NCT Number: NCT00427362
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)
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
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
ACR20 response
Time frame: Week 12
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Abbott
Industry
Registry information
Important dates
- Study start
- 2006
- Primary completion
- 2007
- First posted
- Jan 29, 2007
- Registry last updated
- May 2, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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