An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies
1 other identifier
interventional
2,067
33 countries
293
Brief Summary
This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.
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 Sep 2005
Longer than P75 for phase_3 rheumatoid-arthritis
293 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
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 22, 2008
CompletedFirst Posted
Study publicly available on registry
July 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
September 30, 2014
CompletedSeptember 30, 2014
September 1, 2014
7.6 years
July 22, 2008
June 10, 2014
September 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With ≥ 1 Adverse Event
Baseline to the end of the study (up to 7 years, 7 months)
Secondary Outcomes (15)
Percentage of Participants Who Withdrew From Treatment
Baseline to the end of the study (up to 7 years, 7 months)
Percentage of Participants With Concomitant Oral Corticosteroid Therapy
Baseline to the end of the study (up to 7 years, 7 months)
Percentage of Participants Who Changed From Monotherapy to Combination Therapy
Baseline to Week 296
Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264
Baseline to Week 264
Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
Baseline to Week 264
- +10 more secondary outcomes
Study Arms (1)
Tocilizumab
EXPERIMENTALParticipants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Interventions
For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.
Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.
Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.
Oral corticosteroids (≤ 10 mg/day) were permitted during the study.
Eligibility Criteria
You may qualify if:
- Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.
You may not qualify if:
- Treatment with any investigational agent since the last administration of study drug in the core studies.
- Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
- Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
- Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
- Previous treatment with any cell-depleting therapies, including investigational agents.
- Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (295)
Unknown Facility
Birmingham, Alabama, 35294-7201, United States
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Huntsville, Alabama, 35801, United States
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Mesa, Arizona, 85208, 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, 85723, United States
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Tucson, Arizona, 85724, United States
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Little Rock, Arkansas, 72205, United States
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Anaheim, California, 92801, United States
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Long Beach, California, 90806, United States
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Long Beach, California, 90808, United States
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Los Angeles, California, 90045, United States
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Los Angeles, California, 90095, United States
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Palm Desert, California, 92260, United States
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Palm Springs, California, 92262, United States
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Palo Alto, California, 94304, United States
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San Diego, California, 92101, United States
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San Diego, California, 92108, United States
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San Jose, California, 95126, United States
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San Leandro, California, 94578, United States
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Santa Maria, California, 93454, United States
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Torrance, California, 90505, United States
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Upland, California, 91786, United States
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Colorado Springs, Colorado, 80910, United States
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Newark, Delaware, 19713, United States
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Aventura, Florida, 33180, United States
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Delray Beach, Florida, 33484, United States
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Fort Lauderdale, Florida, 33334, United States
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Palm Habor, Florida, 34684, 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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Tampa, Florida, 33609, United States
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Tampa, Florida, 33614, United States
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West Palm Beach, Florida, 33407, United States
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Atlanta, Georgia, 30342, 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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Meridian, Idaho, 83642, United States
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Morton Grove, Illinois, 60053, 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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Indianapolis, Indiana, 46202-5149, United States
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Cedar Rapids, Iowa, 52401, United States
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Des Moines, Iowa, 50322, United States
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Bowling Green, Kentucky, 42102, United States
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Lexington, Kentucky, 40515, United States
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Louisville, Kentucky, 40202, United States
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Baton Rouge, Louisiana, 70808, United States
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Shreverport, Louisiana, 71103, United States
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Slidell, Louisiana, 70458, United States
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Portland, Maine, 04102, 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, 02111, United States
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Pittsfield, Massachusetts, 01201, United States
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Grand Rapids, Michigan, 49546, United States
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Kalamazoo, Michigan, 49048, United States
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Lansing, Michigan, 48910, United States
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Eagan, Minnesota, 55121, United States
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Saint Cloud, Minnesota, 56303, 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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Tupelo, Mississippi, 38802, United States
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Springfield, Missouri, 65807, 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, 63131, United States
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St Louis, Missouri, 63141, United States
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Billings, Montana, 59107-5100, 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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Haddon Heights, New Jersey, 08035, United States
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New Brunswick, New Jersey, 08903, United States
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Passaic, New Jersey, 07055, United States
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Albuquerque, New Mexico, 87131, 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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Great Neck, New York, 11020, United States
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New York, New York, 10021, 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, 14642, United States
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Syracuse, New York, 13210, United States
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Asheville, North Carolina, 28803, United States
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Chapel Hill, North Carolina, 27599-7280, 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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Raleigh, North Carolina, 27609, United States
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Bismarck, North Dakota, 58501, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45219, United States
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Cleveland, Ohio, 44109, United States
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Dayton, Ohio, 45408, 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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Oklahoma City, Oklahoma, 73112, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, 74135, United States
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Eugene, Oregon, 97401, United States
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Medford, Oregon, 97504, United States
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Allentown, Pennsylvania, 18103, United States
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Bethlehem, Pennsylvania, 18015, United States
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Danville, Pennsylvania, 17822, United States
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Duncansville, Pennsylvania, 16635, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pittsburgh, Pennsylvania, 15261, United States
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Willow Grove, Pennsylvania, 19090, United States
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Willow Grove, Pennsylvania, 80045, United States
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Wyomissing, Pennsylvania, 19610, United States
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Johnston, Rhode Island, 02919, 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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Greenville, South Carolina, 29601, United States
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Hickory Grove, South Carolina, 28602, United States
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Hixson, Tennessee, 37343, United States
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Jackson, Tennessee, 38305, United States
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Nashville, Tennessee, 37203, 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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Dallas, Texas, 75231-4406, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77074, United States
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Mesquite, Texas, 75150, United States
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Burlington, Vermont, 05401, United States
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Chesapeake, Virginia, 23320, United States
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Norfolk, Virginia, 23502, United States
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Mountlake Terrace, Washington, 98043, United States
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Olympia, Washington, 98502, United States
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Seattle, Washington, 98104, United States
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Seattle, Washington, 98195, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Glendale, Wisconsin, 53217, United States
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La Crosse, Wisconsin, 54601, United States
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Buenos Aires, C1015ABO, Argentina
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Buenos Aires, C1428DQG, Argentina
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Rosario, S2000PBJ, Argentina
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San Juan Bautista, B1878DVB, Argentina
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Hobart, 7000, Australia
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Malvern, 3144, Australia
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Shenton Park, 6008, Australia
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Sydney, 2050, Australia
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Woolloongabba, 4102, Australia
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Hasselt, 3500, Belgium
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Merksem, 2170, Belgium
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Campinas, 13060-803, Brazil
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Goiânia, 74653-050, Brazil
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Rio de Janeiro, 20551030, Brazil
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Calgary, Alberta, T2V 1P9, Canada
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Edmonton, Alberta, T5H 3V9, Canada
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Victoria, British Columbia, V8V 3P9, Canada
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Winnipeg, Manitoba, R3A 1M3, Canada
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St. John's, Newfoundland and Labrador, A1A 5E8, Canada
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Burlington, Ontario, L7R 1E2, Canada
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Hamilton, Ontario, L8N 2B6, Canada
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Kitchener, Ontario, N2M 5N6, Canada
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London, Ontario, N6A 4V2, Canada
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Mississauga, Ontario, L5M 2V8, Canada
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Ottawa, Ontario, K1H 1A2, Canada
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Toronto, Ontario, M5T 3L9, Canada
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Montreal, Quebec, H2L 1S6, Canada
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Québec, Quebec, G1V 3M7, Canada
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Sainte-Foy, Quebec, G1W 4R4, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Beijing, 100032, China
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Beijing, 100044, China
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Guangzhou, 510630, China
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Hefei Anhui, 230022, China
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Jinan, 250012, China
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Shanghai, 200127, China
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Shanghai, 200433, China
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San José, 10103, Costa Rica
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Hradec Králové, 500 05, Czechia
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Prague, 128 50, Czechia
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Prague, 140 59, Czechia
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Hellerup, 2900, Denmark
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Helsinki, 00290, Finland
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Jyväskylä, 40620, Finland
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Amiens, 80054, France
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Bordeaux, 33076, France
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Boulogne-Billancourt, 92104, France
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Brest, 29609, France
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Grenoble, 38042, France
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Le Kremlin-Bicêtre, 94270, France
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Lille, 59037, France
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Lyon, 69437, France
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Marseille, 13285, France
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Montpellier, 34295, France
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Nantes, 44035, France
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Nice, 06202, France
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Paris, 75181, France
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Paris, 75679, France
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Pierre-Bénite, 69495, France
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Rennes, 35203, France
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Rouen, 76031, France
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Saint-Priest-en-Jarez, 42277, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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Aachen, 52064, Germany
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Berlin, 10117, Germany
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Cologne, 50924, Germany
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Dresden, 01067, Germany
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Essen, 45239, Germany
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Gommern, 39245, Germany
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Herne, 44652, Germany
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Hildesheim, 31134, Germany
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München, 80335, Germany
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München, 81541, Germany
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Osnabrück, 49074, Germany
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Sendenhorst, 48324, Germany
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Wiesbaden, 65191, Germany
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Würzburg, 97080, Germany
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Hong Kong, 852, Hong Kong
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Tuenmen, 852, Hong Kong
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Reykjavik, 108, Iceland
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Ashkelon, 78306, Israel
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Haifa, 31048, Israel
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Haifa, 34354, Israel
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Rishon LeZiyyon, 70300, Israel
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Brescia, 25123, Italy
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Genova, 16132, Italy
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Milan, 20157, Italy
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Padua, 35128, Italy
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Pavia, 27100, Italy
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Pisa, 56100, Italy
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Siena, 53100, Italy
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Udine, 33100, Italy
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Kaunas, 50009, Lithuania
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Klaipėda, 92288, Lithuania
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Panevezys, 35144, Lithuania
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Šiauliai, 76231, Lithuania
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Vilnius, LT-08661, Lithuania
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Guadalajara, 44340, Mexico
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Guadalajara, 44620, Mexico
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Guadalajara, 45235, Mexico
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León, 37000, Mexico
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Mexico City, 06700, Mexico
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Mexico City, 07760, Mexico
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Mexico City, 14050, Mexico
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Tijuana, 22320, Mexico
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Nijmegen, 6525 GA, Netherlands
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Levanger, 7600, Norway
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Lillehammer, 2609, Norway
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Panama City, 32400, Panama
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Lima, 11, Peru
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Lima, 13, Peru
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Lisbon, 1349-019, Portugal
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Ponce, 00716, Puerto Rico
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Moscow, 105203, Russia
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Moscow, 115522, Russia
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Moscow, 117049, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 190068, Russia
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Saint Petersburg, 191015, Russia
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Tula, 300053, Russia
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Belgrade, 11000, Serbia
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Niška Banja, 18250, Serbia
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Ljubljana, 1000, Slovenia
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Maribor, 2000, Slovenia
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Cape Town, 4001, South Africa
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Cape Town, 7500, South Africa
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Diepkloof, 1862, South Africa
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Durban, 4001, South Africa
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Pinelands, 7405, South Africa
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Pretoria, 0002, South Africa
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Radiokop, 2040, South Africa
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Barakaldo, 48903, Spain
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Barcelona, 08035, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Pontevedra, 36001, Spain
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Santiago de Compostela, 15706, Spain
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Stockholm, 17176, Sweden
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Umeå, 90185, Sweden
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Lausanne, 1011, Switzerland
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Basingstoke, RG24 9NA, United Kingdom
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Birmingham, B29 6JD, United Kingdom
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Cannock, WS11 5XY, United Kingdom
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Derby, DE1 2QY, United Kingdom
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Leeds, LS7 4SA, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Manchester, M41 5SL, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
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Oxford, OX3 7LD, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Stoke-on-Trent, ST6 7AG, United Kingdom
Related Publications (1)
Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.
PMID: 27909081DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2008
First Posted
July 23, 2008
Study Start
September 1, 2005
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 30, 2014
Results First Posted
September 30, 2014
Record last verified: 2014-09