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VIBEX MTX · 1 trial · 1 indication
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following: 1. SC self-injection was administered by the patient 2. SC self-injection was intentional 3. self-injection was administered in an appropriate location on the abdomen 4. patient removed cap marked "1" 5. patient removed cap marked "2" 6. patient held device at injection site for 3 seconds 7. patient confirmed that the window was obstructed
| Arm | Type | Description |
|---|---|---|
| VIBEX MTX | ACTIVE_COMPARATOR | VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status |
| Name | Type | Description |
|---|---|---|
| VIBEX MTX | DEVICE | Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device |
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
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VIBEX MTX is used for the treatment of Rheumatoid Arthritis (RA). It is an investigational drug-device combination product being developed by Halozyme Therapeutics, Inc. (HALO) for the subcutaneous administration of methotrexate via an auto-injector device.
VIBEX MTX is being developed by Halozyme Therapeutics, Inc., which trades under the ticker symbol HALO. The company is conducting clinical development of this product for the treatment of Rheumatoid Arthritis (RA).
VIBEX MTX is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.
VIBEX MTX has one completed clinical trial, identified as NCT01618955, titled "Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device." This Phase 2 study enrolled 101 participants with Rheumatoid Arthritis (RA) in the United States.
VIBEX MTX is a product that delivers methotrexate subcutaneously via an auto-injector device. It is being developed for Rheumatoid Arthritis (RA) and is distinct from oral methotrexate formulations. The product is currently in Phase 2 clinical development.