Arthritis, RheumatoidPhase 4TARGETNCT02374021
Treatments Against RA and Effect on FDG-PET/CT
A Phase 4 study testing Methotrexate, Sulfasalazine and Hydroxychloroquine in people with Arthritis, Rheumatoid, run by Brigham and Women's Hospital at 31 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Methotrexate, Sulfasalazine and Hydroxychloroquine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 31 sitesUnited States
- Study dates
- Jul 2016to May 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Robert W. Levin, MD, PA
Clearwater, Florida, 33765
Cleveland Clinic
Cleveland, Ohio, 44195
Metroplex Clinical Research Center
Dallas, Texas, 75231
Altoona Research Center
Duncansville, Pennsylvania, 16635
Northwell Health
Great Neck, New York, 11021
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky
Lexington, Kentucky, 40508
Loma Linda University Clinical Trial Center
Loma Linda, California, 92354
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Brigid Freyne, MD Inc.
Murrieta, California, 92563
New York University School of Medicine
New York, New York, 10003
Mount Sinai- Icahn School of Medicine
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Desert Medical Advances
Palm Desert, California, 92260
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
IRIS Research and Development
Plantation, Florida, 33324
Oregon Health & Science University
Portland, Oregon, 97329
University of California San Francisco
San Francisco, California, 94110
Seattle Rheumatology Associates
Seattle, Washington, 98122
Washington University Medical Center
St Louis, Missouri, 63110
Southwest Florida Clinical Research Center
Tampa, Florida, 33609
Baylor Scott & White Medical Center- Temple
Temple, Texas, 76508
Nazanin Firooz MD, Inc.
West Hills, California, 91307
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)
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).
Read the detailed 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Methotrexate, Sulfasalazine, Hydroxychloroquine, Etanercept, Adalimumab
- Keywords
- rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Rheumatrex
Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.
SulfasalazineDrug
Also called Azulfidine
1 gm bid
Also called Plaquenil
200 mg twice daily, not to exceed 6.5mg/kg
EtanerceptDrug
Also called enbrel
50 mg SC weekly
AdalimumabDrug
Also called Humira
40 mg SQ every other week
| Study group | Role | What they receive |
|---|---|---|
| Triple therapy (MTX+SSZ+HCQ) | Active comparator | Sulfasalazine (SSZ) 1 g bid and hydroxychloroquine (HCQ) 200 mg twice daily, not to exceed 6.5mg/kg HCQ (in addition to concomitant methotrexate [MTX]). Receives: Drug: Methotrexate; Drug: Sulfasalazine; Drug: Hydroxychloroquine |
| TNF inhibitor (etanercept or adalimumab) | Active comparator | etanercept 50 mg subcutaneously weekly or adalimumab 40 mg subcutaneously every other week (in addition to concomitant methotrexate, plus hydroxychloroquine, for subjects who were taking this at screening). Biologic treatment will be assigned randomly. Receives: Drug: Methotrexate; Drug: Etanercept; Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6 months
Secondary outcomes (4)
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.
Measured: 0, 6 months
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.
Measured: 0, 6 months
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.
Measured: 0, 6 months
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.
Measured: 0, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJul 2016
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Daniel H. Solomon, M.D.,MPH, Brigham and Women's Hospital
- Investigators
- Daniel Solomon, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374021
- Sponsor's protocol ID
- 2014P002747
- Acronym
- TARGET
- Status last verified
- Oct 2022
- First submitted
- 11 Feb 2015
- Last updated
- 26 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Liao KP, Rist P, Giles J, Santacroce L, Connelly MA, Glynn RJ, Ridker P, Tawakol A, Bathon J, Solomon DH. Impact of RA treatment strategies on lipids and vascular inflammation in rheumatoid arthritis: a secondary analysis of the TARGET randomized active comparator trial. Arthritis Res Ther. 2024 Jun 24;26(1):123. doi: 10.1186/s13075-024-03352-3.
PubMed 38915065Solomon DH, Giles JT, Liao KP, Ridker PM, Rist PM, Glynn RJ, Broderick R, Lu F, Murray MT, Vanni K, Santacroce LM, Abohashem S, Robson PM, Fayad Z, Mani V, Tawakol A, Bathon J; TARGET Trial Consortium. Reducing cardiovascular risk with immunomodulators: a randomised active comparator trial among patients with rheumatoid arthritis. Ann Rheum Dis. 2023 Mar;82(3):324-330. doi: 10.1136/ard-2022-223302. Epub 2022 Nov 30.
PubMed 36450449
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)
- ClinicalTrials.gov ID
- NCT02374021
- Acronym / sponsor ID
- TARGET / 2014P002747
- Conditions
- Arthritis, Rheumatoid
- Keywords
- rheumatoid arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Jul 2016
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Posted 26 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple therapy (MTX+SSZ+HCQ) | Active comparator | Drug: Methotrexate, Drug: Sulfasalazine, Drug: HydroxychloroquineSulfasalazine (SSZ) 1 g bid and hydroxychloroquine (HCQ) 200 mg twice daily, not to exceed 6.5mg/kg HCQ (in addition to concomitant methotrexate [MTX]). |
| TNF inhibitor (etanercept or adalimumab) | Active comparator | Drug: Methotrexate, Drug: Etanercept, Drug: Adalimumabetanercept 50 mg subcutaneously weekly or adalimumab 40 mg subcutaneously every other week (in addition to concomitant methotrexate, plus hydroxychloroquine, for subjects who were taking this at screening). Biologic treatment will be assigned randomly. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: RheumatrexSubjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route. | Drug | TNF inhibitor (etanercept or adalimumab), Triple therapy (MTX+SSZ+HCQ) |
| SulfasalazineAlso: Azulfidine1 gm bid | Drug | Triple therapy (MTX+SSZ+HCQ) |
| HydroxychloroquineAlso: Plaquenil200 mg twice daily, not to exceed 6.5mg/kg | Drug | Triple therapy (MTX+SSZ+HCQ) |
| EtanerceptAlso: enbrel50 mg SC weekly | Drug | TNF inhibitor (etanercept or adalimumab) |
| AdalimumabAlso: Humira40 mg SQ every other week | Drug | TNF inhibitor (etanercept or adalimumab) |
Primary outcome
Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months
Time frame: 0, 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.
4 secondary outcomes
Change From Baseline in the MDS of the Aorta
Time frame: 0, 6 months
Change From Baseline in the Average TBR of the Aorta
Time frame: 0, 6 months
Change From Baseline in the Average TBR of the Bilateral Carotids
Time frame: 0, 6 months
Change From Baseline in the Average TBR of the Index Vessel
Time frame: 0, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38915065Liao KP, Rist P, Giles J, Santacroce L, Connelly MA, Glynn RJ, Ridker P, Tawakol A, Bathon J, Solomon DH. Impact of RA treatment strategies on lipids and vascular inflammation in rheumatoid arthritis: a secondary analysis of the TARGET randomized active comparator trial. Arthritis Res Ther. 2024 Jun 24;26(1):123. doi: 10.1186/s13075-024-03352-3.
- Derived from this study: PubMed 36450449Solomon DH, Giles JT, Liao KP, Ridker PM, Rist PM, Glynn RJ, Broderick R, Lu F, Murray MT, Vanni K, Santacroce LM, Abohashem S, Robson PM, Fayad Z, Mani V, Tawakol A, Bathon J; TARGET Trial Consortium. Reducing cardiovascular risk with immunomodulators: a randomised active comparator trial among patients with rheumatoid arthritis. Ann Rheum Dis. 2023 Mar;82(3):324-330. doi: 10.1136/ard-2022-223302. Epub 2022 Nov 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Solomon principal investigator
Brigham and Women's Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate, Sulfasalazine and Hydroxychloroquine in people with Arthritis, Rheumatoid, run by Brigham and Women's Hospital at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months (time frame: 0, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374021, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.