At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 227 enrolled
Drug / intervention
Tocilizumab +1 moredrug
Likely dose
Tocilizumab 162 mgfrom 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.
A National, Open-Label, Single-Arm, Phase IIIb Study to Evaluate the Efficacy of Weekly Tocilizumab Subcutaneous, Administered as Monotherapy or in Combination With Methotrexate and/or Other DMARDs in Rheumatoid Arthritis (RA) Patients
In Brief
A Phase 3 clinical trial evaluating Tocilizumab and DMARDs for Rheumatoid Arthritis. Completed, enrolled 227 participants across 49 sites.
Detailed Summary
This open-label, single arm, Phase 3b study will evaluate the efficacy of tocilizumab (RoActemra), administered as monotherapy or in combination with methotrexate and/or other DMARDs, in participants with moderate to severe active RA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedSep 2013
Primary CompletionSep 2015
Study CompletionJul 2016
TodayJul 2026
First PostedSep 13, 2013
Enrollment StartSep 5, 2013
Primary CompletionSep 9, 2015
Study CompletionJul 5, 2016
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.8 years ago
Interventions
Tocilizumabdrug
Tocilizumab at a fixed dose of 162 mg as SC injection will be administered once every week.
DMARDsdrug
Non-biologic DMARDs according to standard of care, at a stable dose that was initiated at least 4 weeks prior to baseline.