Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161655

Enrollment

Registered

2005-09-12

Start date

2005-04-30

Completion date

2006-12-31

Last updated

2009-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriatic, Psoriasis

Keywords

Psoriasis, Arthritis

Brief summary

The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.

Interventions

DRUGEtanercept

DRUGMethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Active plaque psoriasis involving \>10% body surface area and/or minimal screening PASI score 8. * Methotrexate \>7.5 mg/week for the last 3 months

Exclusion criteria

* Predominantly guttate, erythrodermic or pustular psoriasis * Other skin conditions than psoriasis

Design outcomes

Primary

Measure	Time frame
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.	—

Secondary

Measure	Time frame
Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75	—
and 90. Time to clear or almost clear on PGA.	—

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026