At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 101 enrolled
Drug / intervention
VIBEX MTXdevice
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.
Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.
In Brief
A Phase 2 clinical trial evaluating VIBEX MTX for Rheumatoid Arthritis (RA). Completed, enrolled 101 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis (RA)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedJun 2012
Primary CompletionJul 2012
TodayJul 2026
First PostedJun 14, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.0 years ago
Interventions
VIBEX MTXdevice
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device