Study Evaluating Etanercept and Methotrexate in Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT00161655
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Last Update Posted: September 28, 2009
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: September 8, 2005
• First Posted Date: September 12, 2005
• Last Update Posted Date: September 28, 2009
• Study Start Date: April 2005
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 8, 2005): Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 8, 2005)

• Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
• and 90. Time to clear or almost clear on PGA.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Psoriasis
• Arthritis, Psoriatic

Intervention

• Drug: Etanercept
• Drug: Methotrexate

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 8, 2005): 60
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2006
• Actual Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, Finland, Norway, Sweden

Administrative Information

• NCT Number: NCT00161655
• Other Study ID Numbers: 0881A-101696
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: September 2009