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A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis - NCT01007435-53217(Clinical Trial 399280)



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City:  Glendale
State:  
WI
Zip Code: 53217
Conditions: Rheumatoid Arthritis
Purpose: This randomized, double-blind, parallel group study will assess the safety, disease remission and prevention of structural joint damage on treatment with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate in patients with early moderate to severe rheumatoid arthritis. Patients will be randomized to receive either A) tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or B) tocilizumab (8mg/kg iv every 4 weeks) plus methotrexate (7.5-20mg po weekly), or C) tocilizumab (4mg/kg iv every 4 weeks) plus methotrexate (7.5-20mg po weekly), or D) placebo plus methotrexate (7.5-20mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks and target sample size is >1'000 individuals
Study summary:
Criteria: Inclusion Criteria: - adult patients, >/=18 years of age - rheumatoid arthritis of </=2 years duration - DAS28 >3.2 - SJC >/=4, TJC >/=6 - RF and/or anti-CCP positive (if RF and anti-CCP negative >1 erosion required at screening) - ESR >/=28mm/h or CRP >/=10mg/L at screening Exclusion Criteria: - previous treatment with tocilizumab - previous treatment with methotrexate or biologic agent - rheumatic autoimmune disease other than RA - history of or current inflammatory joint disease other than RA - functional class IV
Study is available at:
Glendale, WI 53217
United States

Primary Contact:
Please reference Study ID Number: WA19926
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only)
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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