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Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00195689
First received: September 13, 2005
Last updated: August 28, 2007
Last verified: August 2007
History of Changes
  Purpose
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis

Condition Intervention Phase
Psoriatic Arthritis
 Biological: Human anti-TNF monoclonal antibody/adalimumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety parameters
  • ACR 20/50/70
  • PsARC
  • HAQ
  • SF-36
  • FACTIT Fatigue Scale
  • Disease progression measurements

Secondary Outcome Measures:
  • Patient reported outcomes
  • Clinical response indicators
Estimated Enrollment: 400
Study Start Date: August 2003
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject completed study M02-518 or M02-570

Exclusion Criteria:

  • Subject prematurely discontinued study M02-518 or M02-570

    • Female subject who is pregnant or breast-feeding or considering becoming pregnant
    • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195689

Locations
United States, Illinois
Global Medical Information-Abbott Laboratories
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00195689     History of Changes
Other Study ID Numbers: M02-537 
Study First Received: September 13, 2005
Last Updated: August 28, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016