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

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.
 
ClinicalTrials.gov Identifier: NCT00195689
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 29, 2007
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Psoriatic Arthritis Biological: Human anti-TNF monoclonal antibody/adalimumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety parameters
  2. ACR 20/50/70
  3. PsARC
  4. HAQ
  5. SF-36
  6. FACTIT Fatigue Scale
  7. Disease progression measurements

Secondary Outcome Measures :
  1. Patient reported outcomes
  2. Clinical response indicators

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195689


Locations
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United States, Illinois
Global Medical Information-Abbott Laboratories
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Beverly Paperiello Abbott
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00195689    
Other Study ID Numbers: M02-537
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: August 2007
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
 Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents