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NCT Number: NCT05291819

Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis

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

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF, Bergen, Norway

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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 entheseal disease)
  • Fulfillment of CASPAR criteria for PsA

Exclusion criteria

  • 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

Treatment and study plan

Imaging informed treat-to-target

Other

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 (power Doppler>0 in enthesis) or axial inflammation (SPARCC score ≥ 2* in SI-joint or SPARCC score ≥ 5 in presence of clinical symptoms of axial disease) 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

Conventional treat-to-target

Other

Patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the target in the conventional arm, is all of: Disease Activity index in PSoriatic Arthritis (DAPSA) remission (≤4), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%

Primary outcomes

  1. Sustained Remission

    Time frame: 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 outcomes

  1. Patient global assessment of disease activity

    Time frame: 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

  2. Patient pain assessment

    Time frame: 12 and 24 months

    Patient pain assessment on a 0-100 visual analogue scale, with higher scores Indicating more pain

  3. Patient fatigue assessment

    Time frame: 12 and 24 months

    Patient fatigue assessment on a 0-100 visual analogue scale, with higher scores Indicating more fatigue

  4. 66 joint count for swollen joints

    Time frame: 12 and 24 months

    Structured 66 joint count for swollen joints

  5. 68 joint count for tender joints

    Time frame: 12 and 24 months

    Structured 68 joint count for tender joints

  6. Tender dactylitis count

    Time frame: 12 and 24 months

    Structured tender dactylitis count

  7. Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC entheseal index)

    Time frame: 12 and 24 months

    SPARCC magnetic resonance imaging entheseal index

  8. Body surface area of skin psoriasis

    Time frame: 12 and 24 months

    Body surface area of skin psoriasis in percentage

  9. Modified Nail Psoriasis Severity Index (mNAPSI)

    Time frame: 12 and 24 months

    Modified Nail Psoriasis Severity Index (mNAPSI)

  10. Physician global assessment of disease activity

    Time frame: 12 and 24 months

    Physician global assessment of disease activity on a 0-100 visual analogue scale, with higher scores Indicating more disease activity

  11. C-reactive protein (CRP)

    Time frame: 12 and 24 months

    C-reactive protein (CRP), higher scores indicating more inflammation

  12. Erythrocyte sedimentation rate (ESR)

    Time frame: 12 and 24 months

    Erythrocyte sedimentation rate (ESR), higher scores indicating more inflammation

  13. Disease activity in Psoriatic arthritis Score (DAPSA)

    Time frame: 12 and 24 months

    Disease activity in Psoriatic arthritis Score (DAPSA), higher scores indicating more disease activity

  14. Minimal Disease Activity (MDA)

    Time frame: 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.

  15. Psoriatic Arthritis Disease Activity Score (PASDAS)

    Time frame: 12 and 24 months

    Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite disease activity index, with higher scores indicating more disease activity

  16. American College of Rheumatology (ACR) 20 response

    Time frame: 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.

  17. Structured assessment of joints by musculoskeletal ultrasound according to a predefined protocol

    Time frame: 12 and 24 months

    Structured assessment of joints by musculoskeletal ultrasound according to a predefined protocol

  18. Structured assessment of entheses by musculoskeletal ultrasound according to a predefined protocol

    Time frame: 12 and 24 months

    Structured assessment of entheses by musculoskeletal ultrasound according to a predefined protocol

  19. Structured assessment of tendons by musculoskeletal ultrasound according to a predefined protocol

    Time frame: 12 and 24 months

    Structured assessment of tendons by musculoskeletal ultrasound according to a predefined protocol

  20. Health Related Quality of Life

    Time frame: 12 and 24 months

    Assessed by Short Form 36 (SF-36) questionnaire

  21. Adverse events

    Time frame: 0-24 months

    Number and nature of adverse events and serious adverse events

Other outcomes

  1. Patient global assessment of disease activity

    Time frame: 0-24 months

    Patient global assessment of disease activity on a 0-100 visual analogue scale, with higher scores Indicating more disease activity

  2. Patient pain assessment

    Time frame: 0-24 months

    Patient pain assessment on a 0-100 visual analogue scale, with higher scores Indicating more pain

  3. Patient fatigue assessment

    Time frame: 0-24 months

    Patient fatigue assessment on a 0-100 visual analogue scale, with higher scores Indicating more fatigue

  4. Bath Ankylosing Spondylitis Disease Activity Index

    Time frame: 0-24 months

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), higher scores indicating more disease activity

  5. Patient acceptable symptom state

    Time frame: 0-24 months

    Patient acceptable symptom state (PASS)

  6. 66 joint count for swollen joints

    Time frame: 0-24 months

    66 joint count for swollen joints

  7. 68 joint count for tender joints

    Time frame: 0-24 months

    68 joint count for tender joints

  8. Tender dactylitis count

    Time frame: 0-24 months

    Tender dactylitis count

  9. Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC entheseal index)

    Time frame: 0-24 months

    SPARCC MRI entheseal index

  10. Body surface area of skin psoriasis

    Time frame: 0-24 months

    Body surface area of skin psoriasis in percentages

  11. Investigator global assessment of skin psoriasis

    Time frame: 0-24 months

    Investigator global assessment of skin psoriasis

  12. Modified Nail Psoriasis Severity Index (mNAPSI)

    Time frame: 0-24 months

    Modified Nail Psoriasis Severity Index (mNAPSI)

  13. Physician global assessment of disease activity

    Time frame: 0-24 months

    Physician global assessment of disease activity on a 0-100 visual analogue scale

  14. C-reactive protein (CRP)

    Time frame: 0-24 months

    C-reactive protein (CRP), higher scores indicating more inflammation

  15. Erythrocyte sedimentation rate (ESR)

    Time frame: 0-24 months

    Erythrocyte sedimentation rate (ESR), higher scores indicating more inflammation

  16. Disease activity in Psoriatic arthritis Score (DAPSA)

    Time frame: 0-24 months

    Disease activity in Psoriatic arthritis Score (DAPSA)

  17. Minimal Disease Activity (MDA)

    Time frame: 0-24 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.

  18. Psoriatic Arthritis Disease Activity Score (PASDAS)

    Time frame: 0-24 months

    Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite disease activity index, with higher scores indicating more disease activity

  19. American College of Rheumatology (ACR) response

    Time frame: 0-24 months

    American College of Rheumatology (ACR) response

  20. Disease Activity score 28 (DAS-28)

    Time frame: 0-24 months

    Disease Activity score 28 (DAS-28)

  21. Inflammation assessed musculoskeletal ultrasound

    Time frame: 0 and 24 months

    • Joints (as specified in protocol)
    • Entheses (as specified in protocol)
    • Tendons (as specified in protocol)
    • Peritenonitis (as specified in protocol)

  22. Inflammation assessed by MRI

    Time frame: 12 and 24 months

    MRI of total spine and sacroiliac joint, assessed by SPARCC score

  23. Joint damage assessed by radiography of hands and feet

    Time frame: 24 months

    Assessed by the modified Sharp van der Heijde Score

  24. Work Productivity and Activity Impairment Questionnaire (WPAI)

    Time frame: 0-24 months

    Work Productivity and Activity Impairment Questionnaire (WPAI)

  25. Work participation

    Time frame: 0-24 months

    Work participation based on data from Statistics Norways's event database (FD Trygd) (social benefits)

  26. Euro Quality of Life 5 Dimensions (EQ-5D)

    Time frame: 0-24 months

    Euro Quality of Life 5 Dimensions (EQ-5D)

  27. Short Form 36 (SF-36)

    Time frame: 0-24 months

    Short Form 36 (SF-36)

  28. Psoriatic Arthritis Impact of Disease (PsAID)

    Time frame: 0-24 months

    Psoriatic Arthritis Impact of Disease (PsAID)

  29. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Time frame: 0-24 months

    Health Assessment Questionnaire Disability Index (HAQ-DI)

  30. Use of hospital services

    Time frame: 0-24 months

    Use of hospital services from The Norwegian Patient Register

  31. Medication prescription

    Time frame: 0-24 months

    Prescription of medication from The Norwegian Prescription Register (pharmaceuticals)

  32. Use of primary care resources

    Time frame: 0-24 months

    Use of primary care resources based on data from Norway Control and Payment of Health Reimbursement (KUHR) database (primary care services) (d) Municipal patient- and user register (IPLOS) database (nursing services)

  33. Use of nursing services

    Time frame: 0-24 months

    Use of nursing services based on the municipal patient- and user register (IPLOS) database

Study contacts

Contact information is provided by the study sponsor or research team.

Even Lillejordet, MD

CONTACT

[email protected]

Siri Lillegraven, MD, MPH, PhD

CONTACT

[email protected]

+4722451500

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Official study title

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

Acronym: NOR-SPRINT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2022
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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