Back to resultsA 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)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
ACR20 response
Secondary Outcome Measures
ACR50
ACR70
PsARC
DAS28
PASI50/75
HAQ-DI
PsAQoL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00427362
Brief 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)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Primary Outcome Measure Information:
Title
ACR20 response
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
ACR50
Time Frame
Week 12
Title
ACR70
Time Frame
Week 12
Title
PsARC
Time Frame
Week 12
Title
DAS28
Time Frame
Week 12
Title
PASI50/75
Time Frame
Week 12
Title
HAQ-DI
Time Frame
Week 12
Title
PsAQoL
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Guerette, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20595284
Citation
Gladman DD; ACCLAIM Study Investigators; Sampalis JS, Illouz O, Guerette 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.
Results Reference
derived
Learn more about this trial
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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