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

March 3, 2021 updated by: Henning Bliddal, Frederiksberg University Hospital

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

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with psoriatic arthritis
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.
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.
Patients with skin psoriasis without arthrits
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.
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.
Healthy controls
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American college of rheumatology 20%,
Time Frame: 4 months from baseline
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)
Time Frame: 4 months from baseline
A composite measure of disease activity
4 months from baseline
Minimal Disease Activity (MDA)
Time Frame: 4 months from baseline
A composite measure of disease activity
4 months from baseline

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lars Erik Kristensen, MD, Ph.D, The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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