Phase 2
Completed N=101
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01618955 ↗
Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Apr 2014
Primary outcomePrimary: Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection — 100; 100; 100; 100 Percentage of Participants
Summary
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools |
95; 100; 97; 100; 100; 100 | — |
| SECONDARY Safety of Vibex MTX Device |
95; 88.3; 96.0; 90.0; 5; 11.7 | — |
| SECONDARY Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain) |
1.0; 7.6; 2.2; 2.4; 1.7; 2.0 | — |
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 (NCT01618955). 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.