Status:
COMPLETED
An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in pati...
Eligibility Criteria
Inclusion
- Adult patients \>/=18 years of age
- Moderate to severe rheumatoid arthritis defined as DAS 28\>3.2
- Body weight \</=150 kg
- Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
- Inadequate clinical response to a stable dose of a non-biologic DMARD
Exclusion
- Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
- Functional class IV as defined by the ACR classification
- History or current inflammatory joint disease other than RA
- Previous treatment with any cell depleting therapy
- Previous treatment with methotrexate
- Previous treatment with tocilizumab
- Previous treatment with any biologic drug that is used in the treatment of RA
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01254331
Start Date
February 1 2011
End Date
February 1 2013
Last Update
February 26 2015
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Sfax, Tunisia, 3000
2
Sousse, Tunisia, 4000
3
Tunis, Tunisia, 1007
4
Tunis, Tunisia, 1008