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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00626197
First received: February 20, 2008
Last updated: January 22, 2014
Last verified: January 2014
  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:


Further study details as provided by Genentech:

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: December 2014
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
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
Roche Pharma AG
Investigators
Study Director: Jorn Drappa, M.D., Ph.D. Genentech
  More Information

Additional Information:
No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00626197     History of Changes
Other Study ID Numbers: ACT4072g, WA20500
Study First Received: February 20, 2008
Last Updated: January 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
SLE
Lupus
BELONG

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Cyclophosphamide
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Enzyme Inhibitors
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on August 18, 2014