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
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: corticosteroids
Drug: immunosuppressive regime
Drug: methylprednisolone
Drug: ocrelizumab
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 Active Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33
Study Start Date: December 2007
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: corticosteroids
Oral repeating dose
Drug: immunosuppressive regime
Oral repeating dose
Drug: methylprednisolone
Intravenous repeating dose
Drug: ocrelizumab
Intravenous repeating dose
Placebo Comparator: 2 Drug: corticosteroids
Oral repeating dose
Drug: immunosuppressive regime
Oral repeating dose
Drug: methylprednisolone
Intravenous 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 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
  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: NCT00539838

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: NCT00539838     History of Changes
Other Study ID Numbers: ACT4071g, WA20499
Study First Received: October 3, 2007
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014