A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs
1 other identifier
interventional
886
1 country
227
Brief Summary
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started May 2009
Shorter than P25 for phase_3 rheumatoid-arthritis
227 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 17, 2012
CompletedOctober 25, 2012
October 1, 2012
1.2 years
April 29, 2009
February 28, 2012
October 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period
An SAE was any adverse event that at any dose fulfilled at least one of the following criteria: * Was fatal (results in death) * Was life-threatening * Required in-patient hospitalization or prolongation of existing hospitalization * Resulted in persistent or significant disability/incapacity * Was a congenital anomaly/birth defect * Was medically significant or required intervention to prevent one or other of the outcomes listed above.
24 Weeks
Secondary Outcomes (9)
Percentage of Participants Experiencing Serious Adverse Events of Special Interest
24 Weeks
Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest
24 Weeks
Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24
Weeks 8,16,24
Change From Baseline in DAS28 Score at Weeks 8, 16 and 24
Baseline, Weeks 8,16,24
Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24
Baseline, Weeks 8,16,24
- +4 more secondary outcomes
Study Arms (3)
Tocilizumab 8 mg/kg Monotherapy
EXPERIMENTALParticipants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Tocilizumab 4 mg/kg + DMARD
EXPERIMENTALParticipants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Tocilizumab 8 mg/kg + DMARD
EXPERIMENTALParticipants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Interventions
8 mg/kg intravenous every 4 weeks for 24 weeks
Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- moderate to severe active rheumatoid arthritis for \>6 months;
- inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
- Swollen joint count (SJC) \>/=4 and Tender joint count (TJC) \>/=4
- body weight \</=150kg
- current permitted non-biologic DMARDs must be on stable dose for \>/= 7 weeks prior to baseline;
You may not qualify if:
- history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
- treatment with rituximab within 6 months before screening;
- intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
- known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (227)
Unknown Facility
Anniston, Alabama, 36207, United States
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Birmingham, Alabama, 35205, United States
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Birmingham, Alabama, 35294, United States
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Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36111, United States
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Tuscaloosa, Alabama, 35406, United States
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Hot Springs, Arizona, 71913, United States
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Paradise Valley, Arizona, 85253, United States
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Peoria, Arizona, 85381, United States
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Scottsdale, Arizona, 85251, United States
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Scottsdale, Arizona, 85258, United States
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Tucson, Arizona, 85704, United States
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Fayetteville, Arkansas, 27203, United States
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Fort Smith, Arkansas, 72903, United States
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Jonesboro, Arkansas, 72401, United States
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Little Rock, Arkansas, 72205, United States
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Covina, California, 91723, United States
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Escondido, California, 92025, United States
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Fullerton, California, 92835, United States
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Huntington Beach, California, 92646, United States
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La Jolla, California, 92037, United States
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Lakewood, California, 90712, United States
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Long Beach, California, 90808, United States
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Los Angeles, California, 90048, United States
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Murrieta, California, 92563, United States
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Newport Beach, California, 92663, United States
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Pasadena, California, 91107, United States
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Sacramento, California, 95825, United States
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San Diego, California, 92108, United States
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San Leandro, California, 94578, United States
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Santa Barbara, California, 93108, United States
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Santa Maria, California, 93454, United States
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Sherman Oaks, California, 91423, United States
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Van Nuys, California, 91405, United States
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Victorville, California, 92295, United States
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Westlake Village, California, 91361, United States
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Whittier, California, 90606, United States
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Colorado Springs, Colorado, 80910, United States
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Denver, Colorado, 80230, United States
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Bridgeport, Connecticut, 06606, United States
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Danbury, Connecticut, 06810, United States
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Hamden, Connecticut, 06518, United States
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Trumbull, Connecticut, 06611, United States
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Lewes, Delaware, 19958, United States
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Aventura, Florida, 33180, United States
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Boca Raton, Florida, 33486, United States
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Clearwater, Florida, 33761, United States
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Dunedin, Florida, 34698, United States
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Fort Lauderdale, Florida, 33334, United States
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Gainesville, Florida, 30501, United States
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Gainesville, Florida, 32608, United States
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Jacksonville, Florida, 32209, United States
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Lake Mary, Florida, 32746, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33133, United States
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Naples, Florida, 34102, United States
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Ocala, Florida, 34474, United States
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Orlando, Florida, 32806, United States
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Palm Harbor, Florida, 34684, United States
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Sarasota, Florida, 34239, United States
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South Miami, Florida, 33143, United States
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St. Petersburg, Florida, 33710, United States
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Tampa, Florida, 33614, United States
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Tampa, Florida, 33618, United States
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Atlanta, Georgia, 30342, United States
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Gainesville, Georgia, 30501, United States
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Boise, Idaho, 83702, United States
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Idaho Falls, Idaho, 83404, United States
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Nampa, Idaho, 83686, United States
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Chicago, Illinois, 60616, United States
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Maywood, Illinois, 60153, United States
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Moline, Illinois, 61265, United States
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Morton Grove, Illinois, 60053, United States
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Peoria, Illinois, 61602, United States
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Schaumburg, Illinois, 60195, United States
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Springfield, Illinois, 62704, United States
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Vernon Hills, Illinois, 60061, United States
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Evansville, Indiana, 47714, United States
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Fort Wayne, Indiana, 46804, United States
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South Bend, Indiana, 46601, United States
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Cedar Rapids, Iowa, 52401, United States
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Lees Summit, Kansas, 64086, United States
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Wichita, Kansas, 67208, United States
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Lexington, Kentucky, 40515, United States
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Baton Rouge, Louisiana, 70808, United States
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Baton Rouge, Louisiana, 70810, United States
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Monroe, Louisiana, 71203, United States
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New Orleans, Louisiana, 70121, United States
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Columbia, Maryland, 21045, United States
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Ellicott City, Maryland, 21042, United States
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Frederick, Maryland, 21702, United States
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Wheaton, Maryland, 20902, United States
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Boston, Massachusetts, 02115, United States
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Fall River, Massachusetts, 02720, United States
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Pascagoula, Massachusetts, 39581, United States
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Peabody, Massachusetts, 01960, United States
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Plymouth, Massachusetts, 02360, United States
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Worcester, Massachusetts, 01605, United States
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Worcester, Massachusetts, 01610, United States
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Battle Creek, Michigan, 49015, United States
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Kalamazoo, Michigan, 49048, United States
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Lansing, Michigan, 48910, United States
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Petoskey, Michigan, 49770, United States
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Saint Clair Shores, Michigan, 48080, United States
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Duluth, Minnesota, 55805, United States
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Eagan, Minnesota, 55121, United States
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Edina, Minnesota, 55435, United States
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Saint Louis Park, Minnesota, 55426, United States
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Flowood, Mississippi, 39232, United States
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Hattiesburg, Mississippi, 39402, United States
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Jackson, Mississippi, 39202, United States
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Tupelo, Mississippi, 38802, United States
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Florissant, Missouri, 63031, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63128, United States
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St Louis, Missouri, 63141, United States
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Kalispell, Montana, 59901, United States
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Grand Island, Nebraska, 68803, United States
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Lincoln, Nebraska, 68516, United States
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Reno, Nevada, 89502, United States
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Dover, New Hampshire, 03820, United States
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Lebanon, New Hampshire, 03756, United States
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Clifton, New Jersey, 07012, United States
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Haddon Heights, New Jersey, 08035, United States
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Manalapan, New Jersey, 07726, United States
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Morristown, New Jersey, 07962, United States
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New Brunswick, New Jersey, 08903, United States
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Trenton, New Jersey, 08360, United States
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Voorhees Township, New Jersey, 08043, United States
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Las Cruces, New Mexico, 88011, United States
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Albany, New York, 12206, United States
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Binghamton, New York, 13905, United States
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Brooklyn, New York, 11201, United States
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Cooperstown, New York, 13326, United States
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Hewlett, New York, 11557, United States
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Lake Success, New York, 11042, United States
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New York, New York, 10016, United States
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Olean, New York, 14760, United States
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Orchard Park, New York, 14127, United States
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Plainview, New York, 11803, United States
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Rochester, New York, 14618, United States
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Roslyn, New York, 11576, United States
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Smithtown, New York, 11787, United States
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Syracuse, New York, 13210, United States
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Utica, New York, 13504, United States
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Asheville, North Carolina, 28803, United States
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Belmont, North Carolina, 28012, United States
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Charlotte, North Carolina, 28204, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28210, United States
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Durham, North Carolina, 27704, United States
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Greenville, North Carolina, 27834, United States
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Raleigh, North Carolina, 27609, United States
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Rock Hill, North Carolina, 29732, United States
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Wilmington, North Carolina, 28401, United States
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Bismarck, North Dakota, 58501, United States
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Akron, Ohio, 44333, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45255, United States
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Columbus, Ohio, 43210, United States
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Columbus, Ohio, 43215, United States
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Dayton, Ohio, 45402, United States
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Gallipolis, Ohio, 45631, United States
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Mayfield, Ohio, 44143, United States
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Middleburg Heights, Ohio, 44130, United States
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Perryburg, Ohio, 43551, United States
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Zanesville, Ohio, 43701, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73109, United States
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Tulsa, Oklahoma, 74135, United States
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Lake Oswego, Oregon, 97035, United States
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Bethlehem, Pennsylvania, 18015, United States
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Camp Hill, Pennsylvania, 17011, United States
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Duncansville, Pennsylvania, 16635, United States
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Lebanon, Pennsylvania, 17042, United States
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Philadelphia, Pennsylvania, 19141, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pottstown, Pennsylvania, 19464, United States
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West Reading, Pennsylvania, 19611, United States
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Wexford, Pennsylvania, 15090, United States
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Willow Grove, Pennsylvania, 19090, United States
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Charleston, South Carolina, 29406, United States
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Columbia, South Carolina, 29204, United States
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Hickory Grove, South Carolina, 28602, United States
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Myrtle Beach, South Carolina, 29572, United States
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Hendersonville, Tennessee, 37073, United States
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Hixson, Tennessee, 37343, United States
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Jackson, Tennessee, 38305, United States
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Knoxville, Tennessee, 37909, United States
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Nashville, Tennessee, 37027, United States
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Amarillo, Texas, 79106, United States
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Amarillo, Texas, 79124, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78749, United States
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Carrollton, Texas, 75007, United States
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Dallas, Texas, 75231-4406, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76107, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77090, United States
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Lubbock, Texas, 79424, United States
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Mesquite, Texas, 75150, United States
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Nassau Bay, Texas, 77058, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Tyler, Texas, 75701, United States
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Waco, Texas, 76708, United States
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Burlington, Vermont, 05401, United States
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Arlington, Virginia, 22205, United States
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Burke, Virginia, 22015, United States
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Richmond, Virginia, 23294, United States
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Virginia Beach, Virginia, 23454, United States
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Olympia, Washington, 98502, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Beckley, West Virginia, 25801, United States
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Clarksburg, West Virginia, 26301, United States
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Brookfield, Wisconsin, 53045, United States
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Franklin, Wisconsin, 53132, United States
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Glendale, Wisconsin, 53217, United States
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Milwaukee, Wisconsin, 53209, United States
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Onalaska, Wisconsin, 54605, United States
Related Publications (1)
Weinblatt ME, Kremer J, Cush J, Rigby W, Teng LL, Devenport J, Singh N, Lepley D, Genovese MC. Tocilizumab as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs: twenty-four-week results of an open-label, clinical practice study. Arthritis Care Res (Hoboken). 2013 Mar;65(3):362-71. doi: 10.1002/acr.21847.
PMID: 22972745DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2009
First Posted
April 30, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2010
Study Completion
March 1, 2011
Last Updated
October 25, 2012
Results First Posted
April 17, 2012
Record last verified: 2012-10