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OpenTrials
Completed

NCT Number: NCT00646386

Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

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 2

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 eow Week 0 - Week 24

Other names: ABT-D2E7, Humira

placebo for adalimumab

Drug

40 mg eow Week 0 - Week 24

Other names: placebo

Primary outcomes

  1. ACR20

    Time frame: Week 12

  2. Adverse Events

    Time frame: Throughout study participation

  3. Sharp Score

    Time frame: Week 24

Secondary outcomes

  1. ACR20, 50, 70

    Time frame: Weeks 12, 24

  2. Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI

    Time frame: Weeks 12 and 24

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 Moderately to Severely Active Psoriatic Arthritis

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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