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
Overview
- Phase
- Phase 3
- Intervention
- Prednisone
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Genentech, Inc.
- Enrollment
- 33
- Primary Endpoint
- Number of Participants With Partial Clinical Response (PCR)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
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
Intervention: Prednisone
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
Intervention: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)
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
Intervention: Methylprednisolone
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
Intervention: Ocrelizumab
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
Intervention: Prednisone
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
Intervention: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)
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
Intervention: Methylprednisolone
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
Intervention: Ocrelizumab
Placebo
Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
Intervention: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate)
Placebo
Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Partial Clinical Response (PCR)
Time Frame: Week 48
Number of Participants With Major Clinical Response (MCR)
Time Frame: Week 48
Number of Non-responders (NR)
Time Frame: Week 48
Secondary Outcomes
- Time Adjusted Mean SLEDAI-2K Score(Week 48)
- Change in SF-36 Subscale And Summary Scores From Baseline At Week 48(Baseline, Week 48)
- Number of Participants Who Achieved a BILAG Score of C or Better at Week 24.(Week 24)
- 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(Week 48 to Week 96)
- Time to First Moderate to Severe Flare(Week 48 to Week 96)
- Annualized Flare Rate(Week 48 to Week 96)
- Number of Participants Who Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 72(Week 48 to Week 72)
- Number of Participants Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 96(Week 48 to Week 96)
- Change In FACIT-Fatigue Assessment From Baseline To Week 48(Baseline, Week 48)
- Change From Baseline In Pain Quality And Impact Of Pain On Daily Function Measured By The Brief Pain Inventory Short Form At Week 48(Baseline, Week 48)
- The EQ-5D Single Index Utility Score At Week 48(Baseline, Week 48)
- Number of Participants With Adverse Events(Up to 2.5 years)