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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

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

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 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
U.S. FDA Resources

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



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 ]


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beverly Paperiello/Director, Clinical Development Operations, Abbott
ClinicalTrials.gov Identifier: NCT00646386     History of Changes
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:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies
Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents