Status:
COMPLETED
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.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rh...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- 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- Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug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
- Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01195272
Start Date
August 1 2010
End Date
March 1 2012
Last Update
November 13 2014
Active Locations (1)
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1
Liverpool, United Kingdom, L9 7AL