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Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00245960
First received: October 26, 2005
Last updated: March 31, 2009
Last verified: March 2009
  Purpose

To assess the efficacy of two different treatment regimens of etanercept in psoriasis subjects with psoriatic arthritis with respect to both the skin and joint manifestations.


Condition Intervention Phase
Psoriatic Arthritis
Drug: etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Two-Period Study to Evaluate the Safety and Efficacy of Etanercept on Skin and Joint Disease in Psoriasis Subjects With Psoriatic Arthritis.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 752
Study Start Date: December 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: etanercept
Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.
Active Comparator: B Drug: etanercept
Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.

  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older at time of consent
  • Active Psoriatic Arthritis
  • Clinically stable, plaque psoriasis involving more than 10% of the body surface area

Exclusion Criteria:

  • Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
  • Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
  • Prior exposure to any TNF-inhibitor, including etanercept
  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: NCT00245960

  Show 117 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Trial Manager For Argentina, scheima@wyeth.com or rendop@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Denmark, Finland, Sweden, MedInfoNord@wyeth.com
Principal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Greece, decresg@wyeth.com
Principal Investigator: Trial Manger For Hungary, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Australia, Korea, Taiwan, medinfo@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezlj@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial manager For Switzerland, med@wyeth.com
Principal Investigator: Trial Manager For Turkey, Erisc@wyeth.com
Principal Investigator: Trial Manager For UK, ukmedinfo@wyeth.comÂ
Principal Investigator: Trial Manager For Austria, WPVIMED@wyeth.com
Principal Investigator: Trial Manager For Portugal,Saudi Arabia, clintrialparticipation@wyeth.com
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00245960     History of Changes
Other Study ID Numbers: 0881A5-401
Study First Received: October 26, 2005
Results First Received: March 31, 2009
Last Updated: March 31, 2009
Health Authority: European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Psoriatic Arthritis
Skin Disease
Joint Disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Bone Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014