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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:
ClinicalTrials.gov Identifier:
NCT00646178
First Posted: March 28, 2008
Last Update Posted: March 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
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

Condition Intervention Phase
Arthritis Psoriatic Drug: adalimumab Drug: placebo for adalimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • ACR20 [ Time Frame: Week 12 ]
  • Adverse Events [ Time Frame: Throughout the Study ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 102
Study Start Date: June 2003
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: adalimumab
40 mg adalimumab eow Week 0 - Week 12
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: B Drug: placebo for adalimumab
placebo eow Week 0 - Week 12
Other Name: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Beverly Paperiello / Director, Clinical Research Development, Abbott
ClinicalTrials.gov Identifier: NCT00646178     History of Changes
Other Study ID Numbers: M02-570
First Submitted: March 26, 2008
First Posted: March 28, 2008
Last Update Posted: March 28, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Anti-Inflammatory Agents