Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00539838
Recruitment Status : Terminated (The study was terminated prematurely when the decision was made that ocrelizumab was not likely to benefit this patient population.)
First Posted : October 5, 2007
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE October 3, 2007
First Posted Date  ICMJE October 5, 2007
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2007)
The proportion of patients who achieve clinical response
Change History Complete list of historical versions of study NCT00539838 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
  • Proportion of patients with disease activity [ Time Frame: Length of study ]
  • Patient Symptoms and Function (Quality of Life) [ Time Frame: Week 48 ]
  • Proportion of patients who achieve a clinical response who have received a corticosteroid dose [ Time Frame: Week 24 to Week 48 ]
  • Average corticosteroid burden [ Time Frame: Week 16 to Week 48 ]
  • Proportion of patients who have stopped oral immunosuppressant [ Time Frame: Beyond Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2007)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Prednisone
    Oral repeating dose
  • Drug: immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)
    Oral repeating dose
  • Drug: methylprednisolone
    Intravenous repeating dose
  • Drug: ocrelizumab
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: Prednisone
    • Drug: immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)
    • Drug: methylprednisolone
    • Drug: ocrelizumab
  • Placebo Comparator: 2
    Interventions:
    • Drug: Prednisone
    • Drug: immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)
    • Drug: methylprednisolone
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 23, 2012)
33
Original Enrollment  ICMJE
 (submitted: October 3, 2007)
423
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00539838
Other Study ID Numbers  ICMJE ACT4071g
WA20499
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Roche Pharma AG
Investigators  ICMJE
Study Director: Jorn Drappa, M.D., Ph.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date May 2017

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