Investigating pain mechanisms and disease activity in psoriatic arthritis
Pain Mechanisms and Ultrasonographic Inflammatory Changes as Prognostic Factors in Patients With Psoriatic Arthritis: a Prospective, Exploratory Cohort Study
This study is trying to understand how pain and inflammation affect people with psoriatic arthritis who are starting or changing their treatment, while also comparing them to those with just skin psoriasis and healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Frederiksberg University Hospital Academic / other |
| Locations | 1 site (Frederiksberg, Copenhagen) |
| Trial ID | NCT02572700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between pain mechanisms, comorbidities, and ultrasonographic inflammatory activity in patients with psoriatic arthritis who are starting or changing their anti-rheumatic treatment. Participants will undergo a series of assessments, including clinical evaluations, pain questionnaires, ultrasonography, and blood sampling, to gather data on their condition. The study will track these patients over a period of four months and beyond to determine how these factors influence treatment outcomes. Additionally, comparisons will be made with patients who have skin psoriasis without arthritis and healthy controls.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with psoriatic arthritis who are initiating or switching their anti-rheumatic treatment due to active disease.
Not a fit: Patients who are pregnant, have peripheral neuropathy, or are currently receiving certain medications that may interfere with the study will not benefit from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with psoriatic arthritis by identifying key factors that influence treatment response.
How similar studies have performed: Other studies have shown success in exploring similar pain mechanisms and treatment responses in rheumatic diseases, indicating that this approach has potential.
Eligibility criteria
Show full 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
Where this trial is running
Frederiksberg, Copenhagen
- The Parker Institute, Frederiksberg and Bispebjerg Hospital — Frederiksberg, Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Lars Erik Kristensen, MD, Ph.D — The Parker Institute, Frederiksberg and Bispebjerg Hospital, Frederiksberg, Denmark
- Study coordinator: Zara R Stisen, MD
- Email: zara.rebecca.stisen.03@regionh.dk
- Phone: 0045 3816 4178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.