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Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Primary Purpose

Psoriasis, Arthritis, Psoriatic

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Etanercept

Methotrexate

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.

Secondary Outcome Measures

Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75

and 90. Time to clear or almost clear on PGA.

Full Information

NCT ID

NCT00161655

First Posted

September 8, 2005

Last Updated

September 25, 2009

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00161655

Brief Title

Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis, Arthritis, Psoriatic

Keywords

Psoriasis, Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Etanercept

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Primary Outcome Measure Information:

Title

Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.

Secondary Outcome Measure Information:

Title

Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75

Title

and 90. Time to clear or almost clear on PGA.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

Facility Information:

City

Fredriksberg Alle

State/Province

Copenhagen

Country

Denmark

City

Gentofte Amtsygehus

State/Province

Hellerup

Country

Denmark

City

Helsinki

Country

Finland

City

Tampere

Country

Finland

City

Rikshospitalet

State/Province

Olso

Country

Norway

City

Hudlegekontoret Akutten

State/Province

Tromso

Country

Norway

City

Lakarhuset Fasta Centrum

State/Province

Farsta

Country

Sweden

City

Lakarhuset

State/Province

Vallingby

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

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