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Treatment Against RA and Effect on FDG PET-CT

University of North Carolina at Chapel Hill


Description

Examine the effect of Rheumatoid Arthritis modifying drugs on vascular inflammation. Compare the effects of vascular inflammation of achieving low disease activity or remission vs moderate-high disease activity,.


Keywords:

Arthritis, Auto Immune Diseases, Heart/Vascular, Joints


Category:

Drug or Biologic
Phase:4

Qualifications

 


Age
45 - 99 years


Gender
Any


Study Population

Subjects for this trial will be RA patients who are deemed methotrexate-inadequate responders (MTX-IRs, DAS28>3.2) by their treating rheumatologist, and who have not yet started treatment with a biologic DMARD and are currently not receiving any other DMARD than MTX. In order to enrich our trial subjects for atherosclerosis, male RA patients must be at least 45 years old, and women at least 50 years old


Investigator

Rumey Ishizawar
Clinical Assistant Professor
Medicine-UNCP A Rheumatology

For questions, contact:

Shruti Saxena Beem
julie_walker@med.unc.edu
(919) 966-0545
Visit Website

Recruitment Period End

February 28, 2020

Location

Primary Location
Clinical & Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 45 - 99 years

Participant qualification(s) •Fulfill ACR/EULAR 2010 criteria for RA. •Men ≥ 45 years and women ≥ 50 years. •MTX therapy for ≥ 8 weeks at ≥ 15mg weekly or on at least 7.5mg of methotrexate weekly for ≥8 weeks with a documented intolerance of higher MTX doses, and on a stable dose for the previous 4 weeks, including MTX and HCQ combination therapy. •DAS28 score > 3.2.

Not eligible if: •Prior use of biologic DMARD or small molecule DMARD (i.e. tofacitinib) in the past 6 months, use of Rituximab ever. •If a subject is considered to be an etanercept (Enbrel) or adalimumab (Humira) failure by their primary rheumatologist; •Non-biologic DMARDs other than MTX for two months prior to Screening. •Current use or use within the past 12 months of a high-intensity statin lipid lowering drug (atorvastatin/Lipitor 40mg or higher, rosuvastatin/Crestor 10mg or higher) or a PCSK9 inhibitor (alirocumab/Praluent, Evolocumab/Repatha, or Bococizumab). •Prior patient reported, physician diagnosed clinical CV event: myocardial infarction or heart attack, angina, stroke, uncompensated or severe heart failure (NYHA class III or IV), prior vascular procedure (coronary artery angioplasty or stenting, carotid endarterectomy, coronary artery bypass surgery). •Demyelinating disease; •Any of the following forms of arthritis that may otherwise explain the subject's RA symptoms: Psoriatic Arthritis, Reactive Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Polymyalgia Rheumatica •Any of the following other autoimmune and/or chronic inflammatory diseases: Inflammatory Bowel Disease, Crohn's disease, Cutaneous or Systemic Lupus, Systemic Vasculitis, Giant Cell Arteritis, Polymyositis, Dermatomyositis, Sarcoidosis, or Scleroderma. •Transient ischemic attack (TIA). •Revascularization for peripheral artery disease. •Cancer treated in last five years (except basal and squamous cell) or any lymphoma or melanoma.

Number of Visits

    » 6 In person visit(s)

    1 Screening, 5 clinic

    » 0 Remote visit(s)

Participation Period

6 months

Compensation

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.