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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)

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: NCT00427362
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : May 2, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
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 or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : May 2006
Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

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




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

Secondary Outcome Measures :
  1. ACR50 [ Time Frame: Week 12 ]
  2. ACR70 [ Time Frame: Week 12 ]
  3. PsARC [ Time Frame: Week 12 ]
  4. DAS28 [ Time Frame: Week 12 ]
  5. PASI50/75 [ Time Frame: Week 12 ]
  6. HAQ-DI [ Time Frame: Week 12 ]
  7. PsAQoL [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00427362


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

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
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: May 2, 2008
Last Verified: April 2008

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
Anti-Inflammatory Agents
Antirheumatic Agents