A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01232569
First received: November 1, 2010
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of RoActemra/Actemra (tocilizumab) in combination with traditional disease-modifying antirheumatic drugs (DMARDs) in patients with active moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg RoActemra/Actemra or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg RoActemra/Actemra subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an autoinjector.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Parallel Group Study of the Safety and the Effect on Clinical Outcome of Tocilizumab SC Versus Placebo SC in Combination With Traditional Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Tocilizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Reduction in disease activity according to American College of Rheumatology (ACR) 20 criteria [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Safety (incidence of adverse events) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Prevention of progression of structural damage [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Improvement of physical function [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Pharmacokinetics (change in RoActemra/Actemra serum levels) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Pharmacodynamics (interleukin levels) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Immunogenicity of RoActemra/Actemra [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 656 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A1 |
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously using a pre-filled syringe every two weeks for 24 weeks
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously using an autoinjector every 2 weeks from week 24 to week 96
|
| Experimental: A2 |
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously using a pre-filled syringe every two weeks for 24 weeks
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously using a pre-filled syringe every 2 weeks from week 24 to week 96
|
| Placebo Comparator: B1 |
Drug: placebo
subcutaneously using a pre-filled syringe every two weeks for 24 weeks
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously using an autoinjector every 2 weeks from week 24 to week 96
|
| Placebo Comparator: B2 |
Drug: placebo
subcutaneously using a pre-filled syringe every two weeks for 24 weeks
Drug: tocilizumab [RoActemra/Actemra]
162 mg subcutaneously using a pre-filled syringe every 2 weeks from week 24 to week 96
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Moderate to severe rheumatoid arthritis of >/=6 months duration
- Receiving treatment on an outpatient basis
- Swollen joint count (SJC) >/=6 (66 joint count) and tender joint count (TJC) >/=8 (68 joint count) at screening and study start
- On a stable dose of disease-modifying antirheumatic drugs for at least 8 weeks prior to study start
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's syndrome with rheumatoid arthritis is allowed
- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232569
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Hide Study LocationsLocations
| United States, Arizona | |
| Peoria, Arizona, United States, 85381 | |
| Scottsdale, Arizona, United States, 85258 | |
| Tucson, Arizona, United States, 85723 | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Fullerton, California, United States, 92835 | |
| San Diego, California, United States, 92108 | |
| San Leandro, California, United States, 94578 | |
| West Hills, California, United States, 91307 | |
| United States, Connecticut | |
| Trumbull, Connecticut, United States, 06611 | |
| United States, Florida | |
| Boca Raton, Florida, United States, 33486 | |
| Jupiter, Florida, United States, 33458 | |
| Ormond Beach, Florida, United States, 32174 | |
| Sarasota, Florida, United States, 34292 | |
| United States, Georgia | |
| Gainesville, Georgia, United States, 30501 | |
| United States, Idaho | |
| Idaho Falls, Idaho, United States, 83404 | |
| Meridan, Idaho, United States, 83642 | |
| United States, Illinois | |
| Springfield, Illinois, United States, 62704 | |
| Vernon Hills, Illinois, United States, 60061 | |
| United States, Maryland | |
| Crofton, Maryland, United States, 21114 | |
| Hagerstown, Maryland, United States, 21740 | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Mississippi | |
| Flowood, Mississippi, United States, 39232 | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Saint Louis, Missouri, United States, 63128 | |
| St Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Lincoln, Nebraska, United States, 68516 | |
| United States, New York | |
| Brooklyn, New York, United States, 11201 | |
| United States, North Carolina | |
| Belmont, North Carolina, United States, 28012 | |
| Charlotte, North Carolina, United States, 28211 | |
| Charlotte, North Carolina, United States, 28207 | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Allentown, Pennsylvania, United States, 18103 | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Wexford, Pennsylvania, United States, 15090 | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Dallas, Texas, United States, 75246 | |
| Fort Worth, Texas, United States, 76107 | |
| Houston, Texas, United States, 77034 | |
| Houston, Texas, United States, 77459 | |
| San Antonio, Texas, United States, 78232 | |
| United States, Washington | |
| Tacoma, Washington, United States, 98405 | |
| Argentina | |
| Buenos Aires, Argentina, C1015ABO | |
| Córdoba, Argentina, 5000 | |
| San Miguel de Tucuman, Argentina, 4000 | |
| Australia | |
| Cairns, Australia, 4870 | |
| Kogarah, Australia, 2217 | |
| Brazil | |
| Curitiba, Brazil, 80060-240 | |
| Goiania, Brazil, 74043-011 | |
| Juiz de Fora, Brazil, 36010-570 | |
| Porto Alegre, Brazil, 90610-000 | |
| Porto Alegre, Brazil, 91350-200 | |
| Rio de Janeiro, Brazil, 22271-100 | |
| Salvador, Brazil, 40050-410 | |
| Sao Paulo, Brazil, 5403900 | |
| Sao Paulo, Brazil, 04266-010 | |
| Sao Paulo, Brazil, 05437-010 | |
| São Paulo, Brazil, 1244030 | |
| São Paulo, Brazil, 04026-000 | |
| Vitoria, Brazil, 29055-450 | |
| Bulgaria | |
| Plovdiv, Bulgaria, 4002 | |
| Plovdiv, Bulgaria, 4003 | |
| Sofia, Bulgaria, 1612 | |
| Sofia, Bulgaria, 2233 | |
| Varna, Bulgaria, 9010 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3A 1M3 | |
| Winnipeg, Manitoba, Canada, R3N 0K6 | |
| Canada, Ontario | |
| London, Ontario, Canada, N6A 4V2 | |
| Ottawa, Ontario, Canada, K1H 1A2 | |
| Canada, Quebec | |
| Pointe-claire, Quebec, Canada, H9R 3J1 | |
| Colombia | |
| Bogota, Colombia | |
| Chia-cundinamarca, Colombia | |
| Medellin, Colombia | |
| Greece | |
| Athens, Greece, 15121 | |
| Athens, Greece, 11527 | |
| Thessaloniki, Greece, 54636 | |
| Guatemala | |
| Guatemala City, Guatemala, 01013 | |
| Guatemala City, Guatemala, 01015 | |
| Guatemala City, Guatemala, 01010 | |
| Hungary | |
| Budapest, Hungary, 1036 | |
| Debrecen, Hungary, 4004 | |
| Israel | |
| Ashkelon, Israel, 78306 | |
| Beer Sheva, Israel, 84101 | |
| Haifa, Israel, 31096 | |
| Haifa, Israel, 31048 | |
| Ramat Gan, Israel, 52621 | |
| Rishon Lezion, Israel | |
| Tel Aviv, Israel, 64239 | |
| Malaysia | |
| Batu Caves, Malaysia, 68100 | |
| Kota Kinabalu, Malaysia, 88586 | |
| Kuala Lumpur, Malaysia, 50603 | |
| Mexico | |
| Chihuahua, Mexico, 31000 | |
| Culiacan, Mexico, 80000 | |
| Guadalajara, Mexico, 44158 | |
| Leon, Mexico, 37320 | |
| Merida, Mexico, 97000 | |
| Mexicali, Mexico, 21100 | |
| Mexico, Mexico, 44620 | |
| Morelia, Mexico, 58070 | |
| Obregon, Mexico, 85000 | |
| Queretaro, Mexico, 76178 | |
| Queretaro, Mexico, 76000 | |
| New Zealand | |
| Otahuhu, New Zealand, 1006 | |
| Panama | |
| Panama City, Panama, 32400 | |
| Philippines | |
| Cebu, Philippines, 6000 | |
| Davao, Philippines, 8006 | |
| Manila, Philippines, 1780 | |
| Poland | |
| Bytom, Poland, 41902 | |
| Dzialdowo, Poland, 13-200 | |
| Elblag, Poland, 82-300 | |
| Koscian, Poland, 64-000 | |
| Krakow, Poland, 31-121 | |
| Torun, Poland, 87-100 | |
| Warszawa, Poland, 02-653 | |
| Russian Federation | |
| Kemerovo, Russian Federation, 650099 | |
| Moscow, Russian Federation, 115522 | |
| Moscow, Russian Federation, 129327 | |
| Moscow, Russian Federation, 117049 | |
| Novosibirsk, Russian Federation, 630099 | |
| Petrozavodsk, Russian Federation, 185019 | |
| Ryazan, Russian Federation, 390026 | |
| Saint-petersburg, Russian Federation, 197341 | |
| St Petersburg, Russian Federation, 197022 | |
| St Petersburg, Russian Federation, 190068 | |
| UFA, Russian Federation, 450005 | |
| Voronezh, Russian Federation, 394066 | |
| South Africa | |
| Durban, South Africa, 4013 | |
| Pinelands, South Africa, 7405 | |
| Pretoria, South Africa, 0002 | |
| Spain | |
| La Coruna, Spain, 15006 | |
| Oviedo, Spain, 33006 | |
| Sevilla, Spain, 41009 | |
| Switzerland | |
| Fribourg, Switzerland, 1708 | |
| Genève, Switzerland, 1211 | |
| Lausanne, Switzerland, 1011 | |
| Zürich, Switzerland, 8063 | |
| Thailand | |
| Bangkok, Thailand, 10700 | |
| Bangkok, Thailand, 10400 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01232569 History of Changes |
| Other Study ID Numbers: | NA25220, 2010-019912-18 |
| Study First Received: | November 1, 2010 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Antirheumatic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013