A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT01245439
Last Updated: 2015-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
65 participants
INTERVENTIONAL
2011-09-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Interventions
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tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe active rheumatoid arthritis (DAS28\>/=3.2) of \>/=6 months duration
* Body weight \</=150 kg
* Patients are on one or more non-biologic DMARDs at a stable dose for a period \>/=8 weeks prior to study treatment
* Patients with inadequate clinical response to a stable dose of non-biologic DMARD
Exclusion Criteria
* Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis
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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Adana, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Aydin, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Denizli, , Turkey (Türkiye)
Elâzığ, , Turkey (Türkiye)
Gaziantep, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
İzmit, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
Manisa, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Sivas, , Turkey (Türkiye)
Countries
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Other Identifiers
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ML25095
Identifier Type: -
Identifier Source: org_study_id
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