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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treat-to-target | Other | Conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 and 24 months |
| Patient pain assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient global assessment of disease activity | Patient global assessment of disease activity on a 0-100 visual analogue scale, with higher scores Indicating more disease activity | 0-24 months |
| Patient pain assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siri Lillegraven, MD, MPH, PhD | Contact | +4722451500 | siri.lillegraven@diakonsyk.no | |
| Even Lillejordet, MD | Contact | even.lillejordet@diakonsyk.no |
| Name | Affiliation | Role |
|---|---|---|
| Siri Lillegraven, MD, MPH, PhD | Diakonhjemmet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology, Helse Møre og Romsdal HF | Recruiting | Ålesund | 6026 | Norway |
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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.
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|
| 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% |
|
Patient pain assessment on a 0-100 visual analogue scale, with higher scores Indicating more pain
| 12 and 24 months |
| Patient fatigue assessment | Patient fatigue assessment on a 0-100 visual analogue scale, with higher scores Indicating more fatigue | 12 and 24 months |
| 66 joint count for swollen joints | Structured 66 joint count for swollen joints | 12 and 24 months |
| 68 joint count for tender joints | Structured 68 joint count for tender joints | 12 and 24 months |
| Tender dactylitis count | Structured tender dactylitis count | 12 and 24 months |
| Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC entheseal index) | SPARCC magnetic resonance imaging entheseal index | 12 and 24 months |
| Body surface area of skin psoriasis | Body surface area of skin psoriasis in percentage | 12 and 24 months |
| Modified Nail Psoriasis Severity Index (mNAPSI) | Modified Nail Psoriasis Severity Index (mNAPSI) | 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 | 12 and 24 months |
| C-reactive protein (CRP) | C-reactive protein (CRP), higher scores indicating more inflammation | 12 and 24 months |
| Erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate (ESR), higher scores indicating more inflammation | 12 and 24 months |
| Disease activity in Psoriatic arthritis Score (DAPSA) | Disease activity in Psoriatic arthritis Score (DAPSA), higher scores indicating more disease activity | 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. | 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 | 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. | 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 | 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 | 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 | 12 and 24 months |
| Health Related Quality of Life | Assessed by Short Form 36 (SF-36) questionnaire | 12 and 24 months |
| Adverse events | Number and nature of adverse events and serious adverse events | 0-24 months |
Patient pain assessment on a 0-100 visual analogue scale, with higher scores Indicating more pain
| 0-24 months |
| Patient fatigue assessment | Patient fatigue assessment on a 0-100 visual analogue scale, with higher scores Indicating more fatigue | 0-24 months |
| Bath Ankylosing Spondylitis Disease Activity Index | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), higher scores indicating more disease activity | 0-24 months |
| Patient acceptable symptom state | Patient acceptable symptom state (PASS) | 0-24 months |
| 66 joint count for swollen joints | 66 joint count for swollen joints | 0-24 months |
| 68 joint count for tender joints | 68 joint count for tender joints | 0-24 months |
| Tender dactylitis count | Tender dactylitis count | 0-24 months |
| Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC entheseal index) | SPARCC MRI entheseal index | 0-24 months |
| Body surface area of skin psoriasis | Body surface area of skin psoriasis in percentages | 0-24 months |
| Investigator global assessment of skin psoriasis | Investigator global assessment of skin psoriasis | 0-24 months |
| Modified Nail Psoriasis Severity Index (mNAPSI) | Modified Nail Psoriasis Severity Index (mNAPSI) | 0-24 months |
| Physician global assessment of disease activity | Physician global assessment of disease activity on a 0-100 visual analogue scale | 0-24 months |
| C-reactive protein (CRP) | C-reactive protein (CRP), higher scores indicating more inflammation | 0-24 months |
| Erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate (ESR), higher scores indicating more inflammation | 0-24 months |
| Disease activity in Psoriatic arthritis Score (DAPSA) | Disease activity in Psoriatic arthritis Score (DAPSA) | 0-24 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. | 0-24 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 | 0-24 months |
| American College of Rheumatology (ACR) response | American College of Rheumatology (ACR) response | 0-24 months |
| Disease Activity score 28 (DAS-28) | Disease Activity score 28 (DAS-28) | 0-24 months |
| Inflammation assessed musculoskeletal ultrasound |
| 0 and 24 months |
| Inflammation assessed by MRI | MRI of total spine and sacroiliac joint, assessed by SPARCC score | 12 and 24 months |
| Joint damage assessed by radiography of hands and feet | Assessed by the modified Sharp van der Heijde Score | 24 months |
| Work Productivity and Activity Impairment Questionnaire (WPAI) | Work Productivity and Activity Impairment Questionnaire (WPAI) | 0-24 months |
| Work participation | Work participation based on data from Statistics Norways's event database (FD Trygd) (social benefits) | 0-24 months |
| Euro Quality of Life 5 Dimensions (EQ-5D) | Euro Quality of Life 5 Dimensions (EQ-5D) | 0-24 months |
| Short Form 36 (SF-36) | Short Form 36 (SF-36) | 0-24 months |
| Psoriatic Arthritis Impact of Disease (PsAID) | Psoriatic Arthritis Impact of Disease (PsAID) | 0-24 months |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Health Assessment Questionnaire Disability Index (HAQ-DI) | 0-24 months |
| Use of hospital services | Use of hospital services from The Norwegian Patient Register | 0-24 months |
| Medication prescription | Prescription of medication from The Norwegian Prescription Register (pharmaceuticals) | 0-24 months |
| Use of primary care resources | Use of primary care resources based on data from Norway Control and Payment of Health Reimbursement (KUHR) database (primary care services) (d) Municipal patient- and user register (IPLOS) database (nursing services) | 0-24 months |
| Use of nursing services | Use of nursing services based on the municipal patient- and user register (IPLOS) database | 0-24 months |
| Department of Rheumatology, Haukeland University Hospital, Helse Bergen HF | Recruiting | Bergen | 5021 | Norway |
|
| Department of Rheumatology, Drammen Hospital, Vestre Viken HF | Recruiting | Drammen | 3004 | Norway |
|
| Helse Førde | Recruiting | Førde | Norway |
|
| Haugesunds Sanitetsforening Revmatismesykehus | Recruiting | Haugesund | 5504 | Norway |
|
| Sørlandet Sykehus | Recruiting | Kristiansand | Norway |
|
| Revmatismesykehuset AS | Recruiting | Lillehammer | Norway |
|
| Helgelandssykehuset, Mo i Rana | Recruiting | Mo i Rana | 8613 | Norway |
|
| Department of Rheumatology, Diakonhjemmet Hospital | Recruiting | Oslo | 0319 | Norway |
|
| Martina Hansens Hospital AS | Recruiting | Sandvika | 1306 | Norway |
|
| University Hospital of Northern Norway | Recruiting | Tromsø | Norway |
|
| Department of Rheumatology, St Olavs Hospital HF | Recruiting | Trondheim | 7006 | Norway |
|
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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