Phase 4
Completed N=159
Treatments Against RA and Effect on FDG-PET/CT
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02374021 ↗
Enrolled (actual)
159
Serious AEs
8.8%
Results posted
Oct 2022
Primary outcomePrimary: Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months — -0.19; -0.24 ratio — p=0.79
◆ Published Evidence
Established
73citations · ~24 / year
Reducing cardiovascular risk with immunomodulators: a randomised active comparator trial among patients with rheumatoid arthritis.
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).
Linked Publications (2)
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Reducing cardiovascular risk with immunomodulators: a randomised active comparator trial among patients with rheumatoid arthritis.
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Impact of RA treatment strategies on lipids and vascular inflammation in rheumatoid arthritis: a secondary analysis of the TARGET randomized active comparator trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months |
-0.19; -0.24 | 0.79 |
| SECONDARY Change From Baseline in the MDS of the Aorta |
-0.17; -0.17 | 0.05 |
| SECONDARY Change From Baseline in the Average TBR of the Aorta |
-0.06; -0.02 | 0.05 |
| SECONDARY Change From Baseline in the Average TBR of the Bilateral Carotids |
-0.10; -0.06 | 0.05 |
| SECONDARY Change From Baseline in the Average TBR of the Index Vessel |
-0.07; -0.09 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- 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
- 2 or more high dose radiation scans in the past year (CT scan with contrast, angiogram, SPECT nuclear medicine scan, myocardial/cardiac perfusion scan)
Data sourced from ClinicalTrials.gov (NCT02374021) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.