Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MTX · 1 trial · 1 indication
Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment
Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment
Dose-normalized maximum observed concentration (Cmax) for each treatment
| Arm | Type | Description |
|---|---|---|
| 10 mg Methotrexate (MTX) | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| 15 mg MTX | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| 20 mg MTX | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| 25 mg MTX | EXPERIMENTAL | MTX dose group was assigned based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status. The sequence of treatments A, B and C was randomly assigned. |
| Name | Type | Description |
|---|---|---|
| MTX | DRUG | * Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group) * Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) * Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX) |
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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MTX is a small molecule being developed by Halozyme Therapeutics for the treatment of Rheumatoid Arthritis (RA). It is currently in Phase 2 clinical development as an investigational therapy. The drug is being studied for its potential to manage this autoimmune condition, though it is not yet approved.
MTX is being developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HALO. The company is conducting clinical research on this drug for the treatment of Rheumatoid Arthritis.
MTX is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of Rheumatoid Arthritis, and its clinical program includes a completed Phase 2 trial.
MTX has one completed clinical trial registered as NCT01618968, titled "Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device." This Phase 2 study enrolled 49 participants with Rheumatoid Arthritis in the United States. The trial was controlled but not double-blinded.
Yes, MTX is an abbreviation for Methotrexate, a well-known medication used in the treatment of Rheumatoid Arthritis. In the clinical trial context, MTX refers to this drug, which is being studied by Halozyme Therapeutics for its efficacy and delivery method.