Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration
Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis
1 other identifier
interventional
38
1 country
1
Brief Summary
Pharmacokinetics (PK) study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Jan 2011
Shorter than P25 for phase_1 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedResults Posted
Study results publicly available
February 25, 2014
CompletedFebruary 25, 2014
January 1, 2014
4 months
November 27, 2012
January 25, 2013
January 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
24 Hour period
Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX
Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC\[0-24\]/Dose) for each treatment
24 Hour period
Bioequivalence Based Upon Dose-Normalized Cmax for MTX
Dose-normalized maximum observed concentration for each treatment
24 Hour period
Study Arms (4)
10mg Methotrexate (MTX) Group
EXPERIMENTALTreatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
15mg Methotrexate (MTX) Group
EXPERIMENTALTreatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
20mg Methotrexate (MTX) Group
EXPERIMENTALTreatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
25mg Methotrexate (MTX) Group
EXPERIMENTALTreatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection
Interventions
Vibex MTX Device
Eligibility Criteria
You may qualify if:
- Male or female \>18 years of age with diagnosed Rheumatoid Arthritis(RA).
You may not qualify if:
- Chronic or acute renal disease
- Any other clinically significant disease or disorder which, in the opinion of the investigator, might put the subject at risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Jaffe, MD; Vice President Clinical Development
- Organization
- Antares Pharma
Study Officials
- PRINCIPAL INVESTIGATOR
Alan J Kivitz, MD;CPI
Altoona Center for Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
November 30, 2012
Study Start
January 1, 2011
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
February 25, 2014
Results First Posted
February 25, 2014
Record last verified: 2014-01