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A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)

This study has been completed.
Information provided by:
Abbott Identifier:
First received: January 26, 2007
Last updated: April 30, 2008
Last verified: April 2008
To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who have had an unsatisfactory response or intolerance to prior or ongoing DMARDs

Condition Intervention Phase
Psoriatic Arthritis
Drug: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • ACR20 response [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • ACR50 [ Time Frame: Week 12 ]
  • ACR70 [ Time Frame: Week 12 ]
  • PsARC [ Time Frame: Week 12 ]
  • DAS28 [ Time Frame: Week 12 ]
  • PASI50/75 [ Time Frame: Week 12 ]
  • HAQ-DI [ Time Frame: Week 12 ]
  • PsAQoL [ Time Frame: Week 12 ]

Enrollment: 127
Study Start Date: May 2006
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Active psoriatic arthritis defined by >= 3 tender or painful joints and >= 3 swollen joints despite standard psoriatic arthritis therapy
  • Has had an unsatisfactory response or intolerance to at least two prior or ongoing DMARDs (one of which has to be methotrexate)

Exclusion Criteria:

  • Has a history of cancer or other than certain skin or cervical cancers
  • Has a history of, or current acute inflammatory joint disease of origin other than PsA, e.g., systemic lupus erythematosus etc.
  • Has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk
  • History of active tuberculosis, history of histoplasmosis or listeriosis
  • Latent TB or risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT00427362

Sponsors and Collaborators
Study Director: Benoit Guerette, PhD Abbott
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00427362     History of Changes
Other Study ID Numbers: W05-399
Study First Received: January 26, 2007
Last Updated: April 30, 2008

Additional relevant MeSH terms:
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017