Status:
COMPLETED
A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the no...
Eligibility Criteria
Inclusion
- Adult patients, at least 18 years of age, inclusive
- Diagnosis of rheumatoid arthritis of at least 6 months duration
- Moderate to severe active rheumatoid arthritis (DAS28 \>/=3.2)
- Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or more TNFalfa-inhibitors over a period of at least 8 weeks
Exclusion
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Functional class IV (ACR criteria)
- History of severe allergic reaction to human, humanized or murine monoclonal antibodies
- Known active current or history of recurrent infection (including tuberculosis)
- Primary or secondary immunodeficiency (history of or currently active)
- Body weight \>150 kg
- Previous treatment with any cell-depleting therapies
- Previous treatment with tocilizumab
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01468077
Start Date
November 1 2011
End Date
September 1 2013
Last Update
August 17 2015
Active Locations (8)
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1
Aalborg, Denmark, 9000
2
Frederiksberg, Denmark, 2000
3
Hellerup, Denmark, 2900
4
Holbæk, Denmark, 4300