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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Department of Rheumatology, Helse Møre og Romsdal HF
RECRUITING
Ålesund
Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF
RECRUITING
Bergen
Department of Rheumatology, Drammen Hospital, Vestre Viken HF
RECRUITING
Drammen
Helse Førde
RECRUITING
Førde
Haugesunds Sanitetsforening Revmatismesykehus
RECRUITING
Haugesund
Sørlandet Sykehus
RECRUITING
Kristiansand
Revmatismesykehuset AS
RECRUITING
Lillehammer
Helgelandssykehuset, Mo i Rana
RECRUITING
Mo I Rana
Department of Rheumatology, Diakonhjemmet Hospital
RECRUITING
Oslo
Martina Hansens Hospital AS
RECRUITING
Sandvika
University Hospital of Northern Norway
RECRUITING
Tromsø
Department of Rheumatology, St Olavs Hospital HF
RECRUITING
Trondheim
Contact Information
Primary
Siri Lillegraven, MD, MPH, PhD
siri.lillegraven@diakonsyk.no
+4722451500
Backup
Even Lillejordet, MD
even.lillejordet@diakonsyk.no
Time Frame
Start Date: 2022-03-14
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 202
Treatments
Other: Conventional treat-to-target
Conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity
Experimental: Imaging informed treat-to-target
Imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity.
Related Therapeutic Areas
Sponsors
Leads: Diakonhjemmet Hospital

This content was sourced from clinicaltrials.gov