Status:
RECRUITING
Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis
Lead Sponsor:
Diakonhjemmet Hospital
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective is to assess if a treat-to-target strategy implementing structured imaging assessments leads to better patient outcome in terms of sustained remission compared to a conventional tre...
Detailed Description
This project addresses the challenges associated with psoriatic arthritis (PsA), which is a diverse disease which is difficult to assess clinically. Ultrasound and magnetic resonance imaging (MRI) vis...
Eligibility Criteria
Inclusion
- Adult (\>18 years of age)
- Clinical diagnosis of PsA
- 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)
- Fulfillment of CASPAR criteria for PsA
Exclusion
- Verified arthritis \>1 year prior to inclusion
- Previous DMARD treatment for PsA
- Systemic glucocorticoid use within the last 3 months
- Local glucocorticoid injections within the last 4 weeks
- 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.
- 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.
- Any other medical condition that according to the treated physician and/or local guidelines makes adherence to treatment protocol impossible
- 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
- Abnormal liver function (defined as Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) \>1.5 x upper normal limit), active or recent hepatitis
- Significant anemia, leukopenia and/or thrombocytopenia
- Inadequate birth control, pregnancy, and/or breastfeeding (current at screening or planned within the duration of the study)
- Contraindications to magnetic resonance imaging
- Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
- Established or suspected widespread-pain syndrome/fibromyalgia
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT05291819
Start Date
March 14 2022
End Date
December 31 2027
Last Update
October 4 2024
Active Locations (12)
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1
Department of Rheumatology, Helse Møre og Romsdal HF
Ålesund, Norway, 6026
2
Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF
Bergen, Norway, 5021
3
Department of Rheumatology, Drammen Hospital, Vestre Viken HF
Drammen, Norway, 3004
4
Helse Førde
Førde, Norway