Psoriatic Arthritis
Conditions
Keywords
Assessing Effectiveness in Psoriatic Arthritis
Brief summary
The current study will assess the real - life effectiveness of adalimumab in the management of articular and dermatological manifestations of moderate to severe Psoriatic Arthritis (PsA).
Interventions
None listed
Sponsors
Cato Research
JSS Medical Research Inc.
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adult \>= 18 years old * Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel * Active Psoriatic Arthritis (PsA) with three (3) or more tender and swollen joints as well as active psoriatic skin lesions or confirmed history of psoriasis * Inadequate response or non-tolerant to current disease-modifying antirheumatic drugs (DMARD) based treatment for PsA
Exclusion criteria
* Currently participating in another prospective study including controlled clinical trials and observational studies * Patient cannot or will not sign informed consent * Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated * Previous treatment with anti-tumor necrosis factor (anti-TNF) or other biologic agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Disease Activity Score - 28 (DAS-28) | Every 3 months up to 6 months, then every 6 months up to 24 months | The DAS - 28 is calculated using the number of swollen (SJC) and tender (TJC) joints out of 28, the erythrocyte sedimentation rate (ESR) and the patient's global assessment of disease activity using a 100 mm visual analogue scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Morning Stiffness (min) | Every 3 months up to 6 months, then every 6 months up to 24 months | This is ascertained by the treating physician during the patient assessment and is measured in minutes |
| Dermatology Life Quality Index (DLQI) | Baseline, month 6, month12, month 24 | This is a self-administered questionnaire comprised of 10 items assessing a patient's skin and problems associated with skin disease. The 10 questions in the DLQI converge into six domains that measure symptoms and feelings, daily activities, leisure, work and / or school, personal relationships and satisfaction with treatment. |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | Every 3 months up to 6 months, then every 6 months up to 24 months | Self-administered questionnaire measuring the patient's functional ability during the last week. |
| Patient Global Assessment of Disease Activity (VAS and 5 Point Scale) | Every 3 months up to 6 months, then every 6 months up to 24 months | A 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity and a five point Likert Scale (0 - 4) that is completed by the patient at the physician's office |
| Physician Global Assessment of Disease Activity (VAS and 5 Point Scale) | Every 3 months up to 6 months, then every 6 months up to 24 months | This is a 100 mm VAS with 0 indicating lowest disease and 100 highest disease activity a five point Likert Scale (0 - 4) that is completed by the physician during the patient examination |
Countries
Canada
Outcome results
None listed