At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 544 enrolled
Drug / intervention
Humira (adalimumab) +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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Humira (adalimumab) and SB5 (proposed biosimilar to adalimumab) for Rheumatoid Arthritis. Completed, enrolled 544 participants across 2 sites in 2 countries.
Detailed Summary
This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesLithuania, Poland
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedJun 2014
Primary CompletionApr 2015
Study CompletionOct 2015
TodayJul 2026
First PostedJun 18, 2014
Enrollment StartMay 1, 2014
Primary CompletionApr 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.0 years ago
Interventions
Humira (adalimumab)drug
SB5 (proposed biosimilar to adalimumab)drug