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
  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:


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
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 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
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Immunologic Factors

ClinicalTrials.gov processed this record on October 20, 2014