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)
2 other identifiers
interventional
127
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedMay 2, 2008
April 1, 2008
1 year
January 26, 2007
April 30, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
ACR20 response
Week 12
Secondary Outcomes (7)
ACR50
Week 12
ACR70
Week 12
PsARC
Week 12
DAS28
Week 12
PASI50/75
Week 12
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Related Publications (1)
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.
PMID: 20595284DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Benoit Guerette, PhD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 26, 2007
First Posted
January 29, 2007
Study Start
May 1, 2006
Primary Completion
May 1, 2007
Last Updated
May 2, 2008
Record last verified: 2008-04