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Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: September 8, 2005
Last updated: September 25, 2009
Last verified: September 2009
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.

Condition Intervention Phase
Psoriasis Arthritis, Psoriatic Drug: Etanercept Drug: Methotrexate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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.

Estimated Enrollment: 60
Study Start Date: April 2005
Study Completion Date: December 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00161655

Fredriksberg Alle, Copenhagen, Denmark
Gentofte Amtsygehus, Hellerup, Denmark
Helsinki, Finland
Tampere, Finland
Rikshospitalet, Olso, Norway
Hudlegekontoret Akutten, Tromso, Norway
Lakarhuset Fasta Centrum, Farsta, Sweden
Lakarhuset, Vallingby, Sweden
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00161655     History of Changes
Other Study ID Numbers: 0881A-101696
Study First Received: September 8, 2005
Last Updated: September 25, 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spinal Diseases
Bone Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal processed this record on August 18, 2017