A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
NCT ID: NCT00106535
Last Updated: 2014-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1196 participants
INTERVENTIONAL
2005-01-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tocilizumab 4 mg/kg + Methotrexate
Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
tocilizumab [RoActemra/Actemra]
4 mg/kg or 8 mg/kg IV/month every 4 weeks.
Methotrexate
10-25 mg/week
Tocilizumab 8 mg/kg + Methotrexate
Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
tocilizumab [RoActemra/Actemra]
4 mg/kg or 8 mg/kg IV/month every 4 weeks.
Methotrexate
10-25 mg/week
Placebo + Methotrexate
Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with \< 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a \>70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
Placebo
IV/month
Methotrexate
10-25 mg/week
Interventions
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tocilizumab [RoActemra/Actemra]
4 mg/kg or 8 mg/kg IV/month every 4 weeks.
Placebo
IV/month
Methotrexate
10-25 mg/week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* inadequate response to a stable dose of MTX;
* patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria
* prior treatment failure with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
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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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Maria, California, United States
Torrance, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Aventura, Florida, United States
Fort Lauderdale, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Boise, Idaho, United States
Coeur d'Alene, Idaho, United States
Idaho Falls, Idaho, United States
Meridan, Idaho, United States
Chicago, Illinois, United States
Rockford, Illinois, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Frederick, Maryland, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Missoula, Montana, United States
Reno, Nevada, United States
Dover, New Hampshire, United States
Medford, New Jersey, United States
Voorhees Township, New Jersey, United States
Albany, New York, United States
Brooklyn, New York, United States
Lake Success, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Canton, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Bethlehem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Olympia, Washington, United States
Seattle, Washington, United States
Glendale, Wisconsin, United States
Adelaide, , Australia
Malvern, , Australia
Melbourne, , Australia
New Lambton, , Australia
Shenton Park, , Australia
St Leonards, , Australia
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Beijing, , China
Beijing, , China
Nanjing, , China
Shanghai, , China
Shanghai, , China
Hellerup, , Denmark
Odense, , Denmark
Heinola, , Finland
Helsinki, , Finland
Oulu, , Finland
Vantaa, , Finland
Amiens, , France
Bobigny, , France
Bois-Guillaume, , France
Bordeaux, , France
Le Kremlin-Bicêtre, , France
Lille, , France
Nice, , France
Orléans, , France
Paris, , France
Paris, , France
Strasbourg, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Athens, , Greece
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Brescia, , Italy
Coppito, , Italy
Florence, , Italy
Genova, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Padua, , Italy
Pavia, , Italy
Pisa, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Torino, , Italy
Udine, , Italy
Valeggio sul Mincio, , Italy
Varese, , Italy
Verona, , Italy
Chihuahua City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Obregón, , Mexico
Haugesund, , Norway
Lillehammer, , Norway
Tromsø, , Norway
Bydgoszcz, , Poland
Działdowo, , Poland
Elblag, , Poland
Kalisz, , Poland
Krakow, , Poland
Krakow, , Poland
Poznan, , Poland
Szczecin, , Poland
Ustroń, , Poland
Warsaw, , Poland
Warsaw, , Poland
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Cape Town, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Diepkloof, , South Africa
Barcelona, , Spain
Cadiz, , Spain
Mérida, , Spain
Sabadell, , Spain
Santander, , Spain
Seville, , Spain
Lausanne, , Switzerland
Sankt Gallen, , Switzerland
Countries
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References
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Khawaja MN, Bergman MJ, Yourish J, Pei J, Reiss W, Keystone E. Routine Assessment of Patient Index Data 3 and the American College of Rheumatology/European League Against Rheumatism Provisional Remission Definitions as Predictors of Radiographic Outcome in a Rheumatoid Arthritis Clinical Trial With Tocilizumab. Arthritis Care Res (Hoboken). 2017 May;69(5):609-615. doi: 10.1002/acr.23008. Epub 2017 Apr 7.
Kremer JM, Blanco R, Halland AM, Brzosko M, Burgos-Vargas R, Mela CM, Rowell L, Fleischmann RM. Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial. Clin Exp Rheumatol. 2016 Jul-Aug;34(4):625-33. Epub 2016 Apr 15.
Bay-Jensen AC, Platt A, Siebuhr AS, Christiansen C, Byrjalsen I, Karsdal MA. Early changes in blood-based joint tissue destruction biomarkers are predictive of response to tocilizumab in the LITHE study. Arthritis Res Ther. 2016 Jan 20;18:13. doi: 10.1186/s13075-015-0913-x.
Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.
Siebuhr AS, Bay-Jensen AC, Leeming DJ, Plat A, Byrjalsen I, Christiansen C, van de Heijde D, Karsdal MA. Serological identification of fast progressors of structural damage with rheumatoid arthritis. Arthritis Res Ther. 2013 Aug 14;15(4):R86. doi: 10.1186/ar4266.
Fleischmann RM, Halland AM, Brzosko M, Burgos-Vargas R, Mela C, Vernon E, Kremer JM. Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results. J Rheumatol. 2013 Feb;40(2):113-26. doi: 10.3899/jrheum.120447. Epub 2013 Jan 15.
Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.
Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, Ambs P, Fleischmann R. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011 Mar;63(3):609-21. doi: 10.1002/art.30158.
Other Identifiers
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WA17823
Identifier Type: -
Identifier Source: org_study_id
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