Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis
- Conditions
- Psoriatic Arthritis
- Interventions
- Other: Conventional treat-to-targetOther: Imaging informed treat-to-target
- Registration Number
- NCT05291819
- Lead Sponsor
- Diakonhjemmet Hospital
- 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 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.
Study design: A two-arm, parallel-group, single-blind, treatment strategy study where patients are randomized 1:1 to a conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity or an imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity. Duration of follow-up is 24 months.
All patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the sole target in the conventional arm, is all of: Disease Activity index in Psoriatic Arthritis (DAPSA) remission (≤3), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%
Intervention: A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information. Specifically, this means that these additional measures will be added to conventional treat to target:
* If evidence of enthesitis or axial inflammation on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm
* If evidence of ongoing inflammation (power Doppler\>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target
- 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) visualize inflammation that is not apparent on clinical examination, but whether treating patients according to these findings improves outcomes is unknown.
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.
Primary endpoint: Sustained remission, defined as Very Low Disease Activity (VLDA) at all of the 16, 20 and 24 month visits.
Secondary endpoints include Individual and composite disease activity measures and remission criteria, inflammation assessed by ultrasound, health related quality of life and adverse events.
Study design: A two-arm, parallel-group, single-blind, treatment strategy study where patients are randomized 1:1 to a conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity or an imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity. Duration of follow-up is 24 months.
All patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the sole target in the conventional arm, is all of: Disease Activity index in Psoriatic Arthritis (DAPSA) remission (≤3), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%
Intervention: A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information. Specifically, this means that these additional measures will be added to conventional treat to target:
If evidence of enthesitis or axial inflammation on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm If evidence of ongoing inflammation (power Doppler\>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 202
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional treat-to-target Conventional treat-to-target Conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity Imaging informed treat-to-target Imaging informed treat-to-target Imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity.
- Primary Outcome Measures
Name Time Method Sustained Remission Sustained remission is defined by the patient meeting VLDA at all of 16, 20 and 24 month follow-up visits Sustained remission defined as a combination of Very Low Disease Activity (VLDA) at all of the time points 16, 20 and 24 months.
VLDA requires all of the following to be met: Tender joint count (68) ≤ 1, swollen joint count (66) ≤ 1, Psoriasis Body Surface Area ≤ 3, Enthesitis≤ 1, Patient global assessment of disease severity VAS (0-100) ≤ 20, Pain VAS (0-100) ≤ 15 and Health Assessment Questionnaire Disability Index ≤ 0.5.
- Secondary Outcome Measures
Name Time Method Patient fatigue assessment 12 and 24 months Patient fatigue assessment on a 0-100 visual analogue scale, with higher scores Indicating more fatigue
Patient global assessment of disease activity 12 and 24 months Patient global assessment of disease activity on a 0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity
Patient pain assessment 12 and 24 months Patient pain assessment on a 0-100 visual analogue scale, with higher scores Indicating more pain
66 joint count for swollen joints 12 and 24 months Structured 66 joint count for swollen joints
68 joint count for tender joints 12 and 24 months Structured 68 joint count for tender joints
Body surface area of skin psoriasis 12 and 24 months Body surface area of skin psoriasis in percentage
Psoriatic Arthritis Disease Activity Score (PASDAS) 12 and 24 months Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite disease activity index, with higher scores indicating more disease activity
Tender dactylitis count 12 and 24 months Structured tender dactylitis count
Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC entheseal index) 12 and 24 months SPARCC magnetic resonance imaging entheseal index
Modified Nail Psoriasis Severity Index (mNAPSI) 12 and 24 months Modified Nail Psoriasis Severity Index (mNAPSI)
Physician global assessment of disease activity 12 and 24 months Physician global assessment of disease activity on a 0-100 visual analogue scale, with higher scores Indicating more disease activity
Minimal Disease Activity (MDA) 12 and 24 months Minimal Disease Activity (MDA). MDA is a composite assessment of disease activity state in PsA. It includes 7 components: tender joint count (68) ≤ 1, swollen joint count (66) ≤ 1, Psoriasis Area Severity Index ≤ 1/Body Surface Area ≤ 3, enthesitis≤ 1, patient global assessment of disease activity VAS ≤ 20, pain VAS ≤ 15 and HAQ-DI ≤ 0.5. MDA requires 5 out of 7 components to be met.
C-reactive protein (CRP) 12 and 24 months C-reactive protein (CRP), higher scores indicating more inflammation
Erythrocyte sedimentation rate (ESR) 12 and 24 months Erythrocyte sedimentation rate (ESR), higher scores indicating more inflammation
Disease activity in Psoriatic arthritis Score (DAPSA) 12 and 24 months Disease activity in Psoriatic arthritis Score (DAPSA), higher scores indicating more disease activity
American College of Rheumatology (ACR) 20 response 12 and 24 months American College of Rheumatology (ACR) 20 response is defined as ≥ 20 % improvement in swollen and tender joint counts plus ≥ 20 % improvement in 3 of the 5 remaining ACR core set variables; pain VAS, physician global VAS, Health Assessment Questionnaire Disability Index (HAQ-DI) and CRP/ESR.
Structured assessment of joints by musculoskeletal ultrasound according to a predefined protocol 12 and 24 months Structured assessment of joints by musculoskeletal ultrasound according to a predefined protocol
Structured assessment of entheses by musculoskeletal ultrasound according to a predefined protocol 12 and 24 months Structured assessment of entheses by musculoskeletal ultrasound according to a predefined protocol
Structured assessment of tendons by musculoskeletal ultrasound according to a predefined protocol 12 and 24 months Structured assessment of tendons by musculoskeletal ultrasound according to a predefined protocol
Health Related Quality of Life 12 and 24 months Assessed by Short Form 36 (SF-36) questionnaire
Adverse events 0-24 months Number and nature of adverse events and serious adverse events
Trial Locations
- Locations (12)
Sørlandet Sykehus
🇳🇴Kristiansand, Norway
Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF
🇳🇴Bergen, Norway
Department of Rheumatology, Drammen Hospital, Vestre Viken HF
🇳🇴Drammen, Norway
Helse Førde
🇳🇴Førde, Norway
Haugesunds Sanitetsforening Revmatismesykehus
🇳🇴Haugesund, Norway
Revmatismesykehuset AS
🇳🇴Lillehammer, Norway
Helgelandssykehuset, Mo i Rana
🇳🇴Mo i Rana, Norway
Department of Rheumatology, Diakonhjemmet Hospital
🇳🇴Oslo, Norway
Martina Hansens Hospital AS
🇳🇴Sandvika, Norway
University Hospital of Northern Norway
🇳🇴Tromsø, Norway
Department of Rheumatology, St Olavs Hospital HF
🇳🇴Trondheim, Norway
Department of Rheumatology, Helse Møre og Romsdal HF
🇳🇴Ålesund, Norway