Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis (PIPA)

Frederiksberg University Hospital

Status: Enrolling

Conditions: Psoriasis; Healthy Controls; Psoriatic Arthritis

Treatments: Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT02572700

H-15009080

Details and patient eligibility

About

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.

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 3 patient groups

Patients with psoriatic arthritis

Description:

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.

Treatment:

Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires

Patients with skin psoriasis without arthrits

Description:

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.

Treatment:

Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires

Healthy controls

Description:

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.

Treatment:

Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires