Overview

National Psoriasis Foundation - Dendritic Cell-Specific Transmembrane Protein (DC-Stamp) Biomarker Study

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
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?
No
Details
Lead Sponsor:
University of Rochester
Collaborator:
National Psoriasis Foundation
Treatments:
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