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Pain Mechanisms and Ultrasonographic Disease Activity in Psoriatic Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02572700
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Frederiksberg University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Lars Erik Kristensen, MD, Ph.D
Principal Investigator Affiliation The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Denmark
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriatic Arthritis, Psoriasis, Healthy Controls
Additional Details

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.#46; 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

Arms & Interventions

Arms

: 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.

Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Frederiksberg, Copenhagen, Denmark

Status

Recruiting

Address

The Parker Institute, Frederiksberg and Bispebjerg Hospital

Frederiksberg, Copenhagen, 2000

Site Contact

Zara R Stisen, MD

marie.skougaard.nielsen@regionh.dk

38164178 #0045

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