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MTX

Phase 3

Psoriasis | Small molecule | Dermatology |Abbott Laboratories|Last Updated: Jul 17, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment271

FDA Designations

No designations recorded

Clinical trial landscape

MTX · 1 trial · 1 indication

Phase 3 1
NCT00235820Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque PsoriasisPsoriasis
COMPLETED271 Analytics
PHASE3COMPLETED
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
Week 16
Safety parameters
Every Study Visit

Secondary Endpoints

Physician Global Assessment
Baseline - Week 16
PASI 50/90/100
Baseline - Week 16
DLQI
Baseline - Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
CPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
adalimumabDRUG40 mg every other week following an 80 mg dose
MTXDRUGMTX 7.5 to 25 mg once weekly
placebo adalimumab, placebo MTXDRUGplacebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)
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Eligibility Criteria

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

Inclusion Criteria: * Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis * Subject is a candidate for systemic therapy or pho...

Countries:United States
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Frequently asked questions about MTX

What is MTX used for in psoriasis?

MTX is a small molecule being studied for the treatment of moderate to severe chronic plaque psoriasis. It is being evaluated in a Phase 3 clinical trial as an active comparator against adalimumab and placebo. The drug is intended for use in adult patients with this dermatological condition.

What does MTX target?

MTX is a small molecule therapeutic. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being investigated for its efficacy and safety in treating moderate to severe chronic plaque psoriasis, a condition characterized by scaly skin patches.

Who makes MTX?

MTX is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker symbol ABT. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with moderate to severe chronic plaque psoriasis.

What phase is MTX in?

MTX is in Phase 3 clinical development. It has completed one Phase 3 trial with a total enrollment of 271 participants. The trial was a randomized, double-blind, placebo-controlled study conducted in the United States. MTX is still investigational and has not been approved by regulatory authorities.

What clinical trials is MTX in?

MTX has been studied in one completed Phase 3 clinical trial with the identifier NCT00235820. The trial, titled 'Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis,' enrolled 271 participants in the United States. The study was randomized, double-blind, and placebo-controlled.

Is MTX the same as methotrexate?

MTX is commonly used as an abbreviation for methotrexate, a medication used in the treatment of psoriasis and other conditions. In the context of the clinical trial NCT00235820, MTX refers to methotrexate, which was compared against adalimumab and placebo in patients with moderate to severe chronic plaque psoriasis.