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
NCT ID: NCT00808210
Last Updated: 2020-11-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
28 participants
INTERVENTIONAL
2009-03-05
2012-11-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ocrelizumab 200mg
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.
Methotrexate
Oral or parenteral repeating dose
Methylprednisolone
Intravenous repeating dose
Ocrelizumab
Intravenous repeating dose
Placebo
Intravenous repeating dose
Infliximab 5mg/kg
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
Intravenous repeating dose
Methotrexate
Oral or parenteral repeating dose
Methylprednisolone
Intravenous repeating dose
Placebo
Intravenous repeating dose
Interventions
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Infliximab
Intravenous repeating dose
Methotrexate
Oral or parenteral repeating dose
Methylprednisolone
Intravenous repeating dose
Ocrelizumab
Intravenous repeating dose
Placebo
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Rheumatology Associates
Birmingham, Alabama, 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
Robert W. Levin MD - PP
Dunedin, Florida, United States
Science and Research Institute, Inc.
Jupiter, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
Lovelace Scientific Resources
Sarasota, Florida, United States
Arthritis Res & Treatment
Macon, Georgia, United States
Harbin Clinic
Rome, Georgia, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Illinois Bone & Joint Inst.
Morton Grove, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Hurley Medical Center
Flint, Michigan, United States
Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan, United States
Fiechtner Research Inc
Lansing, Michigan, United States
Shores Rheumatology
Saint Clair Shores, Michigan, United States
Jackson Arthritis Clinic
Flowood, Mississippi, United States
Arthritis Associates of Mississippi
Jackson, Mississippi, United States
Private Practice - Rosenberg
Florissant, Missouri, United States
Clayton Medical Research
St Louis, Missouri, United States
Billings Clinic; Research Center
Billings, Montana, United States
Billings Clinic
Billings, Montana, United States
Westroads Medical Group
Omaha, Nebraska, United States
Arthritis Center of Reno
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center, Rheumatology 5C
Lebanon, New Hampshire, United States
Regional Clinical Research
Binghamton, New York, United States
Arthritis & Osteoporosis Center
Brooklyn, New York, United States
Southern Tier Arthritis & Rheumatism
Olean, New York, 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
Ohio State Univ Med Center
Columbus, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Providence Arthritis Center
Portland, Oregon, United States
Lehigh Valley Physicians Group
Allentown, Pennsylvania, United States
Arthritis Associates
Erie, Pennsylvania, United States
Columbia Arthritis Center (Partnership Practice)
Columbia, South Carolina, United States
Piedmont Arthritis Clinic
Greenville, South Carolina, United States
South Carolina Research Center
Myrtle Beach, South Carolina, United States
Arthritis Associates
Hixson, Tennessee, United States
Ramesh Gupta - PP
Memphis, Tennessee, United States
Ctr for Inflammatory Disease
Nashville, Tennessee, United States
Amarillo Center For Clinical Research
Amarillo, Texas, United States
Phillip A Waller MD, PA
Houston, Texas, United States
Southwest Rheumatology
Mesquite, Texas, United States
Texas Arthritis Research Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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GA00931
Identifier Type: -
Identifier Source: secondary_id
ACT4562g
Identifier Type: -
Identifier Source: org_study_id