Psoriatic Arthritis
Conditions
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
Interventions
DRUGAdalimumab
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| ACR70 | Week 12 |
| PsARC | Week 12 |
| DAS28 | Week 12 |
| ACR50 | Week 12 |
| HAQ-DI | Week 12 |
| PsAQoL | Week 12 |
| PASI50/75 | Week 12 |
Outcome results
None listed