Clinical trial NCT02572700: Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis
Official title: Pain Mechanisms and Ultrasonographic Inflammatory Changes as Prognostic Factors in Patients With Psoriatic Arthritis: a Prospective, Exploratory Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriatic Arthritis
Psoriasis
Healthy Controls
Keywords: Psoriatic arthritis
Psoriasis
DMARD
Pain
Comorbidities
Ultrasound
Immunology
Patient-reported outcomes
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \> 18 years of age with PsA according to the CASPAR criteria who initiate or switch anti-rheumatic treatment (biologics and/or conventional synthetic DMARDs) due to active PsA in routine care.

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

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

Primary outcomes:
measure: American college of rheumatology 20%,
timeFrame: 4 months from baseline
Secondary outcomes:
measure: Disease Activity Index in Psoriatic Arthritis (DAPSA)
timeFrame: 4 months from baseline
measure: Minimal Disease Activity (MDA)
timeFrame: 4 months from baseline
Other outcomes:
measure: Change in swollen joint count (SJC)
timeFrame: 4 months from baseline
measure: Change in tender joint count (TJC)
timeFrame: 4 months from baseline
measure: Change in Spondyloarthritis Research Consortium of Canada enthesitis score (SPARCC)
timeFrame: 4 months from baseline
measure: Change in The Psoriatic Arthritis Impact of Disease-score (PsAID)
timeFrame: 4 months from baseline
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: 4 months from baseline
measure: Change in Assessment of Motor and Process Skills (AMPS test)
timeFrame: 4 months from baseline
measure: Transition Questionnaire score (Trans-Q)
timeFrame: 4 months from baseline
measure: Change in PainDETECTquestionnaire score (PDQ)
timeFrame: 4 months from baseline
measure: Change in Health Assessment Questionnaire disability index (HAQ)
timeFrame: 4 months from baseline
measure: Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue
timeFrame: 4 months from baseline
measure: Change in Visual Analogue Scale (VAS) (0-100 mm) of pain
timeFrame: 4 months from baseline
measure: Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact
timeFrame: 4 months from baseline
measure: Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical health
timeFrame: 4 months from baseline
measure: Change in psoriasis area severity index (PASI)
timeFrame: 4 months from baseline
measure: Change in ultrasonography joint scores (grey scale and doppler)
timeFrame: 4 months from baseline
measure: Change in ultrasonography entheses scores (grey scale and doppler)
timeFrame: 4 months from baseline
measure: Change in total cholesterol (mmol/L)
timeFrame: 4 months from baseline
measure: Change in body weight (kg)
timeFrame: 4 months from baseline
measure: Change in c-reactive protein (mg/L)
timeFrame: 4 months from baseline
measure: Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: 4 months from baseline
measure: Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 4 months from baseline
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute, Frederiksberg and Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark
name: Lars Erik Kristensen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skougaard M, Stisen ZR, Jorgensen TS, Egeberg A, Hansen RL, Perez-Chada LM, Mogensen M, Merola JF, Gerwien JG, Kristensen LE. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2023 May;52(3):259-267. doi: 10.1080/03009742.2022.2044116. Epub 2022 Mar 18.
citation: Skougaard M, Jorgensen TS, Jensen MJ, Ballegaard C, Guldberg-Moller J, Egeberg A, Christensen R, Benzin P, Stisen ZR, Merola JF, Coates LC, Strand V, Mease P, Kristensen LE. Change in psoriatic arthritis outcome measures impacts SF-36 physical and mental component scores differently: an observational cohort study. Rheumatol Adv Pract. 2021 Nov 2;5(3):rkab076. doi: 10.1093/rap/rkab076. eCollection 2021.
citation: Ballegaard C, Skougaard M, Guldberg-Moller J, Nissen CV, Amris K, Jorgensen TS, Dreyer L, Kristensen LE. Comorbidities, pain and fatigue in psoriatic arthritis, psoriasis and healthy controls: a clinical cohort study. Rheumatology (Oxford). 2021 Jul 1;60(7):3289-3300. doi: 10.1093/rheumatology/keaa780.
citation: Hojgaard P, Ellegaard K, Nielsen SM, Christensen R, Guldberg-Moller J, Ballegaard C, Dreyer L, Mease P, de Wit M, Skov L, Glintborg B, Bliddal H, Bartels EM, Amris K, Kristensen LE. Pain Mechanisms and Ultrasonic Inflammatory Activity as Prognostic Factors in Patients With Psoriatic Arthritis: A Prospective Cohort Study. Arthritis Care Res (Hoboken). 2019 Jun;71(6):798-810. doi: 10.1002/acr.23693. Epub 2019 May 2.
citation: Hojgaard P, Christensen R, Dreyer L, Mease P, de Wit M, Skov L, Glintborg B, Christensen AW, Ballegaard C, Bliddal H, Bukhave K, Bartels EM, Amris K, Ellegaard K, Kristensen LE. Pain mechanisms and ultrasonic inflammatory activity as prognostic factors in patients with psoriatic arthritis: protocol for a prospective, exploratory cohort study. BMJ Open. 2016 Apr 15;6(4):e010650. doi: 10.1136/bmjopen-2015-010650.