Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis

Study Overview
=================
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: Assessment of pain mechanisms by clinical evaluation (swollen/tender joint ratio, tender points) and pain questionnaires (widespread pain index, PainDETECT). Ultrasonography of joints and entheses by two trained assessors Clinical examination of all psoriatic manifestations Interview and questionnaires regarding lifestyle, comorbidity status, function, quality of life and the impact of psoriatic manifestations. Blood samples for standard rheumatic monitoring and biobank X-ray of hands and feet (only at baseline) 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

Official Title
-----------------
Pain Mechanisms and Ultrasonographic Inflammatory Changes as Prognostic Factors in Patients With Psoriatic Arthritis: a Prospective, Exploratory Cohort Study

Conditions
-----------------
Psoriatic Arthritis, Psoriasis, Healthy Controls

Intervention / Treatment
-----------------
* Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with psoriatic arthritis<br>PsA patients initiating anti-rheumatic treatment in routine care will be included as one group in the observational study. Analyses will be carried out for the overall study population as well as for subgroups (e.g., stratified according to treatment intervention) in an exploratory manner. | Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires<br>* 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.<br>|
| Patients with skin psoriasis without arthrits<br>20 patients with skin psoriasis without arthrits will be included as one group at baseline only. Baseline characteristics including status of pain, fatigue, work, comorbidity and lifestyle factors will be recorded. | Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires<br>* 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.<br>|
| Healthy controls<br>20 healthy controls will be included as one group at baseline only. Baseline characteristics including status of pain, fatigue, work, comorbidity and lifestyle factors will be recorded. | Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American college of rheumatology 20%, | Composite measures of improvement in disease state (20% improvement) | 4 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Index in Psoriatic Arthritis (DAPSA) | A composite measure of disease activity | 4 months from baseline | 
| Minimal Disease Activity (MDA) | A composite measure of disease activity | 4 months from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriatic arthritis, Psoriasis, DMARD, Pain, Comorbidities, Ultrasound, Immunology, Patient-reported outcomes