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OpenTrials
Completed

NCT Number: NCT00646178

Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy

Completed

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases Psoriatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe PsA
  • Inadequate response to DMARD therapy
  • Corticosteroid stable dose <=10 mg QD
  • DMARDs must have been taken for 3 months and stable dose for 4 weeks
  • MTX maximum dose = <=30 mg/week
  • Active chronic plaque PS or documented history of chronic plaque PS

Exclusion criteria

  • No other active skin disease

Treatment and study plan

Adalimumab

Drug

40 mg adalimumab eow Week 0 - Week 12

Other names: ABT-D2E7, Humira

placebo for adalimumab

Drug

placebo eow Week 0 - Week 12

Other names: placebo

Primary outcomes

  1. ACR20

    Time frame: Week 12

  2. Adverse Events

    Time frame: Throughout the Study

Secondary outcomes

  1. ACR50/70

    Time frame: Week 12

  2. Modified Psoriatic Arthritis Response Criteria

    Time frame: Week 12

  3. Multiple QOL Assessments

    Time frame: Week 12

  4. Physicians Global Assessment for Psoriasis

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

Important dates

Study start
2003
Primary completion
2004
First posted
Mar 28, 2008
Registry last updated
Mar 28, 2008

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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