Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics (PK) study

Detailed Description
-----------------
To compare the pharmacokinetic (PK) profiles of methotrexate (MTX) following a subcutaneous (SC) injection of MTX using the Vibex device to that obtained after an SC injection of MTX without using the device and to that obtained after an intramuscular (IM) injection of MTX in adult subjects with rheumatoid arthritis (RA).

Official Title
-----------------
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

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Methotrexate (MTX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female >18 years of age with diagnosed Rheumatoid Arthritis(RA). Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10mg Methotrexate (MTX) Group<br>Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection | Drug: Methotrexate (MTX)<br>* Vibex MTX Device<br>* Other names: Device with MTX;|
| Experimental: 15mg Methotrexate (MTX) Group<br>Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection | Drug: Methotrexate (MTX)<br>* Vibex MTX Device<br>* Other names: Device with MTX;|
| Experimental: 20mg Methotrexate (MTX) Group<br>Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection | Drug: Methotrexate (MTX)<br>* Vibex MTX Device<br>* Other names: Device with MTX;|
| Experimental: 25mg Methotrexate (MTX) Group<br>Treatment Arm A - SC injection with Vibex device, Treatment Arm B - SC injection without device and Treatment Arm C - IM injection | Drug: Methotrexate (MTX)<br>* Vibex MTX Device<br>* Other names: Device with MTX;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methotrexate injection, subcutaneous, autoinjector