 of the previous 30 days prior to screening
• Treatment with cyclophosphamide or a calcineurin inhibitor in the 12 weeks prior to screening
• 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

Jorn Drappa, M.D., Ph.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

WA20499

Identifier Type: -

Identifier Source: secondary_id

ACT4071g

Identifier Type: -

Identifier Source: org_study_id