Overview
National Psoriasis Foundation - Dendritic Cell-Specific Transmembrane Protein (DC-Stamp) Biomarker Study
Status:
Completed
Completed
Trial end date:
2014-06-01
2014-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine whether DC-STAMP, a protein on the surface of osteoclast precursors (OCPs), can be used as a biologic marker in Psoriatic Arthritis (PsA). With this marker the investigators hope to learn more about how OCPs develop as well as find out if DC-STAMP predicts PsA severity and how well treatment works in PsA.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of RochesterCollaborator:
National Psoriasis FoundationTreatments:
Methotrexate
Criteria
Inclusion Criteria:1. Subject must be >18 years old
2. Subject must have >3 tender and swollen joints
3. Subject must have must have a target lesion of greater than 3 cm in diameter
4. Subjects who meet the the ClASsification of Psoriatic ARthritis (CASPAR) criteria for
PsA
5. Subjects must have a DC-STAMP pattern III or IV
Exclusion Criteria:
1. Subjects with active inflammatory synovitis, dactylitis, enthesitis, osteoarthritis,
axial disease, Subjects with a SLE, Sjogren's syndrome, scleroderma or inflammatory
muscle disease
2. Subjects with an active malignancy
3. Subjects currently on biologic agents (anti-TNF agents, anti-T or B cells agents)
and/or disease-modifying antirheumatic drugs (DMARDs) (methotrexate, leflunomide,
hydroxychloroquine, azulfidine, cyclosporine, azathioprine)
4. Subjects who have been off DMARDs or biologics for less than 3 months
5. Subjects judged ineligible at the discretion of the PI
6. Subjects with a history of crystalline arthritis (gout, pseudogout)
7. Subject pregnancy or breast feeding
8. History of recurrent infections - AIM 3 Specific
9. Demyelinating disorders - AIM 3 Specific
10. Prior non-responsiveness to TNFi - AIM 3 Specific
11. Subjects who have a BMI >30 - AIM 3 Specific MTX arm
12. Subjects who have a history of type II diabetes - AIM 3 Specific MTX arm
13. Subjects with a history of substance abuse including alcohol - AIM 3 Specific MTX arm