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

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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
Results First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Prednisone Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) Drug: Methylprednisolone Drug: Ocrelizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : December 19, 2007
Actual Primary Completion Date : July 12, 2011
Actual Study Completion Date : July 12, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: Ocrelizumab 1000 mg
Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks
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

Experimental: Ocrelizumab 400 mg
Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks
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

Placebo Comparator: Placebo
Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)
Oral repeating dose

Drug: Placebo
Intravenous repeating dose




Primary Outcome Measures :
  1. Number of Participants With Major Clinical Response (MCR) [ Time Frame: Week 48 ]
  2. Number of Participants With Partial Clinical Response (PCR) [ Time Frame: Week 48 ]
  3. Number of Non-responders (NR) [ Time Frame: Week 48 ]

Secondary Outcome Measures :
  1. Number of Participants Who Achieved a BILAG Score of C or Better at Week 24. [ Time Frame: Week 24 ]
  2. Time Adjusted Mean SLEDAI-2K Score [ Time Frame: Week 48 ]
  3. Annualized Flare Rate [ Time Frame: Week 48 to Week 96 ]
  4. Time to First Moderate to Severe Flare [ Time Frame: Week 48 to Week 96 ]
  5. Number of Participants Who Achieved A Major Or Partial Clinical Response At Week 48 (PCR Plus MCR Proportion), Who Did Not Experience A Flare Before Week 96 [ Time Frame: Week 48 to Week 96 ]
  6. Number of Participants Who Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 72 [ Time Frame: Week 48 to Week 72 ]
  7. Number of Participants Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 96 [ Time Frame: Week 48 to Week 96 ]
  8. Change in SF-36 Subscale And Summary Scores From Baseline At Week 48 [ Time Frame: Baseline, Week 48 ]
  9. Change In FACIT-Fatigue Assessment From Baseline To Week 48 [ Time Frame: Baseline, Week 48 ]
  10. Change From Baseline In Pain Quality And Impact Of Pain On Daily Function Measured By The Brief Pain Inventory Short Form At Week 48 [ Time Frame: Baseline, Week 48 ]
  11. The EQ-5D Single Index Utility Score At Week 48 [ Time Frame: Baseline, Week 48 ]
  12. Number of Participants With Adverse Events [ Time Frame: Up to 2.5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539838


Sponsors and Collaborators
Genentech, Inc.
Roche Pharma AG
Investigators
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Study Director: Jorn Drappa, M.D., Ph.D. Genentech, Inc.
Additional Information:
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00539838    
Other Study ID Numbers: ACT4071g
WA20499
First Posted: October 5, 2007    Key Record Dates
Results First Posted: September 17, 2020
Last Update Posted: September 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Keywords provided by Genentech, Inc.:
SLE
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Prednisone
Methylprednisolone
Methotrexate
Azathioprine
Immunosuppressive Agents
Ocrelizumab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors