NCT02413749

Brief Summary

Biologics such as anti-Tumor Necrosis Factor or TNF inhibitor (TNFi) for treatment of Psoriatic Arthritis (PsA) has greatly reduced bone damage. This collaborative study will provide insights into key mechanisms that underlie inflammatory arthritis and bone damage in psoriatic joints and will catalyze biomarker discovery, identifying early biologic responders to facilitate optimization of therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

April 13, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2016

Completed
Last Updated

August 18, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

April 7, 2015

Last Update Submit

August 15, 2017

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Examination of molecular mechanisms underlying DC-STAMP and TRAF3 mediated osteoclastogenesis

    Investigators will analyze TRAF3 and DC-STAMP expression in monocytes from PsA patients cross-sectionally by flow cytometry. Disease Activity Score 66/68 (DAS66/68), TRAF3 levels and the change in DC-STAMP+CD14+ will be observed to see if they correlate with standard of care treatment.

    week 0 to week 16

Secondary Outcomes (1)

  • Assessment of DC-STAMP and TRAF3 as biologic predictor and treatment response markers in PsA

    week 0 to week 16

Study Arms (2)

Stable PsA response to treatment

Individuals with psoriatic arthritis who are being treated standard of care with a stable DMARD or a biologic

PsA inadequate response to DMARD

Individuals with psoriatic arthritis who have had an inadequate response to a DMARD and are being treated standard of care with a biologic.

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female subjects that are 18 years old and older. Due to the demographic distribution of the disease we expect all or nearly all subjects to be caucasian, however no subjects will be excluded based on race or ethnic origin.

You may qualify if:

  • All Subjects
  • Ability to provide written informed consent.
  • Subjects can be of either gender but must be at least 18 years old.
  • Subjects with PsA should fulfill CASPAR criteria
  • Longitudinal
  • \. Patients with active PsA starting standard of care biologic treatment.
  • Additional Blood Draw
  • \. Positive DC-STAMP signal at baseline
  • Cross-Sectional 1. Patients on stable DMARDS or biologics for more than 16 weeks.

You may not qualify if:

  • \. Unable to donate blood because of poor venous access or intolerance of phlebotomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples that remain after study assays are completed may be stored for future non-genetic research.

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

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, Chief of Allergy, Immunology & Rheumatology Division

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

April 13, 2015

Primary Completion

December 28, 2016

Study Completion

December 28, 2016

Last Updated

August 18, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.

Time Frame
Once a subject signs the consent form to allow for sharing, If any samples remain after all tests are completed, the samples will be stored for future research indefinitely or until the subject cancels consent to share.
Access Criteria
Only investigators that the study team collaborates with will have access to samples. Data will not include any information that is identifying.

Locations

US(1)