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Trial record 1 of 1 for:    NCT00646386
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Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

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.
 
ClinicalTrials.gov Identifier: NCT00646386
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:
Abbott

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

Condition or disease Intervention/treatment Phase
Arthritis Psoriatic Drug: adalimumab Drug: placebo for adalimumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
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 Moderately to Severely Active Psoriatic Arthritis
Study Start Date : March 2003
Actual Primary Completion Date : April 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: adalimumab
40 mg eow Week 0 - Week 24
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: B Drug: placebo for adalimumab
40 mg eow Week 0 - Week 24
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. ACR20 [ Time Frame: Week 12 ]
  2. Adverse Events [ Time Frame: Throughout study participation ]
  3. Sharp Score [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Beverly Paperiello/Director, Clinical Development Operations, Abbott
ClinicalTrials.gov Identifier: NCT00646386    
Other Study ID Numbers: M02-518
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
 Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Antirheumatic Agents