Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis

Recruiting

• Conditions: Healthy Controls; Psoriatic Arthritis; Psoriasis
• Interventions: Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires

• Registration Number: NCT02572700
• Lead Sponsor: Frederiksberg University Hospital

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

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Clinical examination, blood sampling, ultrasonic assessment, and questionnaires	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.
Patients with psoriatic arthritis	Clinical examination, blood sampling, ultrasonic assessment, and questionnaires	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.
Patients with skin psoriasis without arthrits	Clinical examination, blood sampling, ultrasonic assessment, and questionnaires	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.

Primary Outcome Measures

Name	Time	Method
American college of rheumatology 20%,	4 months from baseline	Composite measures of improvement in disease state (20% improvement)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Parker Institute, Frederiksberg and Bispebjerg Hospital; 🇩🇰 Frederiksberg, Copenhagen, Denmark