DC-STAMP: Regulators of Osteoclastogenesis and Response Marker in PsA
2 other identifiers
observational
47
1 country
1
Brief Summary
The Investigators will examine if DC-STAMP can serve as an early marker of TNFi response in PsA. Identification of such a biomarker would permit rapid transition to a new agent, a major treatment advance. TNFi are the most effective therapies in PsA, however, methotrexate is frequently initiated early in the disease course based on its significantly lower cost. Unfortunately, the efficacy of MTX has not been supported in clinical trials and up to 40% of patients do not respond to TNFi therapy. Moreover, valid biomarkers to predict MTX or TNFi responses are currently unavailable. This study may also provide the first data on the comparative efficacy of MTX and TNFi using clinical, Ultrasound (US) and biomarker outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2016
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedStudy Start
First participant enrolled
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 13, 2021
August 1, 2021
4.5 years
September 20, 2016
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessing the Change of DC-STAMP as an early TNFi response biomarker.
The Investigators will analyze the change in DC-STAMP expression from baseline to 2 weeks using flow cytometry.
Baseline to 2 weeks of standard of care treatment
Secondary Outcomes (1)
Assessing the Change of Clinical Response at 16 weeks.
Baseline to 16 weeks of standard of care treatment
Study Arms (3)
Longitudinal Cohort: Psoriatic Arthritis
Individuals diagnosed with Psoriatic Arthritis starting standard of care treatment with a TNFi or non-biologic DMARD.
Assay Development: Healthy or Psoriatic Arthritis
Individuals that are healthy or with a diagnosis of Psoriatic Arthritis will be enrolled for blood draws for assay development and/or for an ultrasound for development of techniques and scoring system validation.
Cross-Sectional: Psoriatic Arthritis
Individuals diagnosed with Psoriatic Arthritis in good disease state on stable non-biologic DMARDS or on stable TNFi.
Eligibility Criteria
Male and female subjects that are 18 years old and older. Due to the demographic distribution of the disease the investigators 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:
- 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 who will be starting a TNFi or non-biologic DMARD treatment (Subjects starting non-biologic DMARDS can have their blood drawn within the first few days of starting therapy).
- Additional Blood Draw: Positive DC-STAMP signal at baseline
- Cross-Sectional: Patients on stable DMARDS or TNFi for more than 16 weeks.
- Healthy Subjects: Healthy controls should have no active systemic disorders or inflammatory conditions that would confound the results of the study.
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 Medical Center
Rochester, New York, 14642, United States
Related Links
Biospecimen
If patient consents, peripheral blood samples that remain after study assays are completed may be stored for future non-genetic research.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Ritchlin, MD/MPH
Univerisity of Rochester
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
September 20, 2016
First Posted
January 5, 2017
Study Start
January 11, 2017
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
August 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
- 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
- Investigators at other collaborating institutions may have access to leftover samples and data. Data will not include any information that is identifying.
Samples of any type collected at the University of Rochester may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.