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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical examination, blood sampling, ultrasonic assessment, and questionnaires | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| American college of rheumatology 20%, | Composite measures of improvement in disease state (20% improvement) | 4 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Index in Psoriatic Arthritis (DAPSA) | A composite measure of disease activity | 4 months from baseline |
| Minimal Disease Activity (MDA) | A composite measure of disease activity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in swollen joint count (SJC) | 4 months from baseline | |
| Change in tender joint count (TJC) | 4 months from baseline | |
| Change in Spondyloarthritis Research Consortium of Canada enthesitis score (SPARCC) |
Inclusion Criteria:
Exclusion Criteria:
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> 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zara R Stisen, MD | Contact | 0045 3816 4178 | zara.rebecca.stisen.03@regionh.dk | |
| Marie Skougaard, MD | Contact | 0045 38164178 | marie.skougaard@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lars Erik Kristensen, MD, Ph.D | The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute, Frederiksberg and Bispebjerg Hospital | Recruiting | Frederiksberg | Copenhagen | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35302402 | Derived | 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. | |
| 34778701 |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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Blood are processed for storage in a project biobank including plasma, serum and blood leucocytes for assessment of immune characteristics and mechanisms
|
| 4 months from baseline |
| 4 months from baseline |
| Change in The Psoriatic Arthritis Impact of Disease-score (PsAID) | 4 months from baseline |
| Change in Dermatology Life Quality Index (DLQI) | 4 months from baseline |
| Change in Assessment of Motor and Process Skills (AMPS test) | 4 months from baseline |
| Transition Questionnaire score (Trans-Q) | Patient's judgement of overall improvement during treatment | 4 months from baseline |
| Change in PainDETECTquestionnaire score (PDQ) | 4 months from baseline |
| Change in Health Assessment Questionnaire disability index (HAQ) | 4 months from baseline |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue | 4 months from baseline |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of pain | 4 months from baseline |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact | 4 months from baseline |
| Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical health | 4 months from baseline |
| Change in psoriasis area severity index (PASI) | 4 months from baseline |
| Change in ultrasonography joint scores (grey scale and doppler) | 4 months from baseline |
| Change in ultrasonography entheses scores (grey scale and doppler) | 4 months from baseline |
| Change in total cholesterol (mmol/L) | 4 months from baseline |
| Change in body weight (kg) | 4 months from baseline |
| Change in c-reactive protein (mg/L) | 4 months from baseline |
| Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 4 months from baseline |
| Change in Bath Ankylosing Spondylitis Functional Index (BASFI) | 4 months from baseline |
| 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. |
| 33325531 | Derived | 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. |
| 29975012 | Derived | 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. |
| 27084281 | Derived | 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. |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013048 |
| Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |