Status:
COMPLETED
A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate t...
Eligibility Criteria
Inclusion
- Adult patients, \>/=18 years of age
- Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study
- Patients successfully completed studies WA17823 and WA18696 in South Africa
- Body weight \<150 kg
Exclusion
- Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696
- Previous treatment with any cell depleting therapies
- Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01214733
Start Date
October 1 2010
End Date
May 1 2011
Last Update
December 2 2015
Active Locations (4)
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1
Cape Town, South Africa, 7405
2
Cape Town, South Africa, 7500
3
Cape Town, South Africa, 8001
4
Diepkloof, South Africa, 1862