Status:
COMPLETED
A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid ...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- rheumatoid arthritis \>=6 months duration;
- DAS28\>=3.2;
- inadequate response to prior treatment with a stable dose (\>=8 weeks) of DMARD therapy.
Exclusion
- rheumatic autoimmune disease other than rheumatoid arthritis;
- history of or current inflammatory joint disease other than rheumatoid arthritis;
- unsuccessful treatment with an anti-TNF agent;
- previous/concurrent treatment with any cell-depleting therapies.
Key Trial Info
Start Date :
October 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00951275
Start Date
October 31 2009
End Date
July 22 2011
Last Update
August 3 2017
Active Locations (27)
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1
Ospedale Perrino; Medicina Interna - Divisione di Reumatologia
Brindisi, Apulia, Italy, 72100
2
Presidio Ospedaliero Valle D'itria; Divisione Di Nefrologia
Martina Franca, Apulia, Italy, 74015
3
Ospedale Galateo; U.O. Di Reumatologia
San Cesario di Lecce, Apulia, Italy, 73016
4
Azienda Ospedaliera Rummo; Divisione Di Reumatologia
Benevento, Campania, Italy, 82100