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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.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00427362
First received: January 26, 2007
Last updated: April 30, 2008
Last verified: April 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

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

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)
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427362

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

No publications provided by Abbott

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

ClinicalTrials.gov Identifier: NCT00427362     History of Changes
Other Study ID Numbers: W05-399, ACCLAIM
Study First Received: January 26, 2007
Last Updated: April 30, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
 Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013