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Tocilizumab Extension Study in Rheumatoid Arthritis
NCT00883753Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2009
- Primary completion
- Apr 2012
- Countries
- 14
- Sponsor
- Roche
- Modality
- Antibody Conjugates, Recombinant Proteins and Enzymes, Engineered Antibody Formats
- Drugs
- tocilizumab
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, open-label, single-arm trial of tocilizumab in rheumatoid arthritis (RA), sponsored by Roche. Primary endpoint: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) at 108 weeks. Started Mar 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Tocilizumab
Tocilizumab 8 mg/kg IV every 4 weeks
03
Who it enrols
Patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.
04
Endpoints
Primary
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary
Percentage of Participants With Adverse Events Leading to Withdraw
Time to Withdrawal Due to an Adverse Event (AE)
Percentage of Participants With Discontinuation of Treatment Due to Any Cause
Percentage of Participants With Marked Lipid Abnormalities
Percentage of Participants With ALT Elevations > 3*ULN
Percentage of Participants With Clinically Meaningful Improvement in Disease Activity Score-28 (DAS28)
Percentage of Participants With DAS28 Low Disease Activity
Percentage of Participants With DAS28 Remission
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