A Single Centre Prospective Cohort Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psoriatic Arthritis
- Sponsor
- Nanjing Medical University
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Madrid Sonographic Enthesitis Index (MASEI)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Psoriatic arthritis (PsA) is a complex inflammatory disease with heterogeneous clinical features, which complicates psoriasis in 30% of patients. PsA involves multiple tissues and clinical domains including skins and nails as well as arthritis, spondylitis, enthesitis, and dactylitis. Power Doppler (PD) ultrasonography (PDUS) is a sensitive non-invasive imaging technology used to assess disease activity and treatment response in PsA. This is a prospective, observational, open-label study to investigate disease activity, therapeutic response and bone destruction based on ultrasonography findings in patients with PsA.
Investigators
Rui LIU, MD
MD
The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •PsA patients as defined by CASPAR criteria
- •Patients must be able to comply with the visit schedule, treatment plan, laboratory tests and other study procedures
- •Patients must be given informed consent
Exclusion Criteria
- •History of other arthritis within the last 12 months
- •Concomitant disease with acute or chronic infectious diseases
- •Pregnancy or laction
- •Poorly tolerated with venipuncture required for blood sampling during the study
Outcomes
Primary Outcomes
Madrid Sonographic Enthesitis Index (MASEI)
Time Frame: 12 weeks
MASEI includes six entheses (the bilateral triceps, the quadriceps, both proximal and distal patellar and Achilles tendons and the proximal insertion of the plantar aponeurosis) and six elementary lesions (structure, thickening, erosion, enthesophytes, PD and bursa), with weighted punctuations that can be summed to a maximum score of 136.
DACTylitis glObal Sonographic (DACTOS)
Time Frame: 12 weeks
DACTOS score will be used for every affected digit. There are four keys in DACTOS scoring: PTI（Peritendon extensor inflammation） evaluated in B-mode and PD at MCP and PIP joints level (maximum score, 4) STOe（Soft tissue oedema） evaluated in B-mode and PD in the most severely affected area of the digit (maximum score, 6) flexor tenosynovitis evaluated in B-mode and PD in the most severely affected area of the digit (maximum score, 6) EULAR-OMERACT combined score for synovitis evaluated at the MCP, PIP and DIP joints (maximum score, 9) DACTOS score summation ranges from 0 to 25 points. A DACTOS value\<3 identified the US response.
Secondary Outcomes
- ACR20 Response(12 weeks)
- Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR)(12 weeks)
- Disease Activity Score 28-C-reactive protein (DAS28-CRP)(12 weeks)
- Disease Activity in PSoriatic Arthritis (DAPSA)(12 weeks)
- ACR50 Response(52 weeks)
- ACR70 Response(52 weeks)
- Minimal disease activity (MDA)(52 weeks)
- Bone destruction(104 weeks)