Status:
COMPLETED
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMA...
Eligibility Criteria
Inclusion
- male and non-pregnant or nursing female patients \>=18 years of age;
- body weight \<=150kg;
- moderate to severe active RA (DAS28 \>=3.2) of \>=6 months duration;
- on \>=1 non-biologic DMARDs at a stable dose for a period of \>= 8 weeks prior to start of treatment;
- inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
- if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
Exclusion
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
- rheumatic autoimmune disease other than RA;
- prior history of, or current inflammatory joint disease other than RA;
- functional class IV as defined by the ACR Classification of Functional Status in RA.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
1681 Patients enrolled
Trial Details
Trial ID
NCT00750880
Start Date
September 1 2008
End Date
July 1 2011
Last Update
July 22 2015
Active Locations (282)
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1
Canberra, Australian Capital Territory, Australia, 2601
2
Coffs Harbour, New South Wales, Australia, 2450
3
Kogarah, New South Wales, Australia, 2217
4
Parramatta Park, New South Wales, Australia, 4870