A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NCT ID: NCT01399697
Last Updated: 2015-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
261 participants
INTERVENTIONAL
2011-09-30
2014-05-31
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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A
methotrexate
orally, Week 1 - 16
methotrexate
orally, Week 17-28
tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 28 weeks
B
methotrexate
orally, Week 1 - 16
placebo
methotrexate placebo orally, Week 17-28
tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 28 weeks
Interventions
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methotrexate
orally, Week 1 - 16
methotrexate
orally, Week 17-28
placebo
methotrexate placebo orally, Week 17-28
tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 28 weeks
Eligibility Criteria
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Inclusion Criteria
* Active moderate to severe rheumatoid arthritis (DAS28 \>/= 3.2) at baseline
* Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
* Body weight \< 150 kg
* Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day
Exclusion Criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
* Rheumatic autoimmune disease other than RA
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
* Prior history of or current inflammatory joint disease other than RA
* Treatment with a biologic agent at any time prior to baseline
* Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Known active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for HIV infection
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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Albacete, Albacete, Spain
Orihuela, Alicante, Spain
Torrevieja, Alicante, Spain
Villajoyosa, Alicante, Spain
Badajoz, Badajoz, Spain
Mérida, Badajoz, Spain
Menorca, Balearic Islands, Spain
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Granollers, Barcelona, Spain
Terrassa, Barcelona, Spain
Cáceres, Caceres, Spain
Cadiz, Cadiz, Spain
Torrelavega, Cantabria, Spain
Villarreal, Castellon, Spain
Córdoba, Cordoba, Spain
Granada, Granada, Spain
Granada, Granada, Spain
Guadalajara, Guadalajara, Spain
A Coruña, La Coruña, Spain
Santiago de Compostela, La Coruña, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
León, Leon, Spain
Lugo, Lugo, Spain
Alcalá de Henares, Madrid, Spain
Fuenlabrada, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Valdemoro, Madrid, Spain
Málaga, Malaga, Spain
Cartagena, Murcia, Spain
El Palmar, Murcia, Spain
Vigo, Pontevedra, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
Seville, Sevilla, Spain
Santa Cruz de Tenerife, Tenerife, Spain
Toledo, Toledo, Spain
Manises, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valenica, Valencia, Spain
Barakaldo, Vizcaya, Spain
Bilbao, Vizcaya, Spain
Galdakao, Vizcaya, Spain
Countries
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Other Identifiers
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ML27828
Identifier Type: -
Identifier Source: org_study_id
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