Status:
COMPLETED
A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih 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 effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 wee...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- rheumatoid arthritis of \>=6 months duration diagnosed according to the revised 1987 ACR criteria;
- DAS28 of \>3.2;
- At screening either ESR \>=28 mm/h or CRP \>=1 mg/dL;
- Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Exclusion
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
- functional class IV as identified by the ACR classification of functional status in RA;
- rheumatoid autoimmune disease other than RA;
- prior history of or current inflammatory joint disease other than RA.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00754559
Start Date
August 1 2008
End Date
November 1 2009
Last Update
February 8 2016
Active Locations (81)
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1
Aachen, Germany, 52064
2
Bad Abbach, Germany, 93077
3
Bad Aibling, Germany, 83043
4
Bad Bramstedt, Germany, 24576