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MTX

Phase 2

Rheumatoid Arthritis (RA) | Small molecule | Immunology |Halozyme Therapeutics, Inc.|Last Updated: May 19, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

MTX · 1 trial · 1 indication

Phase 2 1
NCT01618968Comparison of Methotrexate (MTX) and the VIBEX™ MTX DeviceRheumatoid Arthritis (RA)
COMPLETED49 Analytics
PHASE2COMPLETED
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
Rheumatoid Arthritis (RA)Unlock trial analytics

Study Endpoints

Primary Endpoints

Dose-Normalized AUC[0-Inf] for MTX
24 Hour period

Dose-normalized area under the curve from time zero to infinity (AUC\[0-inf\]/Dose) for each treatment

Dose-Normalized AUC[0-24] for MTX
24 Hour period

Dose-normalized area under the curve from time zero to 24 hours (AUC\[0-24\]/Dose) for each treatment

Dose-Normalized Cmax for MTX
24 Hour period

Dose-normalized maximum observed concentration (Cmax) for each treatment

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
10 mg Methotrexate (MTX)EXPERIMENTALMTX 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 MTXEXPERIMENTALMTX 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 MTXEXPERIMENTALMTX 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 MTXEXPERIMENTALMTX 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.

Interventions

NameTypeDescription
MTXDRUG* 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)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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

Countries:United States
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Frequently asked questions about MTX

What is MTX used for in Rheumatoid Arthritis?

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.

Who makes MTX?

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.

What phase is MTX in?

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.

What clinical trials is MTX in?

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.

Is MTX the same as Methotrexate?

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.