Status:
COMPLETED
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Clalit Health Services
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate respo...
Eligibility Criteria
Inclusion
- Adult patients, \>/=18 years of age
- Active moderate to severe rheumatoid arthritis
- Inadequate response to \>/=3 DMARDs (non-biologic and/or biologic)
- Current treatment at stable dose for \>/=8 weeks
- Etanercept discontinued \>/=2 weeks, Anakinra \>/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab \>/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab \>/=16 weeks, and must have proven B-cell repletion
Exclusion
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- Rheumatic autoimmune disease other than RA
- Functional class IV (American College of Rheumatology Classification)
- Prior history or current inflammatory joint disease other than RA
- Oral corticosteroids at a dose of \>10 mg/day prednisone equivalent
- Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
- Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
- History of or currently active primary or secondary immunodeficiency
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01149057
Start Date
October 1 2010
End Date
July 1 2014
Last Update
November 2 2016
Active Locations (16)
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1
Afula, Israel, 18101
2
Ashkelon, Israel, 78306
3
Beer Yaakov, Israel, 6093000
4
Beersheba, Israel, 8410101