A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.
NCT ID: NCT01195272
Last Updated: 2014-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
21 participants
INTERVENTIONAL
2010-08-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 52 weeks
Interventions
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tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 52 weeks
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe active rheumatoid arthritis of \>/= 6 months duration
* DAS28 \>/= 3.2 at screening and baseline
* Inadequate response to biologic or non-biologic DMARDs
* Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug
* If continuing on a non-biologic DMARD, dose should be stable for at least 8 weeks
* Oral corticosteroids must have been at stable dose for at least 25 out of 28 days prior to baseline
Exclusion Criteria
* Rheumatic autoimmune disease other then RA
* Functional class IV as defined by the American College of Rheumatology (ACR) classification
* Prior history of or current inflammatory joint disease other than RA
* Previous treatment with any cell-depleting therapies
* Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
* Active infection or history of recurrent infection
* Positive for HIV or hepatitis B or C
* History of or current primary or secondary immunodeficiency
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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Liverpool, , United Kingdom
Countries
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Other Identifiers
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2010-018331-18
Identifier Type: -
Identifier Source: secondary_id
ML25243
Identifier Type: -
Identifier Source: org_study_id