Actively Recruiting
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
Eligibility Criteria
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
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
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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