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

Last updated: October 3, 2024
Sponsor: Diakonhjemmet Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Psoriasis And Psoriatic Disorders

Arthritis And Arthritic Pain

Psoriatic Arthritis

Treatment

Imaging informed treat-to-target

Conventional treat-to-target

Clinical Study ID

NCT05291819
NOR-SPRINT protocol ver4_1
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (>18 years of age)

  2. Clinical diagnosis of PsA

  3. Indication for treatment with DMARDs according to treating physician (includinghaving 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

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, severediabetes mellitus, severe infections, uncontrolled hypertension, severecardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases andcirrhosis.

  6. Indications of active or latent tuberculosis (TB) as assessed by chest radiographand TB interferon gamma release assay (IGRA). Patients with documented adequatelytreated latent TB can be included.

  7. Any other medical condition that according to the treated physician and/or localguidelines 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 AlanineTransaminase (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 orplanned 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 protocolimpossible

  14. Established or suspected widespread-pain syndrome/fibromyalgia

Study Design

Total Participants: 202
Treatment Group(s): 2
Primary Treatment: Imaging informed treat-to-target
Phase:
Study Start date:
March 14, 2022
Estimated Completion Date:
December 31, 2027

Study 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

Connect with a study center

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

    Bergen, 5021
    Norway

    Active - Recruiting

  • Department of Rheumatology, Drammen Hospital, Vestre Viken HF

    Drammen, 3004
    Norway

    Active - Recruiting

  • Helse Førde

    Førde,
    Norway

    Active - Recruiting

  • Haugesunds Sanitetsforening Revmatismesykehus

    Haugesund, 5504
    Norway

    Active - Recruiting

  • Sørlandet Sykehus

    Kristiansand,
    Norway

    Active - Recruiting

  • Revmatismesykehuset AS

    Lillehammer,
    Norway

    Active - Recruiting

  • Helgelandssykehuset, Mo i Rana

    Mo i Rana, 8613
    Norway

    Active - Recruiting

  • Department of Rheumatology, Diakonhjemmet Hospital

    Oslo, 0319
    Norway

    Active - Recruiting

  • Martina Hansens Hospital AS

    Sandvika, 1306
    Norway

    Active - Recruiting

  • Helse Stavanger

    Stavanger,
    Norway

    Site Not Available

  • University Hospital of Northern Norway

    Tromsø,
    Norway

    Active - Recruiting

  • Department of Rheumatology, St Olavs Hospital HF

    Trondheim, 7006
    Norway

    Active - Recruiting

  • Department of Rheumatology, Helse Møre og Romsdal HF

    Ålesund, 6026
    Norway

    Active - Recruiting

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