You are here

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Buenos Aires, , 1234 Argentina
Contact
1-800-718-1021
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

NCT00245960
Pfizer
Completed
Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Psoriatic Arthritis
NCT03486457
All Genders
18+
Years
Multiple Sites
Rheumatoid Arthritis, Psoriatic Arthritis
NCT02984020
All Genders
19+
Years
Multiple Sites
Crohn Desease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
NCT02925338
All Genders
6+
Years
Multiple Sites
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 SummaryTo 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 DescriptionNot 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 DateMay 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 CountriesFormer Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00245960
Other Study ID Numbers  ICMJE 0881A5-401
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMarch 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now