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Compares treatment options for Psoriatic Arthritis
Official title Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis
ClinicalTrials.gov ID: NCT05291819
What this study is testing
- What it's testing
- 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 treat-to-target strategy in psoriatic arthritis. Main inclusion criteria are: \>18 years of age, Clinical diagnosis of psoriatic arthritis (PsA), Fulfillment of ClASsification of Psoriatic Arthritis (CASPAR) criteria, Indication for treatment with disease modifying anti-rheumatic drugs according to treating physician Primary endpoint: Sustained remission, defined as Very Low Disease Activity (VLDA) at 16, 20 and 24 months Secondary endpoints: Individual and composite disease activity measures and remission criteria, inflammation assessed by ultrasound, health related quality of life and adverse events.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- Fulfillment of CASPAR criteria for PsA
You likely can't join if
- 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...
- Indications of active or latent tuberculosis (TB) as assessed by chest radiograph and TB interferon gamma release assay (IGRA). Patients with...
See the full eligibility criteria
- 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...
- Fulfillment of CASPAR criteria for PsA
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ålesund, Norway
- Bergen, Norway
- Drammen, Norway
- Førde, Norway
- Haugesund, Norway
- Kristiansand, Norway
- Lillehammer, Norway
- Mo i Rana, Norway
- Oslo, Norway
- Sandvika, Norway
- Tromsø, Norway
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ålesund, Norway; Bergen, Norway; Drammen, Norway; Førde, Norway; Haugesund, Norway; Kristiansand, Norway and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.