At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 14 enrolled
Drug / intervention
tocilizumab [RoActemra/Actemra]drug
Likely dose
tocilizumab [RoActemra/Actemra] 8mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.
In Brief
A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Rheumatoid Arthritis. Completed, enrolled 14 participants across 3 sites.
Detailed Summary
This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesFinland
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedDec 2008
Primary CompletionMay 2010
TodayJul 2026
First PostedDec 18, 2008
Enrollment StartNov 30, 2008
Primary CompletionMay 26, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.5 years ago
Interventions
tocilizumab [RoActemra/Actemra]drug
8mg/kg iv every 4 weeks for 24 weeks