Treatments Against RA and Effect on FDG-PET/CT

  • STATUS
    Recruiting
  • End date
    Oct 3, 2022
  • participants needed
    200
  • sponsor
    Brigham and Women's Hospital
Updated on 3 June 2020
Investigator
Daniel H Solomon
Primary Contact
The Center for Rheumatology and Bone Research (8.5 mi away) Contact
+33 other location
methotrexate
adalimumab
tumor necrosis factor
etanercept
hydroxychloroquine
DMARD
tumor necrosis factor alpha
sulfasalazine
rheumatism
tumour necrosis

Summary

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).

Description

Consenting subjects will be screened for eligibility and randomized to a treatment arm. Subjects will be randomized to a treatment arm with either synthetic disease-modifying antirheumatic drugs (DMARDs) [triple therapy: sulfasalazine, methotrexate, and hydroxychloroquine] or biologic DMARDs [etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening].

Once randomized, a baseline visit will be conducted with each subject. Baseline data collection includes questionnaires, disease activity score, and the first FDG-PET/CT imaging. After the baseline at week 0, subjects will visit with their rheumatologist at weeks 6, 12, 18, and 24 for safety labs and further collection of disease activity scores and questionnaires. The second FDG-PET/CT will be performed at week 24. Blood specimens will be collected at weeks 0, 6, 18, and 24 for bioassays. Subject participation will end after the week 24 visit.

Patients and care providers will be unblinded. The FDG-PET/CT image readers will be blinded to treatment arm as well as timepoint of image acquisition.

Details
Treatment methotrexate, Etanercept, Adalimumab, hydroxychloroquine, Sulfasalazine
Clinical Study IdentifierNCT02374021
SponsorBrigham and Women's Hospital
Last Modified on3 June 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 45 yrs?
Gender: Male or Female
Do you have any of these conditions: Rheumatoid Arthritis (Pediatric) or Rheumatoid Arthritis?
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

Exclusion Criteria

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
or more high dose radiation scans in the past year (CT scan with contrast, angiogram, SPECT nuclear medicine scan, myocardial/cardiac perfusion scan)
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