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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

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ClinicalTrials.gov Identifier: NCT00646178
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 Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy

Condition or disease Intervention/treatment Phase
Arthritis Psoriatic Drug: adalimumab Drug: placebo for adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 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 Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy
Study Start Date : June 2003
Actual Primary Completion Date : March 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 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



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

Secondary Outcome Measures :
  1. ACR50/70 [ Time Frame: Week 12 ]
  2. Modified Psoriatic Arthritis Response Criteria [ Time Frame: Week 12 ]
  3. Multiple QOL Assessments [ Time Frame: Week 12 ]
  4. Physicians Global Assessment for Psoriasis [ Time Frame: Week 12 ]


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

Responsible Party: Beverly Paperiello / Director, Clinical Research Development, Abbott
ClinicalTrials.gov Identifier: NCT00646178     History of Changes
Other Study ID Numbers: M02-570
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
Adalimumab
Antirheumatic Agents
Anti-Inflammatory Agents