Treatments Against RA and Effect on FDG-PET/CT

Completed · Phase 4

Conditions studied: Arthritis, Rheumatoid

In brief

In a randomized controlled clinical trial, investigators will compare the effects on \[18F\]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

Key facts

Study ID

NCT02374021

Run by

Brigham and Women's Hospital

People needed

159

Starts

2016-07-01

Expected to finish

2021-05-01

Last updated by the study team

2022-10-26

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fulfill American College of Rheumatology/European League Against Rheumatism 2010 criteria for RA
• Men ≥ 45 years and women ≥ 50 years
• MTX monotherapy for ≥ 8 weeks at ≥ 15mg weekly or ≥ 7.5 mg weekly with a documented intolerance to higher doses
• No non-biologic DMARDs in preceding two months (other than MTX and HCQ)
• Disease Activity Score-28 > 3.2
• Able to sign informed consent

You may not qualify if…

• Use of biologic DMARD within the past 6 months or use of rituximab ever
• Current use of >10mg per day of prednisone
• Use of a high-intensity statin lipid lowering drug or PCSK9 inhibitor in the past 12 months
• Prior patient reported, physician diagnosed clinical cardiovascular (CV) event
• Insulin-dependent or uncontrolled diabetes mellitus (DM)
• Systemic lupus erythematosus (SLE) or other autoimmune and chronic inflammatory diseases (i.e. inflammatory bowel disease, sarcoidosis)
• Cancer treated in the last 5 years (except basal and squamous cell) or any lymphoma or melanoma
• Known pregnancy, HIV, Hepatitis B Virus, Hepatitis C Virus, active (or untreated latent) tuberculosis
• Baseline: liver, renal or blood count abnormalities, Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Known sulfa allergy, macular disease or hypersensitivity to treatments; known demyelinating disease; uncompensated Congestive Heart Failure (CHF)
• Intra-articular injection within the 4 weeks prior to baseline FDG PET/CT
• 2 or more high dose radiation scans in the past year (CT scan with contrast, angiogram, SPECT nuclear medicine scan, myocardial/cardiac perfusion scan)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Loma Linda University Clinical Trial Center — Loma Linda, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Brigid Freyne, MD Inc. — Murrieta, California, United States
• Desert Medical Advances — Palm Desert, California, United States
• University of California San Francisco — San Francisco, California, United States
• Nazanin Firooz MD, Inc. — West Hills, California, United States
• Robert W. Levin, MD, PA — Clearwater, Florida, United States
• IRIS Research and Development — Plantation, Florida, United States
• Southwest Florida Clinical Research Center — Tampa, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University Medical Center — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Northwell Health — Great Neck, New York, United States
• New York University School of Medicine — New York, New York, United States
• Mount Sinai- Icahn School of Medicine — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Altoona Research Center — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.