At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 584 enrolled
Drug / intervention
Remicade (infliximab) +1 moredrug
Likely dose
Not stated in 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 Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
In Brief
A Phase 3 clinical trial evaluating Remicade (infliximab) and SB2 (proposed biosimilar to infliximab) for Rheumatoid Arthritis. Completed, enrolled 584 participants across 2 sites in 2 countries.
Detailed Summary
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Lithuania
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedSep 2013
Primary CompletionSep 2014
Study CompletionSep 2015
TodayJul 2026
First PostedSep 5, 2013
Enrollment StartAug 1, 2013
Primary CompletionSep 1, 2014
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.8 years ago
Interventions
Remicade (infliximab)drug
SB2 (proposed biosimilar to infliximab)drug