At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
MTXdrug
Likely dose
MTX 10 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.
Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
In Brief
A Phase 2 clinical trial evaluating MTX for Rheumatoid Arthritis (RA). Completed, enrolled 49 participants across 1 site.
Detailed Summary
Relative Bioavailability Comparison study
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 CompletionAug 2012
TodayJul 2026
First PostedJun 14, 2012
Enrollment StartMay 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.0 years ago
Interventions
MTXdrug
* Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group) * Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) * Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)