Comparing imaging-based treatment strategies for psoriatic arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Siri Lillegraven, MD, MPH, PhD — Diakonhjemmet
• Study coordinator: Siri Lillegraven, MD, MPH, PhD
• Email: siri.lillegraven@diakonsyk.no
• Phone: +4722451500

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.