At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 621 enrolled
Drug / intervention
BAT1806 +1 moredrug
Likely dose
BAT1806 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, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
In Brief
A Phase 3 clinical trial evaluating BAT1806 and Actemra(EU-licensed) for Rheumatoid Arthritis. Completed, enrolled 621 participants across 1 site.
Detailed Summary
This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group, active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared with RoActemra in subjects with RA that is inadequately controlled by MTX. The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartDec 2018
First PostedFeb 2019
Primary CompletionJan 2021
TodayJul 2026
First PostedFeb 5, 2019
Enrollment StartDec 19, 2018
Primary CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.4 years ago
Interventions
BAT1806drug
8 mg/kg
Actemra(EU-licensed)drug
8 mg/kg