- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02572700
Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis (PIPA)
Pain Mechanisms and Ultrasonographic Inflammatory Changes as Prognostic Factors in Patients With Psoriatic Arthritis: a Prospective, Exploratory Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Assessment of pain mechanisms by clinical evaluation (swollen/tender joint ratio, tender points) and pain questionnaires (widespread pain index, PainDETECT).
- Ultrasonography of joints and entheses by two trained assessors
- Clinical examination of all psoriatic manifestations
- Interview and questionnaires regarding lifestyle, comorbidity status, function, quality of life and the impact of psoriatic manifestations.
- Blood samples for standard rheumatic monitoring and biobank
- X-ray of hands and feet (only at baseline)
- 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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Zara R Stisen, MD
- Phone Number: 0045 3816 4178
- Email: zara.rebecca.stisen.03@regionh.dk
Study Contact Backup
- Name: Marie Skougaard, MD
- Phone Number: 0045 38164178
- Email: marie.skougaard@regionh.dk
Study Locations
-
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Copenhagen
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Frederiksberg, Copenhagen, Denmark, 2000
- Recruiting
- The Parker Institute, Frederiksberg and Bispebjerg Hospital
-
Contact:
- Zara R Stisen, MD
- Phone Number: 0045 38164178
- Email: marie.skougaard.nielsen@regionh.dk
-
Contact:
- Lars Erik Kristensen, MD, phd
- Phone Number: 0045 38164157
- Email: lars.erik.kristensen@regionh.dk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
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Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact
Time Frame: 4 months from baseline
|
4 months from baseline
|
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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
|
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Change in psoriasis area severity index (PASI)
Time Frame: 4 months from baseline
|
4 months from baseline
|
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Change in ultrasonography joint scores (grey scale and doppler)
Time Frame: 4 months from baseline
|
4 months from baseline
|
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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
|
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Change in body weight (kg)
Time Frame: 4 months from baseline
|
4 months from baseline
|
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Change in c-reactive protein (mg/L)
Time Frame: 4 months from baseline
|
4 months from baseline
|
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Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: 4 months from baseline
|
4 months from baseline
|
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Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: 4 months from baseline
|
4 months from baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lars Erik Kristensen, MD, Ph.D, The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark
Publications and helpful links
General Publications
- 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. 2022 Mar 18:1-9. doi: 10.1080/03009742.2022.2044116. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-15009080
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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