Arthritis, Rheumatoid Clinical Trial
— TARGETOfficial title:
Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)
NCT number | NCT02374021 |
Other study ID # | 2014P002747 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | May 2021 |
Verified date | October 2022 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 159 |
Est. completion date | May 2021 |
Est. primary completion date | May 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Robert W. Levin, MD, PA | Clearwater | Florida |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Metroplex Clinical Research Center | Dallas | Texas |
United States | Altoona Research Center | Duncansville | Pennsylvania |
United States | Northwell Health | Great Neck | New York |
United States | University of Texas Health Science Center at Houston | Houston | Texas |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | University of Kentucky | Lexington | Kentucky |
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 | Columbia University Medical Center | New York | New York |
United States | Mount Sinai- Icahn School of Medicine | New York | New York |
United States | New York University School of Medicine | New York | New York |
United States | Desert Medical Advances | Palm Desert | California |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | IRIS Research and Development | Plantation | Florida |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Washington University Medical Center | Saint Louis | Missouri |
United States | University of California San Francisco | San Francisco | California |
United States | Seattle Rheumatology Associates | Seattle | Washington |
United States | Southwest Florida Clinical Research Center | Tampa | Florida |
United States | Baylor Scott & White Medical Center- Temple | Temple | Texas |
United States | Nazanin Firooz MD, Inc. | West Hills | California |
United States | The Center for Rheumatology and Bone Research | Wheaton | Maryland |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months | The primary outcome was the change in the mean of the maximum of the target to background ratio (TBR) in the most diseased segment (MDS) of of the index vessel as measured by FDG-PET/CT scans conducted at baseline and after 24 weeks of randomized treatment allocation (MDS meanmaxTBR). The index vessel is the vessel (either aorta, left carotid, or right carotid) with the highest meanmaxTBR at baseline. Higher values indicate greater vascular inflammation. FDG uptake measurement: PET-CT images were batch-analyzed by an investigator blinded to the patients' clinical information. FDG uptake was evaluated within the wall of the ascending aorta and bilateral carotid arteries (as maximum and mean standardized FDG uptake value [SUVmax and SUVmean, respectively]) approximately every 5 mm on axial images. Subsequently, the target-to-background ratio (TBR) was reported (ratio of the average arterial to blood axial slice SUVmax) to correct for the blood compartment contribution. |
0, 6 months | |
Secondary | Change From Baseline in the MDS of the Aorta | The outcome was the change in the mean of the maximum of the target to background ratio (TBR) in the most diseased segment (MDS) of the aorta as measured by FDG-PET/CT scans conducted at baseline and after 24 weeks of randomized treatment allocation (MDS meanmaxTBR). Higher values indicate greater vascular inflammation. FDG uptake measurement: PET-CT images were batch-analyzed by an investigator blinded to the patients' clinical information. FDG uptake was evaluated within the wall of the ascending aorta and bilateral carotid arteries (as maximum and mean standardized FDG uptake value [SUVmax and SUVmean, respectively]) approximately every 5 mm on axial images. Subsequently, the target-to-background ratio (TBR) was reported (ratio of the average arterial to blood axial slice SUVmax) to correct for the blood compartment contribution. |
0, 6 months | |
Secondary | Change From Baseline in the Average TBR of the Aorta | The outcome was the change in the target to background ratio (TBR) of the aorta as measured by FDG-PET/CT scans conducted at baseline and after 24 weeks of randomized treatment allocation (MDS meanmaxTBR). Higher values indicate greater vascular inflammation. FDG uptake measurement: PET-CT images were batch-analyzed by an investigator blinded to the patients' clinical information. FDG uptake was evaluated within the wall of the ascending aorta and bilateral carotid arteries (as maximum and mean standardized FDG uptake value [SUVmax and SUVmean, respectively]) approximately every 5 mm on axial images. Subsequently, the target-to-background ratio (TBR) was reported (ratio of the average arterial to blood axial slice SUVmax) to correct for the blood compartment contribution. |
0, 6 months | |
Secondary | Change From Baseline in the Average TBR of the Bilateral Carotids | The outcome was the change in the target to background ratio (TBR) of the average of the left and right carotids as measured by FDG-PET/CT scans conducted at baseline and after 24 weeks of randomized treatment allocation (MDS meanmaxTBR). The baseline values of the left and right carotids were averaged and then the follow-up values of the left and right carotids were averaged resulting in one value at each time point. Higher values indicate greater vascular inflammation. FDG uptake measurement: PET-CT images were batch-analyzed by an investigator blinded to the patients' clinical information. FDG uptake was evaluated within the wall of the ascending aorta and bilateral carotid arteries (as maximum and mean standardized FDG uptake value [SUVmax and SUVmean, respectively]) approximately every 5 mm on axial images. Subsequently, the target-to-background ratio (TBR) was reported (ratio of the average arterial to blood axial slice SUVmax) to correct for the blood compartment contribution. |
0, 6 months | |
Secondary | Change From Baseline in the Average TBR of the Index Vessel | The outcome was the change in the target to background ratio (TBR) in the index vessel as measured by FDG-PET/CT scans conducted at baseline and after 24 weeks of randomized treatment allocation (MDS meanmaxTBR). Higher values indicate greater vascular inflammation. FDG uptake measurement: PET-CT images were batch-analyzed by an investigator blinded to the patients' clinical information. FDG uptake was evaluated within the wall of the ascending aorta and bilateral carotid arteries (as maximum and mean standardized FDG uptake value [SUVmax and SUVmean, respectively]) approximately every 5 mm on axial images. Subsequently, the target-to-background ratio (TBR) was reported (ratio of the average arterial to blood axial slice SUVmax) to correct for the blood compartment contribution. |
0, 6 months |
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