DC-STAMP: Regulators of Osteoclastogenesis and Response Marker in PsA

Completed

Conditions studied: Psoriatic Arthritis

In brief

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.

Key facts

Study ID

NCT03011242

Run by

University of Rochester

People needed

47

Starts

2017-01-11

Expected to finish

2021-06-30

Last updated by the study team

2021-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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