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Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00161655
First received: September 8, 2005
Last updated: September 25, 2009
Last verified: September 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161655

Locations
Denmark
Fredriksberg Alle, Copenhagen, Denmark
Gentofte Amtsygehus, Hellerup, Denmark
Finland
Helsinki, Finland
Tampere, Finland
Norway
Rikshospitalet, Olso, Norway
Hudlegekontoret Akutten, Tromso, Norway
Sweden
Lakarhuset Fasta Centrum, Farsta, Sweden
Lakarhuset, Vallingby, Sweden
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161655     History of Changes
Other Study ID Numbers: 0881A-101696
Study First Received: September 8, 2005
Last Updated: September 25, 2009
Health Authority: Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Swedish National Council on Medical Ethics
Finland: Ethics Committee

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents, Nonsteroidal
 Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013