At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 33 enrolled
Drug / intervention
M923 +1 morebiological
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.
An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
In Brief
A Phase 3 clinical trial evaluating M923 and Autoinjector for Rheumatoid Arthritis. Completed, enrolled 33 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate the usability of an auto-injector (AI) for the delivery of M923 in patients with rheumatoid arthritis (RA)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionFeb 2017
TodayJul 2026
First PostedMar 29, 2016
Enrollment StartApr 1, 2016
Primary CompletionFeb 21, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.3 years ago
Interventions
M923biological
Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Autoinjectordevice
Subcutaneous administration