Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

NCT00245960

Last updated date
Study Location
Buenos Aires, , 1234, Argentina
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE Drug: etanercept
Group A: Period 1: 50mg BIW. Period 2: 50 mg QW. Group B: Period 1 and 2: 50mg QW.
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: etanercept
  • Active Comparator: B
    Intervention: Drug: etanercept
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2009)
752
Original Enrollment  ICMJE
 (submitted: October 27, 2005)
800
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Saudi Arabia,   Serbia,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom
Removed Location Countries Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00245960
Other Study ID Numbers  ICMJE 0881A5-401
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Trial ManagerFor Argentina, [email protected] or [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Denmark, Finland, Sweden, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Greece, [email protected]
Principal Investigator:Trial MangerFor Hungary, [email protected]
Principal Investigator:Trial ManagerFor Australia, Korea, Taiwan, [email protected]
Principal Investigator:Trial ManagerFor Mexico, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial managerFor Switzerland, [email protected]
Principal Investigator:Trial ManagerFor Turkey, [email protected]
Principal Investigator:Trial ManagerFor UK, [email protected]Â
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor Portugal,Saudi Arabia, [email protected]
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Spain, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP