Phase 2
Completed N=49
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01618968 ↗
Enrolled (actual)
49
Serious AEs
4.1%
Results posted
May 2014
Primary outcomePrimary: Dose-Normalized AUC[0-Inf] for MTX — 109.47; 140.84; 136.45 ng*hr/mL/mg
Summary
Relative Bioavailability Comparison study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-Normalized AUC[0-Inf] for MTX |
109.47; 140.84; 136.45 | — |
| PRIMARY Dose-Normalized AUC[0-24] for MTX |
107.64; 137.88; 133.78 | — |
| PRIMARY Dose-Normalized Cmax for MTX |
22.697; 21.935; 18.436 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients ≥18 years of age, diagnosed with Rheumatoid Arthritis
Exclusion Criteria
- Pregnant females
- Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
Data sourced from ClinicalTrials.gov (NCT01618968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.