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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: September 13, 2005
Last updated: August 28, 2007
Last verified: August 2007

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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00195689

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

No publications provided by Abbott

Additional publications automatically indexed to this study by Identifier (NCT Number): 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, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents processed this record on April 15, 2014