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The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adding Methotrexate to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

NCT01001208•Amgen

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is capable of understanding and giving written, voluntary informed consent before study screening
•Male or female ≥18 years of age at time of screening
•Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity)
•Has involved body surface area (BSA) ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline
•Is a candidate for systemic therapy or phototherapy in the opinion of the investigator
•Has a negative test for hepatitis B surface antigen and hepatitis C antibody
•Has a negative purified protein derivative test within 30 days prior to the first IP dose. Tuberculin skin tests should be considered positive when they have greater than or equal to 5 mm of induration at 48-72 hours after test is placed. Patients with a positive tuberculin skin test (if less than or equal to 14 mm of induration) are allowed if they have a history of Bacillus Calmette-Guerin vaccination with a negative Quantiferon test in the past year, no symptoms per tuberculosis worksheet, and a negative chest X ray.
•Has a negative serum pregnancy test within 28 days before initiating Investigational Product (IP) and negative urine pregnancy test at baseline for females (except those at least 3 years post menopausal or surgically sterile)
•Females are willing to use highly effective form of birth control (decided upon with the investigator) during the study and for 3 months after the end of treatment (except women at least 3 years post menopausal or surgically sterile)
•Males are willing to use highly effective form of birth control (decided upon with the investigator) during the study and for 5 months after the end of treatment (except for men who are surgically sterile or whose female partners are at least 3 years post menopausal, surgically sterile, or are using a highly effective form of birth control)
+2 more criteria

Exclusion Criteria

•Skin-disease related
•Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
•Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of IP on psoriasis.
•Medical conditions
•Has significant concurrent medical conditions, including:
•Type 1 diabetes
•Poorly controlled type 2 diabetes (hemoglobin A1c \> 8.5)
•Symptomatic heart failure (New York Heart Association \[NYHA\] class II, III, or IV)
•Myocardial infarction within the last year
•Current or history of unstable angina pectoris within the last year
+51 more criteria

Key Dates

Start Date

November 1, 2009

Primary Completion Date

December 1, 2010

Completion Date

February 1, 2011

Last Updated

August 12, 2013

Enrollment

478

ACTUAL participants

Conditions

Psoriasis

Interventions

Methotrexate

DRUG

Etanercept

DRUG

Placebo

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

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RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments