At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
Adalimumab, current formulation +1 morebiological
Likely dose
Adalimumab, current formulation 40 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.
Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis
In Brief
A Phase 2 clinical trial evaluating Adalimumab, current formulation and Adalimumab, new formulation for Rheumatoid Arthritis. Completed, enrolled 100 participants across 21 sites in 7 countries.
Detailed Summary
A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for pharmacodynamics, pharmacokinetics, and safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Czechia, Germany, Puerto Rico, Romania, Slovakia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedOct 2012
Primary CompletionMay 2013
TodayJul 2026
First PostedOct 23, 2012
Enrollment StartJun 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.7 years ago
Interventions
Adalimumab, current formulationbiological
Current formulation adalimumab 40 mg every other week
Adalimumab, new formulationbiological
New formulation adalimumab 40 mg every other week