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

NCT01123265 | Completed

• 1 other identifier: RSRB - 32368
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriatic Arthritis

Keywords

PsA; methotrexate; Anti-TNF; TNF; DC-Stamp

Outcome Measures

Primary Outcomes (6)

• Analysis of T cell subset and dendritic cell (DC) subset for DC-STAMP expression

  Determine whether DC-STAMP+ cells belong to the Th17 subset and also analyze the DC subsets for DC-STAMP expression.

  Week 0 (Baseline)

• Analysis of T cell subset and DC subset for DC-STAMP expression

  Determine whether DC-STAMP+ cells belong to the Th17 subset and also analyze the DC subsets for DC-STAMP expression.

  Week 16

• DC-STAMP as a marker of disease severity in PsA

  Baseline measurement of DC-STAMP expression will be collected in order to assist in determining whether it is associated with more severe features of PsA. DC-STAMP expression will be correlated with clinical variables of arthritis and skin disease, CRP and x-ray damage.

  Week 0 (Baseline)

• DC-STAMP as a marker of disease severity in PsA

  Measurement of DC-STAMP expression will be collected in order to assist in determining whether it is associated with more severe features of PsA. DC-STAMP expression will be correlated with clinical variables of arthritis and skin disease, CRP and x-ray damage.

  Week 16

• DC-STAMP as a biomarker of treatment response in PsA

  A baseline measurement of DC-STAMP as a response marker to treatment will be collected. Ten subjects will receive methotrexate and ten will receive anti-TNF therapy. The correlation between DC-STAMP variables (percentage of 1A2+ divided by 1A2 - cells X 100) and the variables detailed in Aim 2 will be analyzed in these 2 treatment groups at 2 different time points.

  Week 0 (Baseline)

• DC-STAMP as a biomarker of treatment response in PsA

  A measurement of DC-STAMP as a response marker to treatment will be collected. Ten subjects received methotrexate and ten received anti-TNF therapy. The correlation between DC-STAMP variables (percentage of 1A2+ divided by 1A2 - cells X 100) and the variables detailed in Aim 2 will be analyzed in these 2 treatment groups at 2 different time points.

  Week 16

Study Arms (2)

Anti-TNF

Drug: Anti-TNF

Methotrexate

Drug: Methotrexate

Interventions

Methotrexate DRUG

Subjects will start Methotrexate which will be escalated from 7.5 mg weekly to 15 mg/weekly over a 3 week period.

Methotrexate

Anti-TNF DRUG

Anti-TNF to be administered per standard of care within the practice.

Anti-TNF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female population that are 18 years old and older.

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

Sponsors & Collaborators

• University of Rochester: lead
• National Psoriasis Foundation: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christopher Ritchlin, MD / MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H.; Professor of Medicine Allergy, Immunology & Rheumatology Division

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 14, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 21, 2015

Record last verified: 2015-09

Locations

US (1)