Psoriatic ArthritisNOR-SPRINTNCT05291819
Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis
A study testing Imaging informed treat-to-target and Conventional treat-to-target in people with Psoriatic Arthritis, run by Diakonhjemmet Hospital at 12 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Imaging informed treat-to-target and Conventional treat-to-target
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 12 sitesNorway
- Study dates
- 14 Mar 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Verified arthritis >1 year prior to inclusion
- 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.
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- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Even Lillejordet, MD contact
12 sites in 1 country
Norway12 sites, 12 recruiting
- Recruiting
Department of Rheumatology, Helse Møre og Romsdal HF
Ålesund, 6026
Maud-Kristine Aga Ljoså, MD
- Recruiting
Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF
Bergen, 5021
Bjørg-Tilde Fevang, MD PhD
- Recruiting
Department of Rheumatology, Drammen Hospital, Vestre Viken HF
Drammen, 3004
Ada S. Wierød, MD
- Recruiting
Helse Førde
Førde
Anja Myhre Hjelle, MD, PhD
- Recruiting
Haugesunds Sanitetsforening Revmatismesykehus
Haugesund, 5504
Mathias M Braaten, MD
- Recruiting
Sørlandet Sykehus
Kristiansand
Jintana B Andersen, MD PhD
- Recruiting
Revmatismesykehuset AS
Lillehammer
Yi Hu, MD, PhD, Yi.Hu@revmatismesykehuset.no
- Recruiting
Helgelandssykehuset, Mo i Rana
Mo i Rana, 8613
Inger M Hansen, MD
- Recruiting
Department of Rheumatology, Diakonhjemmet Hospital
Oslo, 0319
Even Lillejordet, MD, +22451500, even.lillejordet@diakonsyk.no
- Recruiting
Martina Hansens Hospital AS
Sandvika, 1306
Annicken Slagsvold, MD
- Recruiting
University Hospital of Northern Norway
Tromsø
Gunnstein Bakland, MD, PhD
- Recruiting
Department of Rheumatology, St Olavs Hospital HF
Trondheim, 7006
Agnete Malm Gulati, MD, PhD
About this study
Official title: A NORwegian Randomized Strategy Trial in PsoRiatic Arthritis: ImagiNg Treat-to-target vs Conventional Treat-to-target
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
Read more
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
Read the detailed 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
- Conditions
- Psoriatic Arthritis
- Being tested
- Imaging informed treat-to-target, Conventional treat-to-target
- Keywords
- Imaging, Treat-to-target
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging informed treat-to-targetOther
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
Conventional treat-to-targetOther
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%
| Study group | Role | What they receive |
|---|---|---|
| Conventional treat-to-target | Other | Conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity Receives: 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. Receives: Other: Imaging informed treat-to-target |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Patient global assessment of disease activity on a 0-100 visual analogue scale (VAS), with higher scores Indicating more disease activity
Measured: 12 and 24 months
Patient pain assessment
Patient pain assessment on a 0-100 visual analogue scale, with higher scores Indicating more pain
Measured: 12 and 24 months
Patient fatigue assessment
Patient fatigue assessment on a 0-100 visual analogue scale, with higher scores Indicating more fatigue
Measured: 12 and 24 months
66 joint count for swollen joints
Structured 66 joint count for swollen joints
Measured: 12 and 24 months
68 joint count for tender joints
Structured 68 joint count for tender joints
Measured: 12 and 24 months
Tender dactylitis count
Structured tender dactylitis count
Measured: 12 and 24 months
Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC entheseal index)
SPARCC magnetic resonance imaging entheseal index
Measured: 12 and 24 months
Body surface area of skin psoriasis
Body surface area of skin psoriasis in percentage
Measured: 12 and 24 months
Modified Nail Psoriasis Severity Index (mNAPSI)
Modified Nail Psoriasis Severity Index (mNAPSI)
Measured: 12 and 24 months
Physician global assessment of disease activity
Physician global assessment of disease activity on a 0-100 visual analogue scale, with higher scores Indicating more disease activity
Measured: 12 and 24 months
C-reactive protein (CRP)
C-reactive protein (CRP), higher scores indicating more inflammation
Measured: 12 and 24 months
Erythrocyte sedimentation rate (ESR)
Erythrocyte sedimentation rate (ESR), higher scores indicating more inflammation
Measured: 12 and 24 months
Disease activity in Psoriatic arthritis Score (DAPSA)
Disease activity in Psoriatic arthritis Score (DAPSA), higher scores indicating more disease activity
Measured: 12 and 24 months
Minimal Disease Activity (MDA)
Minimal Disease Activity (MDA). MDA is a composite assessment of disease activity state in PsA. It includes 7 components: tender joint count (68) ≤ 1, swollen joint count (66) ≤ 1, Psoriasis Area Severity Index ≤ 1/Body Surface Area ≤ 3, enthesitis≤ 1, patient global assessment of disease activity VAS ≤ 20, pain VAS ≤ 15 and HAQ-DI ≤ 0.5. MDA requires 5 out of 7 components to be met.
Measured: 12 and 24 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite disease activity index, with higher scores indicating more disease activity
Measured: 12 and 24 months
American College of Rheumatology (ACR) 20 response
American College of Rheumatology (ACR) 20 response is defined as ≥ 20 % improvement in swollen and tender joint counts plus ≥ 20 % improvement in 3 of the 5 remaining ACR core set variables; pain VAS, physician global VAS, Health Assessment Questionnaire Disability Index (HAQ-DI) and CRP/ESR.
Measured: 12 and 24 months
Structured assessment of joints by musculoskeletal ultrasound according to a predefined protocol
Structured assessment of joints by musculoskeletal ultrasound according to a predefined protocol
Measured: 12 and 24 months
Structured assessment of entheses by musculoskeletal ultrasound according to a predefined protocol
Structured assessment of entheses by musculoskeletal ultrasound according to a predefined protocol
Measured: 12 and 24 months
Structured assessment of tendons by musculoskeletal ultrasound according to a predefined protocol
Structured assessment of tendons by musculoskeletal ultrasound according to a predefined protocol
Measured: 12 and 24 months
Health Related Quality of Life
Assessed by Short Form 36 (SF-36) questionnaire
Measured: 12 and 24 months
Adverse events
Number and nature of adverse events and serious adverse events
Measured: 0-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start14 Mar 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siri Lillegraven, Diakonhjemmet Hospital
- Investigators
- Siri Lillegraven, MD, MPH, PhD, Principal investigator, Diakonhjemmet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291819
- Sponsor's protocol ID
- NOR-SPRINT protocol ver4_1
- Acronym
- NOR-SPRINT
- Status last verified
- Oct 2024
- First submitted
- 2 Mar 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A NORwegian Randomized Strategy Trial in PsoRiatic Arthritis: ImagiNg Treat-to-target vs Conventional Treat-to-target
- ClinicalTrials.gov ID
- NCT05291819
- Acronym / sponsor ID
- NOR-SPRINT / NOR-SPRINT protocol ver4_1
- Conditions
- Psoriatic Arthritis
- Keywords
- Imaging, Treat-to-target
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional treat-to-target | Other | Other: Conventional treat-to-targetConventional treat-to-target follow-up strategy with structured clinical assessment of disease activity |
| Imaging informed treat-to-target | Experimental | Other: Imaging informed treat-to-targetImaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Verified arthritis >1 year prior to inclusion
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging informed treat-to-targetA 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 | Other | Imaging informed treat-to-target |
| Conventional treat-to-targetPatients 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% | Other | Conventional treat-to-target |
Primary outcome
Sustained Remission
Time frame: Sustained remission is defined by the patient meeting VLDA at all of 16, 20 and 24 month follow-up visits
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.
21 secondary outcomes
Patient global assessment of disease activity
Time frame: 12 and 24 months
Patient pain assessment
Time frame: 12 and 24 months
Patient fatigue assessment
Time frame: 12 and 24 months
66 joint count for swollen joints
Time frame: 12 and 24 months
68 joint count for tender joints
Time frame: 12 and 24 months
Tender dactylitis count
Time frame: 12 and 24 months
Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC entheseal index)
Time frame: 12 and 24 months
Body surface area of skin psoriasis
Time frame: 12 and 24 months
Modified Nail Psoriasis Severity Index (mNAPSI)
Time frame: 12 and 24 months
Physician global assessment of disease activity
Time frame: 12 and 24 months
C-reactive protein (CRP)
Time frame: 12 and 24 months
Erythrocyte sedimentation rate (ESR)
Time frame: 12 and 24 months
Disease activity in Psoriatic arthritis Score (DAPSA)
Time frame: 12 and 24 months
Minimal Disease Activity (MDA)
Time frame: 12 and 24 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Time frame: 12 and 24 months
American College of Rheumatology (ACR) 20 response
Time frame: 12 and 24 months
Structured assessment of joints by musculoskeletal ultrasound according to a predefined protocol
Time frame: 12 and 24 months
Structured assessment of entheses by musculoskeletal ultrasound according to a predefined protocol
Time frame: 12 and 24 months
Structured assessment of tendons by musculoskeletal ultrasound according to a predefined protocol
Time frame: 12 and 24 months
Health Related Quality of Life
Time frame: 12 and 24 months
Adverse events
Time frame: 0-24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Even Lillejordet, MD contact
Siri Lillegraven, MD, MPH, PhD principal investigator
Diakonhjemmet
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging informed treat-to-target and Conventional treat-to-target in people with Psoriatic Arthritis, run by Diakonhjemmet Hospital at 12 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siri Lillegraven, MD, MPH, PhD (+4722451500, siri.lillegraven@diakonsyk.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Remission (time frame: Sustained remission is defined by the patient meeting VLDA at all of 16, 20 and 24 month follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.