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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00646386
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 the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

Condition Intervention Phase
Arthritis Psoriatic Drug: adalimumab Drug: placebo for adalimumab Phase 2

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 Moderately to Severely Active Psoriatic Arthritis

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 study participation ]
  • Sharp Score [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • ACR20, 50, 70 [ Time Frame: Weeks 12, 24 ]
  • Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI [ Time Frame: Weeks 12 and 24 ]

Enrollment: 315
Study Start Date: March 2003
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 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
Antibodies
Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents