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

Completed

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT01123265

Run by

University of Rochester

People needed

22

Starts

2010-06-01

Expected to finish

2014-06-01

Last updated by the study team

2015-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be >18 years old
• Subject must have >3 tender and swollen joints
• Subject must have must have a target lesion of greater than 3 cm in diameter
• Subjects who meet the the ClASsification of Psoriatic ARthritis (CASPAR) criteria for PsA
• Subjects must have a DC-STAMP pattern III or IV

You may not qualify if…

• Subjects with active inflammatory synovitis, dactylitis, enthesitis, osteoarthritis, axial disease, Subjects with a SLE, Sjogren's syndrome, scleroderma or inflammatory muscle disease
• Subjects with an active malignancy
• 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)
• Subjects who have been off DMARDs or biologics for less than 3 months
• Subjects judged ineligible at the discretion of the PI
• Subjects with a history of crystalline arthritis (gout, pseudogout)
• Subject pregnancy or breast feeding
• History of recurrent infections - AIM 3 Specific
• Demyelinating disorders - AIM 3 Specific
• Prior non-responsiveness to TNFi - AIM 3 Specific
• Subjects who have a BMI >30 - AIM 3 Specific MTX arm
• Subjects who have a history of type II diabetes - AIM 3 Specific MTX arm
• Subjects with a history of substance abuse including alcohol - AIM 3 Specific MTX arm

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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