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OpenTrials
Completed

NCT Number: NCT00245960

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital A Posadas, Palomar, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

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

Treatment and study plan

etanercept

Drug

Placebo

Drug

Primary outcomes

  1. Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis

    Time frame: 12 weeks

    The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.

Secondary outcomes

  1. Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)

    Time frame: 12 and 24 weeks

    The PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 28, 2005
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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