Status:
COMPLETED
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who ...
Eligibility Criteria
Inclusion
- adults 18 - 75 years of age
- active rheumatoid arthritis of \>/= 6 months duration
- inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
- swollen joint count (SJC)\>/=4, tender joint count (TJC)\>/=6 at screening and baseline
- DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
- oral corticosteroids (\</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose \</= 4 weeks prior to baseline
Exclusion
- rheumatic autoimmune disease other than rheumatoid arthritis
- prior history or current inflammatory joint disease other than rheumatoid arthritis
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- functional class IV by ACR classification
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00965653
Start Date
August 1 2009
End Date
July 1 2011
Last Update
November 2 2016
Active Locations (7)
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1
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
2
Kitchener, Ontario, Canada, N2M 5N6
3
Trois-Rivières, Quebec, Canada, G8Z 1Y2
4
Christchurch, New Zealand, 8011