A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)
NCT ID: NCT01662063
Last Updated: 2016-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
218 participants
INTERVENTIONAL
2012-08-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SC TCZ QW
Participants who received IV TCZ in the previous trial will be switched to SC TCZ 162 mg QW, and those who received SC TCZ will continue at their same dosage of SC TCZ 162 mg QW. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.
Tocilizumab
TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
SC TCZ Q2W
Participants who received SC TCZ will continue at their same dosage of SC TCZ 162 mg Q2W. Tocilizumab will be given for an additional 96 weeks in this open-label extension study.
Tocilizumab
TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
Interventions
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Tocilizumab
TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving treatment on an outpatient basis
* Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol
Exclusion Criteria
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Evidence of serious uncontrolled concomitant disease or disorder
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
* Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
* History of or currently active primary or secondary immunodeficiency
* Oral corticosteroids at greater than (\>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose
* Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline
* Treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and enrollment in the long-term extension study
* Pregnant or breastfeeding women
* History of alcohol, drug, or chemical abuse within 1 year prior to Screening
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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Tuscaloosa, Alabama, United States
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Fullerton, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Leandro, California, United States
Upland, California, United States
Van Nuys, California, United States
West Hills, California, United States
Whittier, California, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Trumbull, Connecticut, United States
Jupiter, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Venice, Florida, United States
Gainesville, Georgia, United States
Coeur d'Alene, Idaho, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Morton Grove, Illinois, United States
Springfield, Illinois, United States
Vernon Hills, Illinois, United States
Wichita, Kansas, United States
Monroe, Louisiana, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Worcester, Massachusetts, United States
Saint Claire Shores, Michigan, United States
Eagan, Minnesota, United States
Flowood, Mississippi, United States
Jackson, Mississippi, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Lebanon, New Hampshire, United States
Clifton, New Jersey, United States
Freehold, New Jersey, United States
Manalapan, New Jersey, United States
Voorhees Township, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Orchard Park, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Houston, Texas, United States
Houston, Texas, United States
Nassau Bay, Texas, United States
Olympia, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Wenatchee, Washington, United States
Ponce, , Puerto Rico
Countries
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References
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Kivitz A, Wallace T, Olech E, Borofsky M, Devenport J, Pei J, Michalska M. Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase 3b Long-term Extension Study. Rheumatol Ther. 2016 Dec;3(2):291-304. doi: 10.1007/s40744-016-0043-1. Epub 2016 Sep 24.
Other Identifiers
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ML28338
Identifier Type: -
Identifier Source: org_study_id
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