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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00626197
First Posted: February 29, 2008
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.
  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: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Patients who achieve a complete renal response (CRR) [ Time Frame: Week 48 ]
  • Patients who achieve a partial renal response (PRR) [ Time Frame: Week 48 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 381
Actual Study Start Date: February 2008
Study Completion Date: October 2013
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 20, 2008
First Posted: February 29, 2008
Last Update Posted: May 11, 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