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

Purpose

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	Intervention	Phase
Lupus Nephritis Systemic Lupus Erythematosus	Drug: corticosteroids Drug: cyclophosphamide Drug: mycophenolate mofetil Drug: ocrelizumab Drug: placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: systemic lupus erythematosus

MedlinePlus related topics: Lupus

Drug Information available for: Cyclophosphamide Mycophenolate mofetil

Genetic and Rare Diseases Information Center resources: Lupus Nephritis Glomerulonephritis

U.S. FDA Resources

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:

Patients who achieve a complete renal response (CRR) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
Patients who achieve a partial renal response (PRR) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients who achieve a renal response, major clinical response, or partial clinical response [ Time Frame: Weeks 48, 72, and 96 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	369
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2016
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626197

Sponsors and Collaborators

Genentech, Inc.

Roche Pharma AG

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00626197 History of Changes
Other Study ID Numbers:	ACT4072g WA20500
Study First Received:	February 20, 2008
Last Updated:	March 17, 2016
Health Authority:	United States: Food and Drug Administration

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 Mycophenolate mofetil 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 Enzyme Inhibitors Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on September 23, 2016

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