Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05291819

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

Led by Diakonhjemmet Hospital · Updated on 2024-10-04

202

Participants Needed

12

Research Sites

302 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years of age
  • Clinical diagnosis of psoriatic arthritis
  • Fulfillment of CASPAR criteria for psoriatic arthritis
  • Indication for treatment with disease modifying anti-rheumatic drugs (DMARDs) as decided by the treating physician
  • Have tried at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) for a total of 4 weeks or more if mainly axial and/or enthesitis disease is present
Not Eligible

You will not qualify if you...

  • Verified arthritis diagnosed more than 1 year before joining the study
  • Previous treatment with DMARDs for psoriatic arthritis
  • Use of systemic glucocorticoids within the last 3 months
  • Local glucocorticoid injections within the last 4 weeks
  • Major health problems such as relevant cancers, severe diabetes, severe infections, uncontrolled high blood pressure, severe heart or lung diseases, or liver cirrhosis
  • Signs of active or latent tuberculosis unless adequately treated
  • Any medical condition that makes following the treatment plan impossible
  • Poor kidney function defined by specific creatinine or eGFR levels
  • Poor liver function or active/recent hepatitis
  • Significant anemia, low white blood cells, or low platelets
  • Inadequate birth control, pregnancy, or breastfeeding during the study
  • Contraindications to magnetic resonance imaging (MRI)
  • Severe psychiatric or mental disorders, substance abuse, language barriers, or other factors preventing study participation
  • Established or suspected widespread pain syndrome or fibromyalgia

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Department of Rheumatology, Helse Møre og Romsdal HF

Ålesund, Norway, 6026

Actively Recruiting

2

Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF

Bergen, Norway, 5021

Actively Recruiting

3

Department of Rheumatology, Drammen Hospital, Vestre Viken HF

Drammen, Norway, 3004

Actively Recruiting

4

Helse Førde

Førde, Norway

Actively Recruiting

5

Haugesunds Sanitetsforening Revmatismesykehus

Haugesund, Norway, 5504

Actively Recruiting

6

Sørlandet Sykehus

Kristiansand, Norway

Actively Recruiting

7

Revmatismesykehuset AS

Lillehammer, Norway

Actively Recruiting

8

Helgelandssykehuset, Mo i Rana

Mo i Rana, Norway, 8613

Actively Recruiting

9

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, Norway, 0319

Actively Recruiting

10

Martina Hansens Hospital AS

Sandvika, Norway, 1306

Actively Recruiting

11

University Hospital of Northern Norway

Tromsø, Norway

Actively Recruiting

12

Department of Rheumatology, St Olavs Hospital HF

Trondheim, Norway, 7006

Actively Recruiting

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Research Team

S

Siri Lillegraven, MD, MPH, PhD

CONTACT

E

Even Lillejordet, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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