A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
NCT ID: NCT00965653
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2009-08-31
2011-07-31
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
NONE
Study Groups
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1
folic acid
\>/= 5 mg po weekly
methotrexate
7.5 - 25 mg weekly (oral or parenteral)
tocilizumab [RoActemra/Actemra]
162 mg sc weekly (QW)for 12 weeks
2
folic acid
\>/= 5 mg po weekly
methotrexate
7.5 - 25 mg weekly (oral or parenteral)
tocilizumab [RoActemra/Actemra]
162 mg sc every other week (Q2W) for 12 weeks
Interventions
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folic acid
\>/= 5 mg po weekly
methotrexate
7.5 - 25 mg weekly (oral or parenteral)
tocilizumab [RoActemra/Actemra]
162 mg sc weekly (QW)for 12 weeks
tocilizumab [RoActemra/Actemra]
162 mg sc every other week (Q2W) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* active rheumatoid arthritis of \>/= 6 months duration
* inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
* swollen joint count (SJC)\>/=4, tender joint count (TJC)\>/=6 at screening and baseline
* DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
* oral corticosteroids (\</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose \</= 4 weeks prior to baseline
Exclusion Criteria
* prior history or current inflammatory joint disease other than rheumatoid arthritis
* major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* functional class IV by ACR classification
18 Years
75 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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St. John's, Newfoundland and Labrador, Canada
Kitchener, Ontario, Canada
Trois-Rivières, Quebec, Canada
Christchurch, , New Zealand
A Coruña, La Coruña, Spain
Santiago de Compostela, La Coruña, Spain
Seville, Sevilla, Spain
Countries
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Other Identifiers
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2009-011349-18
Identifier Type: -
Identifier Source: secondary_id
NP22623
Identifier Type: -
Identifier Source: org_study_id