Healthy Controls, Psoriasis, Psoriatic Arthritis
Conditions
Keywords
Psoriatic arthritis, Psoriasis, DMARD, Pain, Comorbidities, Ultrasound, Immunology, Patient-reported outcomes
Brief summary
The objective of the study is to investigate pain mechanisms, comorbidity status, biomarkers, patient reported outcome measures, ultrasonographic (US) inflammatory activity and association between these features in patients with psoriatic arthritis (PsA) intensifying anti-rheumatic treatment. Furthermore, to assess the predictive value of baseline pain profile, comorbidity status, and US joint/entheses activity on treatment outcome after 4 months. Finally, we aimed to compare baseline characteristics with I) patients with skin psoriasis without arthritis and II) healthy controls.
Detailed description
Patients with psoriatic arthritis, who initiate or switch anti-rheumatic treatment (conventional disease modifying drugs or biologic drugs) in routine care due to an active disease state, will be enrolled in the observational study. The overall aim is to investigate pain mechanisms, comorbidities and US psoriatic changes and elucidate if these factors - independently or by interaction - influence treatment response after 4 months. Patients will have a baseline visit, a follow up visit after 4 months and yearly thereafter. Examinations will be performed at all time points (except stated otherwise) and include: 1. Assessment of pain mechanisms by clinical evaluation (swollen/tender joint ratio, tender points) and pain questionnaires (widespread pain index, PainDETECT). 2. Ultrasonography of joints and entheses by two trained assessors 3. Clinical examination of all psoriatic manifestations 4. Interview and questionnaires regarding lifestyle, comorbidity status, function, quality of life and the impact of psoriatic manifestations. 5. Blood samples for standard rheumatic monitoring and biobank 6. X-ray of hands and feet (only at baseline) 7. AMPS test (assessment of motor and process skills) will be performed and interpreted by an certified ergo therapist (only at baseline visit and at 34-months follow-up and oly for the first included 20 PsA patients) Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of US, comorbidities, and pain mechanisms will be analysed. Subsequently, the analyses will be repeated for certain subgroups of patients (e.g., conventional drug therapy vs. biologic drug intervention) in an exploratory manner. We will compare baseline data including pain, fatigue, work, life style and comorbidity status of PsA patients before initiating new treatment with patients with skin psoriasis without arthritis and healthy controls
Interventions
OTHERClinical examination, blood sampling, ultrasonic assessment, and questionnaires
Visits include clinical examination, questionnaires (pain, comorbidity, lifestyle, work status) and ultrasonography of joints and entheses, blood samples, and only at baseline x-ray of hands and feet.
Sponsors
Frederiksberg University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with PsA according to the CASPAR (The Classification of Psoriatic Arthritis) criteria * Peripheral joint involvement. * Minimum 18 years of age. * Initiating or switching anti-rheumatic treatment due to active PsA. * Signing a written informed consent.
Exclusion criteria
* Pregnancy * Peripheral neuropathy * Demyelinising disease * Recent stroke * Other rheumatic inflammatory diseases. * Oral, intra-articular or intra-muscular glucocorticoids within 3 weeks prior to baseline * Treatment with centrally acting analgesics (opioids, anti-depressants, anticonvulsants) within 1 week prior to baseline * Treatment with mild analgesics (non-steroidal anti-inflammatory drugs, acetylsalicylic acid, acetaminophen) within 24 hours prior to baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American college of rheumatology 20%, | 4 months from baseline | Composite measures of improvement in disease state (20% improvement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Index in Psoriatic Arthritis (DAPSA) | 4 months from baseline | A composite measure of disease activity |
| Minimal Disease Activity (MDA) | 4 months from baseline | A composite measure of disease activity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in swollen joint count (SJC) | 4 months from baseline | — |
| Change in tender joint count (TJC) | 4 months from baseline | — |
| Change in Spondyloarthritis Research Consortium of Canada enthesitis score (SPARCC) | 4 months from baseline | — |
| Change in The Psoriatic Arthritis Impact of Disease-score (PsAID) | 4 months from baseline | — |
| Change in Dermatology Life Quality Index (DLQI) | 4 months from baseline | — |
| Change in Assessment of Motor and Process Skills (AMPS test) | 4 months from baseline | — |
| Transition Questionnaire score (Trans-Q) | 4 months from baseline | Patient's judgement of overall improvement during treatment |
| Change in PainDETECTquestionnaire score (PDQ) | 4 months from baseline | — |
| Change in Health Assessment Questionnaire disability index (HAQ) | 4 months from baseline | — |
| Change in Bath Ankylosing Spondylitis Functional Index (BASFI) | 4 months from baseline | — |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of pain | 4 months from baseline | — |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact | 4 months from baseline | — |
| Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical health | 4 months from baseline | — |
| Change in psoriasis area severity index (PASI) | 4 months from baseline | — |
| Change in ultrasonography joint scores (grey scale and doppler) | 4 months from baseline | — |
| Change in ultrasonography entheses scores (grey scale and doppler) | 4 months from baseline | — |
| Change in total cholesterol (mmol/L) | 4 months from baseline | — |
| Change in body weight (kg) | 4 months from baseline | — |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue | 4 months from baseline | — |
| Change in c-reactive protein (mg/L) | 4 months from baseline | — |
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 4 months from baseline | — |
Countries
Denmark
Contacts
Primary ContactZara R Stisen, MD
Backup ContactMarie Skougaard, MD
Outcome results
None listed