Status:
COMPLETED
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthri...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Active moderate to severe rheumatoid arthritis (RA)
- On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
- Oral corticosteroids must have been at stable dose of \</= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
- Body weight \</= 150 kg
Exclusion
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
- Rheumatic autoimmune disease other than RA
- Functional class IV according to American College of Rheumatology (ACR) classification
- Prior history of or current inflammatory joint disease other then RA
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Treatment with any biologic drug that is used in the treatment or RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Positive for HIV
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01235507
Start Date
February 1 2011
End Date
December 1 2012
Last Update
November 7 2014
Active Locations (3)
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1
Banja Luka, Bosnia and Herzegovina, 78 000
2
Sarajevo, Bosnia and Herzegovina, 71000
3
Tuzla, Bosnia and Herzegovina, 75000