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Completed

NCT Number: NCT00161655

Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

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.

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Key information

Conditions

Psoriasis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fredriksberg Alle, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

methotrexate

Drug

Primary outcomes

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

Secondary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Sep 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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