A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

This study has been terminated.
(The study was terminated prematurely when the decision was made that ocrelizumab was not likely to benefit this patient population.)
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00539838
First received: October 3, 2007
Last updated: January 17, 2013
Last verified: January 2013

October 3, 2007
January 17, 2013
December 2007
July 2011   (final data collection date for primary outcome measure)
Proportion of patients with a clinical response in the following (mutually exclusive) categories: 1) major clinical response; 2) partial clinical response; 3) non-responder [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
The proportion of patients who achieve clinical response
Complete list of historical versions of study NCT00539838 on ClinicalTrials.gov Archive Site
  • Proportion of patients with disease activity [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Patient Symptoms and Function (Quality of Life) [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve a clinical response who have received a corticosteroid dose [ Time Frame: Week 24 to Week 48 ] [ Designated as safety issue: No ]
  • Average corticosteroid burden [ Time Frame: Week 16 to Week 48 ] [ Designated as safety issue: No ]
  • Proportion of patients who have stopped oral immunosuppressant [ Time Frame: Beyond Week 48 ] [ Designated as safety issue: No ]
  • Incidence of adverse events
  • Incidence of clinical laboratory abnormalities
  • Incidence of human anti-human antibodies (HAHA)
  • Serum levels of ocrelizumab
  • Circulating B-cell counts
  • HAHA rate and level
  • Quality of life
Not Provided
Not Provided
 
A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)
A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: corticosteroids
    Oral repeating dose
  • Drug: immunosuppressive regime
    Oral repeating dose
  • Drug: methylprednisolone
    Intravenous repeating dose
  • Drug: ocrelizumab
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
  • Experimental: 1
    Interventions:
    • Drug: corticosteroids
    • Drug: immunosuppressive regime
    • Drug: methylprednisolone
    • Drug: ocrelizumab
  • Placebo Comparator: 2
    Interventions:
    • Drug: corticosteroids
    • Drug: immunosuppressive regime
    • Drug: methylprednisolone
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
September 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 16 years or above at the time of screening
  • Diagnosis of SLE
  • Active disease at screening

Exclusion Criteria:

  • Presence of active moderate to severe glomerulonephritis
  • Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia
  • 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 or uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would impair patient participation
  • Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled) at any time in the 52 weeks prior to screening
  • Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection
  • Known active infection of any kind (but excluding fungal infection of nail beds or oral thrush which has resolved before Day 1) within 30 days prior to Day 1. In addition, any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives in the 30 days prior to Day 1 or oral anti-infectives in the 14 days prior to Day 1
  • History of serious recurrent or chronic infection
  • History of cancer (except basal cell carcinoma of the skin that has been excised and cured)
  • History of alcohol or drug abuse in the 52 weeks prior to screening
  • Major surgery in the 4 weeks prior to screening excluding diagnostic surgery
  • Previous treatment with CAMPATH-1H
  • Previous treatment with a BAFF directed treatment in the 12 months prior to screening
  • Previous treatment with a B-cell targeted therapy other than one directed at BAFF
  • Treatment with any investigational agent, other than those above, in the 28 days prior to screening or five half-lives of the investigational drug (whichever is longer)
  • Receipt of any live vaccine in the 6 weeks prior to Day 1
  • Intolerance or contraindication to oral or i.v. corticosteroids
  • Treatment with a second immunosuppressive or immunomodulatory drug in the 8 weeks prior to Day 1
  • Prednisone dose of ≥ 0.7 mg/kg/day (or equivalent) for > 7 of the previous 30 days prior to screening
  • Treatment with cyclophosphamide or a calcineurin inhibitor in the 12 weeks prior to screening
  • Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but HBcAb positive may be enrolled with a negative DNA test
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00539838
ACT4071g, WA20499
Not Provided
Genentech
Genentech
Roche Pharma AG
Study Director: Jorn Drappa, M.D., Ph.D. Genentech
Genentech
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP