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

NCT05291819 | Recruiting DMC

• 1 other identifier: NOR-SPRINT protocol ver4_1
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 12

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

Conditions

Psoriatic Arthritis

Keywords

Imaging; Treat-to-target

Outcome Measures

Primary Outcomes (1)

• Sustained Remission

  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.

  Sustained remission is defined by the patient meeting VLDA at all of 16, 20 and 24 month follow-up visits

Secondary Outcomes (21)

• Patient global assessment of disease activity

  12 and 24 months

• Patient pain assessment

  12 and 24 months

• Patient fatigue assessment

  12 and 24 months

• 66 joint count for swollen joints

  12 and 24 months

• 68 joint count for tender joints

  12 and 24 months

Other Outcomes (33)

• Patient global assessment of disease activity

  0-24 months

• Patient pain assessment

  0-24 months

• Patient fatigue assessment

  0-24 months

Study Arms (2)

Conventional treat-to-target

OTHER

Conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity

Other: Conventional treat-to-target

Imaging informed treat-to-target

EXPERIMENTAL

Imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity.

Other: Imaging informed treat-to-target

Interventions

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

Imaging informed treat-to-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%

Conventional treat-to-target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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) for a minimum of 4 weeks in total in predominantly axial and/or entheseal disease)
• Fulfillment of CASPAR criteria for PsA

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (12)

Department of Rheumatology, Helse Møre og Romsdal HF

Ålesund, 6026, Norway

RECRUITING

Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF

Bergen, 5021, Norway

RECRUITING

Department of Rheumatology, Drammen Hospital, Vestre Viken HF

Drammen, 3004, Norway

RECRUITING

Helse Førde

Førde, Norway

RECRUITING

Haugesunds Sanitetsforening Revmatismesykehus

Haugesund, 5504, Norway

RECRUITING

Sørlandet Sykehus

Kristiansand, Norway

RECRUITING

Revmatismesykehuset AS

Lillehammer, Norway

RECRUITING

Helgelandssykehuset, Mo i Rana

Mo i Rana, 8613, Norway

RECRUITING

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, 0319, Norway

RECRUITING

Martina Hansens Hospital AS

Sandvika, 1306, Norway

RECRUITING

University Hospital of Northern Norway

Tromsø, Norway

RECRUITING

Department of Rheumatology, St Olavs Hospital HF

Trondheim, 7006, Norway

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Siri Lillegraven, MD, MPH, PhD

  Diakonhjemmet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siri Lillegraven, MD, MPH, PhD

CONTACT

+4722451500; siri.lillegraven@diakonsyk.no

Even Lillejordet, MD

CONTACT

even.lillejordet@diakonsyk.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 23, 2022
• Study Start: March 14, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

NO (12)