A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
This study is ongoing, but not recruiting participants.
Sponsor:
Genentech
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00626197
First received: February 20, 2008
Last updated: November 10, 2011
Last verified: November 2011
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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:
Drug Information available for:
Cyclophosphamide
Mycophenolic acid
Mycophenolate sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
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 Primary Completion Date: | January 2013 (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 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: | November 10, 2011 |
| 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 Antibiotics, Antineoplastic Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013