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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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00646178
First received: March 26, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
March 26, 2008
March 26, 2008
June 2003
March 2004   (Final data collection date for primary outcome measure)
  • ACR20 [ Time Frame: Week 12 ]
  • Adverse Events [ Time Frame: Throughout the Study ]
Same as current
No Changes Posted
  • ACR50/70 [ Time Frame: Week 12 ]
  • Modified Psoriatic Arthritis Response Criteria [ Time Frame: Week 12 ]
  • Multiple QOL Assessments [ Time Frame: Week 12 ]
  • Physicians Global Assessment for Psoriasis [ Time Frame: Week 12 ]
Same as current
Not Provided
Not Provided
 
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 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
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
  • Arthritis
  • Psoriatic
  • Drug: adalimumab
    40 mg adalimumab eow Week 0 - Week 12
    Other Names:
    • ABT-D2E7
    • Humira
  • Drug: placebo for adalimumab
    placebo eow Week 0 - Week 12
    Other Name: placebo
  • Active Comparator: A
    Intervention: Drug: adalimumab
  • Placebo Comparator: B
    Intervention: Drug: placebo for adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
Not Provided
March 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00646178
M02-570
Not Provided
Not Provided
Not Provided
Not Provided
Beverly Paperiello / Director, Clinical Research Development, Abbott
Abbott
Not Provided
Not Provided
Abbott
March 2008

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