A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00808210
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- Age >= 18 years
- Current treatment for RA on an outpatient basis
- Active disease
- Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
- Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons
- Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
- Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
- Treatment with more than one prior anti-TNFα therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocrelizumab 200mg Methotrexate Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. Ocrelizumab 200mg Methylprednisolone Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. Ocrelizumab 200mg Placebo Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. Infliximab 5mg/kg Methotrexate Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. Infliximab 5mg/kg Placebo Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. Ocrelizumab 200mg Ocrelizumab Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. Infliximab 5mg/kg Infliximab Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. Infliximab 5mg/kg Methylprednisolone Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.
- Primary Outcome Measures
Name Time Method Change From Baseline in DAS28(ESR) at Week 20 Week 20
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Clinical Response of 20% According to ACR Criteria Baseline up to 30 months Percentage of Participants With Clinical Response of 50% According to ACR Criteria Baseline up to 30 months Percentage of Participants With Clinical Response of 70% According to ACR Criteria Baseline up to 30 months European League Against Rheumatism (EULAR) Response Rates Baseline up to 30 months Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Baseline up to 30 months Change in Fatigue Visual Analog Scale Score (VAS) Baseline up to 30 months Percentage of Participants With Adverse Events (AEs) Baseline up to 30 months
Trial Locations
- Locations (52)
Ohio State Univ Med Center
🇺🇸Columbus, Ohio, United States
Ctr for Inflammatory Disease
🇺🇸Nashville, Tennessee, United States
Phillip A Waller MD, PA
🇺🇸Houston, Texas, United States
Texas Arthritis Research Center
🇺🇸San Antonio, Texas, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Clayton Medical Research
🇺🇸Saint Louis, Missouri, United States
Rheumatology Associates
🇺🇸Birmingham, Alabama, United States
Robert W. Levin MD - PP
🇺🇸Dunedin, Florida, United States
Science and Research Institute, Inc.
🇺🇸Jupiter, Florida, United States
Institute of Arthritis Research
🇺🇸Idaho Falls, Idaho, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Illinois Bone & Joint Inst.
🇺🇸Morton Grove, Illinois, United States
Arthritis Associates
🇺🇸Hixson, Tennessee, United States
Providence Arthritis Center
🇺🇸Portland, Oregon, United States
Columbia Arthritis Center (Partnership Practice)
🇺🇸Columbia, South Carolina, United States
Amarillo Center For Clinical Research
🇺🇸Amarillo, Texas, United States
Westroads Medical Group
🇺🇸Omaha, Nebraska, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Dr. Brigid Freyne, MD
🇺🇸Murrieta, California, United States
Agilence Arthritis and Osteoporosis Medical Center, Inc.
🇺🇸Whittier, California, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
RASF-Clinical Research Center
🇺🇸Boca Raton, Florida, United States
Arthritis Res & Treatment
🇺🇸Macon, Georgia, United States
Harbin Clinic
🇺🇸Rome, Georgia, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Graves Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Rheumatology, P.C.; Medical Arts Building
🇺🇸Kalamazoo, Michigan, United States
Private Practice - Rosenberg
🇺🇸Florissant, Missouri, United States
Arthritis Associates of Mississippi
🇺🇸Jackson, Mississippi, United States
Shores Rheumatology
🇺🇸Saint Clair Shores, Michigan, United States
Fiechtner Research Inc
🇺🇸Lansing, Michigan, United States
Billings Clinic; Research Center
🇺🇸Billings, Montana, United States
Jackson Arthritis Clinic
🇺🇸Flowood, Mississippi, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Arthritis & Osteoporosis Center
🇺🇸Brooklyn, New York, United States
Dartmouth-Hitchcock Medical Center, Rheumatology 5C
🇺🇸Lebanon, New Hampshire, United States
Regional Clinical Research
🇺🇸Binghamton, New York, United States
Southern Tier Arthritis & Rheumatism
🇺🇸Olean, New York, United States
Arthritis Center of Reno
🇺🇸Reno, Nevada, United States
Buffalo Rheumatology Associates
🇺🇸Orchard Park, New York, United States
Barada,Harrell,Toohey&Bellhorn
🇺🇸Durham, North Carolina, United States
Physicians East Pa
🇺🇸Greenville, North Carolina, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Lehigh Valley Physicians Group
🇺🇸Allentown, Pennsylvania, United States
Ramesh Gupta - PP
🇺🇸Memphis, Tennessee, United States
South Carolina Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Southwest Rheumatology
🇺🇸Mesquite, Texas, United States
Piedmont Arthritis Clinic
🇺🇸Greenville, South Carolina, United States
Lovelace Scientific Resources
🇺🇸Sarasota, Florida, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Rheumatology Associates of Central Florida
🇺🇸Orlando, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States