Comparing imaging-based treatment strategies for psoriatic arthritis

A NORwegian Randomized Strategy Trial in PsoRiatic Arthritis: ImagiNg Treat-to-target vs Conventional Treat-to-target

This study is testing if using imaging scans along with regular check-ups can help people with psoriatic arthritis achieve better long-term health results than just regular check-ups alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 202 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Diakonhjemmet Hospital (Academic / other)
• Locations: 12 sites (Ålesund and 11 other locations)
• Trial ID: NCT05291819 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether a treat-to-target strategy that incorporates structured imaging assessments can lead to better patient outcomes, specifically sustained remission, compared to a conventional treat-to-target strategy in patients with psoriatic arthritis. Participants will be randomized into two groups: one receiving standard clinical assessments and the other receiving both clinical and imaging assessments. The primary endpoint is achieving Very Low Disease Activity (VLDA) at 16, 20, and 24 months. Secondary endpoints include various disease activity measures, quality of life assessments, and monitoring of adverse events over a 24-month follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a clinical diagnosis of psoriatic arthritis who require treatment with disease-modifying anti-rheumatic drugs.

Not a fit: Patients with a history of severe comorbidities or those who have previously received DMARD treatment for psoriatic arthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved long-term outcomes and quality of life for patients with psoriatic arthritis.

How similar studies have performed: While the use of imaging in treatment strategies is gaining interest, this specific approach has not been extensively tested in prior studies, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. Adult (\>18 years of age)
2. Clinical diagnosis of PsA
3. Indication for treatment with DMARDs according to treating physician (including having attempted ≥2 non-steroidal anti-inflammatory drugs (NSAIDs) for a minimum of 4 weeks in total in predominantly axial and/or entheseal disease)
4. Fulfillment of CASPAR criteria for PsA

Exclusion Criteria:

1. Verified arthritis \>1 year prior to inclusion
2. Previous DMARD treatment for PsA
3. Systemic glucocorticoid use within the last 3 months
4. Local glucocorticoid injections within the last 4 weeks
5. Major co-morbidities, including but not limited to relevant malignancies, severe diabetes mellitus, severe infections, uncontrolled hypertension, severe cardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases and cirrhosis.
6. Indications of active or latent tuberculosis (TB) as assessed by chest radiograph and TB interferon gamma release assay (IGRA). Patients with documented adequately treated latent TB can be included.
7. Any other medical condition that according to the treated physician and/or local guidelines makes adherence to treatment protocol impossible
8. Abnormal renal function, defined as serum creatinine \>142 µmol/L in female and \>168 µmol/L in male, or estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m2
9. Abnormal liver function (defined as Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) \>1.5 x upper normal limit), active or recent hepatitis
10. Significant anemia, leukopenia and/or thrombocytopenia
11. Inadequate birth control, pregnancy, and/or breastfeeding (current at screening or planned within the duration of the study)
12. Contraindications to magnetic resonance imaging
13. Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
14. Established or suspected widespread-pain syndrome/fibromyalgia

Where this trial is running

Ålesund and 11 other locations

• Department of Rheumatology, Helse Møre og Romsdal HF — Ålesund, Norway (Recruiting)
• Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF — Bergen, Norway (Recruiting)
• Department of Rheumatology, Drammen Hospital, Vestre Viken HF — Drammen, Norway (Recruiting)
• Helse Førde — Førde, Norway (Recruiting)
• Haugesunds Sanitetsforening Revmatismesykehus — Haugesund, Norway (Recruiting)
• Sørlandet Sykehus — Kristiansand, Norway (Recruiting)
• Revmatismesykehuset AS — Lillehammer, Norway (Recruiting)
• Helgelandssykehuset, Mo i Rana — Mo i Rana, Norway (Recruiting)
• Department of Rheumatology, Diakonhjemmet Hospital — Oslo, Norway (Recruiting)
• Martina Hansens Hospital AS — Sandvika, Norway (Recruiting)
• University Hospital of Northern Norway — Tromsø, Norway (Recruiting)
• Department of Rheumatology, St Olavs Hospital HF — Trondheim, Norway (Recruiting)

Study contacts

• Principal investigator: Siri Lillegraven, MD, MPH, PhD — Diakonhjemmet
• Study coordinator: Siri Lillegraven, MD, MPH, PhD

Conditions Psoriatic Arthritis; Imaging; Treat-to-target