At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 471 enrolled
Drug / intervention
CT-P47 +1 morebiological
Likely dose
CT-P47 8 mg/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.
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating CT-P47 and EU-approved RoActemra for Rheumatoid Arthritis. Completed, enrolled 471 participants across 1 site.
Detailed Summary
This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesPoland
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartSep 2022
Primary CompletionJun 2023
Study CompletionNov 2023
TodayJul 2026
First PostedAug 5, 2022
Enrollment StartSep 14, 2022
Primary CompletionJun 29, 2023
Study CompletionNov 23, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.9 years ago
Interventions
CT-P47biological
CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)
EU-approved RoActemrabiological
EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W