A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
NCT ID: NCT01382940
Last Updated: 2017-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
351 participants
INTERVENTIONAL
2011-07-26
2013-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab
Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
rituximab
1000 mg in 250 mL intravenous infusion
methotrexate
10 to 25 mg/week (oral or parenteral)
methylprednisolone
100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion
acetaminophen
1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion
antihistamine
50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion
Interventions
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rituximab
1000 mg in 250 mL intravenous infusion
methotrexate
10 to 25 mg/week (oral or parenteral)
methylprednisolone
100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion
acetaminophen
1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion
antihistamine
50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rheumatoid arthritis of ≥ 6 months duration, diagnosed according to the revised 1987 American College of Rheumatology criteria
* Inadequate response to at least one approved anti-TNF agent (adalimumab, etanercept, infliximab, golimumab, or certolizumab)
* Patients who have received 1 to 2 prior courses of rituximab (RTX) may be enrolled, provided their most recent course of RTX occurred over 6 months but no more than 9 months prior to baseline. The RTX dosage must have been two 1000 mg infusions per course administered at the standard approved rate
* Methotrexate treatment between 10 and 25 mg/week (oral or parenteral) for at least 8 weeks immediately prior to baseline
Exclusion Criteria
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Functional class IV as defined by American College of Rheumatology (ACR) criteria
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
* Previous serious infusion reaction to any prior biologic therapy
* Known active current or history of recurrent infection
* Evidence of chronic hepatitis B or C infection
* Pregnant or lactating women
* Body weight of \> 150 kg
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Uni Of Alabama,Birmingham; Medicine - Rheumatology
Birmingham, Alabama, United States
Clnical & Translational Reseach Center for Alabama, PC
Tuscaloosa, Alabama, United States
ArthroCare, Arthritis Care; and Research P.C.
Gilbert, Arizona, United States
Valley Arthritis Care
Phoenix, Arizona, United States
Catalina Pointe Rheumatology
Tucson, Arizona, United States
Medvin Clinical Research
Covina, California, United States
Triwest Research Associates
La Mesa, California, United States
Medvin Clinical Research
Los Angeles, California, United States
Brigid Freyne-Private Practice; Internal Medicine, Rheum
Murrieta, California, United States
Desert Medical Advances; Rheumatology
Palm Desert, California, United States
San Diego Arthritis Med Clnc
San Diego, California, United States
Pacific Arthritis Ctr Med Grp
Santa Maria, California, United States
Inland Rheumatology; Clinical Trials, Inc.
Upland, California, United States
Medvin Clinical Research
Whittier, California, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Rheum & Internal Med Assoc-Bri
Bridgeport, Connecticut, United States
Arthritis & Osteoporosis Center Pc
Hamden, Connecticut, United States
Rheumatolgy Consultants of Deleware
Lewes, Delaware, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, United States
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida, United States
Florida Arthritis Center, PI
Lake Mary, Florida, United States
Omega ResearchConsultants LLC
Orlando, Florida, United States
Millenium Research
Ormond Beach, Florida, United States
Arthritis Center Palm Harbor
Palm Harbor, Florida, United States
Arthritis Rsrch of Florida, Inc.
Palm Harbor, Florida, United States
Center For Arthritis; Research Dept
South Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Florida Medical Clinic; Clinical Research
Zephyrhills, Florida, United States
Parris & Associates
Lawrenceville, Georgia, United States
St. Luke's Intermountain Research Center
Boise, Idaho, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Quad City Rheumatology, Sc
Moline, Illinois, United States
Physician'S Clinic of Iowa
Cedar Rapids, Iowa, United States
Bluegrass Comm Research, Inc.
Lexington, Kentucky, United States
Klein & Associates, M.D. P.A.
Cumberland, Maryland, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
St. Luke's Hospital Association of Duluth
Duluth, Minnesota, United States
Arthritis and Osteoporosis; Treatment and Research Center
Flowood, Mississippi, United States
Jackson Arthritis Clinic
Flowood, Mississippi, United States
North Mississippi Med Clinics, Inc.
Tupelo, Mississippi, United States
David S Rosenberg
Florissant, Missouri, United States
Arthritis Center of Reno
Reno, Nevada, United States
Rheumatology Research Group
Lebanon, New Hampshire, United States
Rheumatology Associates Of New Jersey
Teaneck, New Jersey, United States
The Center for Rheumatology
Albany, New York, United States
Arthritis & Osteoporosis Center
Brooklyn, New York, United States
NYU Center for Musculoskeletal Care
New York, New York, United States
Buffalo Rheumatology Associates
Orchard Park, New York, United States
Office of Premier Chatpar Md
Plainview, New York, United States
Aair Research Center
Rochester, New York, United States
Rheumatology Associates of Long Island
Smithtown, New York, United States
Arthritis Health Associates; Clinical Research
Syracuse, New York, United States
Arth&OsteoConsof theCarolinas-Charlotte
Charlotte, North Carolina, United States
Box Arthritis & Rheumatology
Charlotte, North Carolina, United States
Carolina Bone & Joint P.A.
Charlotte, North Carolina, United States
Physicians East Pa
Greenville, North Carolina, United States
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, United States
Crystal Arthritis Center, Inc.
Akron, Ohio, United States
CarePoint East
Columbus, Ohio, United States
Stat Research, Inc
Dayton, Ohio, United States
Paramount Medical Research
Middleburg Heights, Ohio, United States
LION Research
Norman, Oklahoma, United States
Arthritis and Rheumatology; Center of Oklahoma PLLC
Oklahoma City, Oklahoma, United States
East Penn Rheumatology Associates, Pc
Bethlehem, Pennsylvania, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Pivotal Clinical Research, Llc
Perkasie, Pennsylvania, United States
Arthritis Group
Philadelphia, Pennsylvania, United States
Rheumatic Disease Associates; Clinical Research Unit
Willow Grove, Pennsylvania, United States
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States
Pennsylvania Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
Rheumatology Associates
Charleston, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Ramesh Gupta - PP
Memphis, Tennessee, United States
Amarillo Center For Clinical Research
Amarillo, Texas, United States
Lovelace Scientific Resources Inc.
Austin, Texas, United States
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, United States
Arthritis Centers of Texas
Dallas, Texas, United States
Southwest Rheumatology
Mesquite, Texas, United States
Arthritis Clinic of Northern Virginia
Arlington, Virginia, United States
Apex Clinical Research
Kennewick, Washington, United States
Seattle Arthritis Clinic
Seattle, Washington, United States
Arthritis Northwest, Spokane
Spokane, Washington, United States
Cedar Medical Center
Tacoma, Washington, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Countries
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Other Identifiers
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ML25641
Identifier Type: -
Identifier Source: org_study_id
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