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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)

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

Tracking Information
First Submitted Date  ICMJE January 26, 2007
First Posted Date  ICMJE January 29, 2007
Last Update Posted Date May 2, 2008
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2007)
ACR20 response [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2007)
ACR20 response at Week 12
Change History Complete list of historical versions of study NCT00427362 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2007)
  • ACR50
  • ACR70
  • PsARC
  • DAS28
  • PASI50/75
  • HAQ-DI
  • PsAQoL
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE Drug: Adalimumab
Study Arms  ICMJE Not Provided
Publications * Gladman DD; ACCLAIM Study Investigators, Sampalis JS, Illouz O, Guérette B. Responses to adalimumab in patients with active psoriatic arthritis who have not adequately responded to prior therapy: effectiveness and safety results from an open-label study. J Rheumatol. 2010 Sep;37(9):1898-906. doi: 10.3899/jrheum.100069. Epub 2010 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2007)
127
Original Enrollment  ICMJE
 (submitted: January 26, 2007)
260
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00427362
Other Study ID Numbers  ICMJE W05-399
ACCLAIM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Benoit Guerette, PhD Abbott
PRS Account Abbott
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP