Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis

Psoriasis Clinical Trial

— PIPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02572700
• Other study ID #: H-15009080
• Status: Recruiting
• Start date: September 2015
• Est. completion date: September 2025

Study information

• Verified date: March 2021
• Source: Frederiksberg University Hospital
• Contact: Zara R Stisen, MD
• Phone: 0045 3816 4178
• Email: zara.rebecca.stisen.03[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Healthy Controls
• Psoriasis
• Psoriatic Arthritis

Intervention

Other:
• Clinical 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.

Locations

Country	Name	City	State
Denmark	The Parker Institute, Frederiksberg and Bispebjerg Hospital	Frederiksberg	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in swollen joint count (SJC)		4 months from baseline
Other	Change in tender joint count (TJC)		4 months from baseline
Other	Change in Spondyloarthritis Research Consortium of Canada enthesitis score (SPARCC)		4 months from baseline
Other	Change in The Psoriatic Arthritis Impact of Disease-score (PsAID)		4 months from baseline
Other	Change in Dermatology Life Quality Index (DLQI)		4 months from baseline
Other	Change in Assessment of Motor and Process Skills (AMPS test)		4 months from baseline
Other	Transition Questionnaire score (Trans-Q)	Patient's judgement of overall improvement during treatment	4 months from baseline
Other	Change in PainDETECTquestionnaire score (PDQ)		4 months from baseline
Other	Change in Health Assessment Questionnaire disability index (HAQ)		4 months from baseline
Other	Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue		4 months from baseline
Other	Change in Visual Analogue Scale (VAS) (0-100 mm) of pain		4 months from baseline
Other	Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact		4 months from baseline
Other	Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical health		4 months from baseline
Other	Change in psoriasis area severity index (PASI)		4 months from baseline
Other	Change in ultrasonography joint scores (grey scale and doppler)		4 months from baseline
Other	Change in ultrasonography entheses scores (grey scale and doppler)		4 months from baseline
Other	Change in total cholesterol (mmol/L)		4 months from baseline
Other	Change in body weight (kg)		4 months from baseline
Other	Change in c-reactive protein (mg/L)		4 months from baseline
Other	Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)		4 months from baseline
Other	Change in Bath Ankylosing Spondylitis Functional Index (BASFI)		4 months from baseline
Primary	American college of rheumatology 20%,	Composite measures of improvement in disease state (20% improvement)	4 months from baseline
Secondary	Disease Activity Index in Psoriatic Arthritis (DAPSA)	A composite measure of disease activity	4 months from baseline
Secondary	Minimal Disease Activity (MDA)	A composite measure of disease activity	4 months from baseline