Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis

NCT02572700 | Unknown DMC

• 1 other identifier: H-15009080
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis; Psoriasis; Healthy Controls

Keywords

Psoriatic arthritis; Psoriasis; DMARD; Pain; Comorbidities; Ultrasound; Immunology; Patient-reported outcomes

Outcome Measures

Primary Outcomes (1)

• American college of rheumatology 20%,

  Composite measures of improvement in disease state (20% improvement)

  4 months from baseline

Secondary Outcomes (2)

• Disease Activity Index in Psoriatic Arthritis (DAPSA)

  4 months from baseline

• Minimal Disease Activity (MDA)

  4 months from baseline

Other Outcomes (21)

• 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)

  4 months from baseline

Study Arms (3)

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.

Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires

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.

Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires

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.

Other: Clinical examination, blood sampling, ultrasonic assessment, and questionnaires

Interventions

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.

Healthy controls; Patients with psoriatic arthritis; Patients with skin psoriasis without arthrits

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

The Parker Institute, Frederiksberg and Bispebjerg Hospital

Frederiksberg, Copenhagen, 2000, Denmark

RECRUITING

Related Publications (5)

• 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.

  PMID: 35302402 DERIVED

• 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.

  PMID: 34778701 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.

  PMID: 33325531 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.

  PMID: 29975012 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.

  PMID: 27084281 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood are processed for storage in a project biobank including plasma, serum and blood leucocytes for assessment of immune characteristics and mechanisms

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis; Pain

Interventions

Restraint, Physical; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lars Erik Kristensen, MD, Ph.D

  The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zara R Stisen, MD

CONTACT

0045 3816 4178; zara.rebecca.stisen.03@regionh.dk

Marie Skougaard, MD

CONTACT

0045 38164178; marie.skougaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 9, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

DK (1)