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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Lupus Nephritis; Systemic Lupus Erythematosus	Drug: corticosteroids; Drug: cyclophosphamide; Drug: mycophenolate mofetil; Drug: ocrelizumab; Drug: placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	381 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus
Actual Study Start Date :	February 2008
Actual Primary Completion Date :	October 2009
Actual Study Completion Date :	October 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: corticosteroids; Intravenous and oral repeating dose Drug: cyclophosphamide; Intravenous repeating dose Drug: mycophenolate mofetil; oral repeating dose Drug: ocrelizumab; Intravenous repeating dose
Placebo Comparator: 2	Drug: corticosteroids; Intravenous and oral repeating dose Drug: cyclophosphamide; Intravenous repeating dose Drug: mycophenolate mofetil; oral repeating dose Drug: placebo; Intravenous repeating dose

Outcome Measures

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Primary Outcome Measures :

1. Patients who achieve a complete renal response (CRR) [ Time Frame: Week 48 ]
2. Patients who achieve a partial renal response (PRR) [ Time Frame: Week 48 ]

Secondary Outcome Measures :

1. Proportion of patients who achieve a renal response, major clinical response, or partial clinical response [ Time Frame: Weeks 48, 72, and 96 ]
2. Proportion of patients who achieve a reduction from baseline in SLEDAI 2K score, no worsening in physician's global assessment, no new BILAG A organ domain score, and no more than 1 new BILAG B organ domain score [ Time Frame: Week 48 ]
3. Change in SF-36 subscale FACTIT-Fatigue assessment, change from baseline in pain quality, and impact of pain on daily function [ Time Frame: Week 48 ]
4. Proportion of patients who achieve a CRR or PRR and who have received a daily dose of corticosteroids from Week 24 and average corticosteroid burden [ Time Frame: Week 48 ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Genentech, Inc.

Roche Pharma AG

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00626197 History of Changes
Other Study ID Numbers:	ACT4072g; WA20500
First Posted:	February 29, 2008
Last Update Posted:	May 10, 2017
Last Verified:	May 2017

Keywords provided by Genentech, Inc.:

SLE; Lupus; BELONG

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Kidney Diseases; Urologic Diseases; Glomerulonephritis; Cyclophosphamide; Mycophenolic Acid; Immunosuppressive Agents; Immunologic Factors	Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Antibiotics, Antineoplastic; Antibiotics, Antitubercular; Antitubercular Agents; Anti-Bacterial Agents; Anti-Infective Agents; Enzyme Inhibitors