Trial · NCT02374021
Treatments Against RA and Effect on FDG-PET/CT
NCT02374021, Phase 4, Completed, Brigham and Women's Hospital; results first posted 2022-10-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatments Against RA and Effect on FDG-PET/CT. Trials, record NCT02374021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02374021
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatments Against RA and Effect on FDG-PET/CT
- NCT number
- NCT02374021
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 159 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Methotrexate, Sulfasalazine, Hydroxychloroquine, Etanercept, Adalimumab
- First posted
- 2015-02-27
- Last updated
- 2022-10-26
- Results first posted
- 2022-10-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months | 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. |
| Secondary | Change From Baseline in the MDS of the Aorta | 0, 6 months | 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. |
| Secondary | Change From Baseline in the Average TBR of the Aorta | 0, 6 months | 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. |
| Secondary | Change From Baseline in the Average TBR of the Bilateral Carotids | 0, 6 months | 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. |
| Secondary | Change From Baseline in the Average TBR of the Index Vessel | 0, 6 months | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months | 0, 6 months | Participants with a FDG-PET/CT at baseline and six months for whom the primary outcome could be assessed | ratio | MEAN |
| SECONDARY | Change From Baseline in the MDS of the Aorta | 0, 6 months | Participants with a FDG-PET/CT at baseline and six months for whom the outcome could be assessed | Ratio | MEAN |
| SECONDARY | Change From Baseline in the Average TBR of the Aorta | 0, 6 months | Participants with a FDG-PET/CT at baseline and six months for whom the outcome could be assessed | Ratio | MEAN |
| SECONDARY | Change From Baseline in the Average TBR of the Bilateral Carotids | 0, 6 months | Participants with a FDG-PET/CT at baseline and six months for whom the outcome could be assessed | Ratio | MEAN |
| SECONDARY | Change From Baseline in the Average TBR of the Index Vessel | 0, 6 months | Participants with a FDG-PET/CT at baseline and six months for whom the outcome could be assessed | Ratio | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months | Triple Therapy (MTX+SSZ+HCQ) | -0.19 | Standard Deviation 0.51 | ratio | |
| Change From Baseline in Vascular Inflammation as Measured by FDG-PET/CT at 6 Months | TNF Inhibitor (Etanercept or Adalimumab) | -0.24 | Standard Deviation 0.51 | ratio | |
| Change From Baseline in the MDS of the Aorta | Triple Therapy (MTX+SSZ+HCQ) | -0.17 | Standard Deviation 0.39 | Ratio | |
| Change From Baseline in the MDS of the Aorta | TNF Inhibitor (Etanercept or Adalimumab) | -0.17 | Standard Deviation 0.52 | Ratio | |
| Change From Baseline in the Average TBR of the Aorta | Triple Therapy (MTX+SSZ+HCQ) | -0.06 | Standard Deviation 0.34 | Ratio | |
| Change From Baseline in the Average TBR of the Aorta | TNF Inhibitor (Etanercept or Adalimumab) | -0.02 | Standard Deviation 0.43 | Ratio | |
| Change From Baseline in the Average TBR of the Bilateral Carotids | Triple Therapy (MTX+SSZ+HCQ) | -0.10 | Standard Deviation 0.51 | Ratio | |
| Change From Baseline in the Average TBR of the Bilateral Carotids | TNF Inhibitor (Etanercept or Adalimumab) | -0.06 | Standard Deviation 0.48 | Ratio | |
| Change From Baseline in the Average TBR of the Index Vessel | Triple Therapy (MTX+SSZ+HCQ) | -0.07 | Standard Deviation 0.47 | Ratio | |
| Change From Baseline in the Average TBR of the Index Vessel | TNF Inhibitor (Etanercept or Adalimumab) | -0.09 | Standard Deviation 0.43 | Ratio |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Triple Therapy (MTX+SSZ+HCQ) | 80 | |
| Overall Study | STARTED | TNF Inhibitor (Etanercept or Adalimumab) | 79 | |
| Overall Study | COMPLETED | Triple Therapy (MTX+SSZ+HCQ) | 57 | |
| Overall Study | COMPLETED | TNF Inhibitor (Etanercept or Adalimumab) | 58 | |
| Overall Study | NOT COMPLETED | Triple Therapy (MTX+SSZ+HCQ) | 23 | |
| Overall Study | NOT COMPLETED | TNF Inhibitor (Etanercept or Adalimumab) | 21 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Renal Calculi | Renal and urinary disorders | Triple Therapy (MTX+SSZ+HCQ) | 0 | 80 | 0 |
| serious | Renal Calculi | Renal and urinary disorders | TNF Inhibitor (Etanercept or Adalimumab) | 2 | 79 | 2 |
| serious | Dysphagia | Gastrointestinal disorders | Triple Therapy (MTX+SSZ+HCQ) | 0 | 80 | 0 |
| serious | Dysphagia | Gastrointestinal disorders | TNF Inhibitor (Etanercept or Adalimumab) | 1 | 79 | 1 |
| serious | Myalgia | Musculoskeletal and connective tissue disorders | Triple Therapy (MTX+SSZ+HCQ) | 0 | 80 | 0 |
| serious | Myalgia | Musculoskeletal and connective tissue disorders | TNF Inhibitor (Etanercept or Adalimumab) | 1 | 79 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | Triple Therapy (MTX+SSZ+HCQ) | 0 | 80 | 0 |
| serious | Myocardial Infarction | Cardiac disorders | TNF Inhibitor (Etanercept or Adalimumab) | 1 | 79 | 1 |
| serious | Vomiting | Gastrointestinal disorders | Triple Therapy (MTX+SSZ+HCQ) | 1 | 80 | 1 |
| serious | Vomiting | Gastrointestinal disorders | TNF Inhibitor (Etanercept or Adalimumab) | 0 | 79 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triple Therapy (MTX+SSZ+HCQ) | 0 | 80 |
| Total, all-cause mortality | TNF Inhibitor (Etanercept or Adalimumab) | 0 | 79 |
| Total, other adverse events | Triple Therapy (MTX+SSZ+HCQ) | 0 | 80 |
| Total, other adverse events | TNF Inhibitor (Etanercept or Adalimumab) | 0 | 79 |
| Total, serious adverse events | Triple Therapy (MTX+SSZ+HCQ) | 4 | 80 |
| Total, serious adverse events | TNF Inhibitor (Etanercept or Adalimumab) | 10 | 79 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Triple Therapy (MTX+SSZ+HCQ) vs TNF Inhibitor (Etanercept or Adalimumab): deaths from any cause | Trial comparisons |
| Triple Therapy (MTX+SSZ+HCQ) vs TNF Inhibitor (Etanercept or Adalimumab): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02374021
GET https://conductscience.org/api/trials/v1/NCT02374021/events?page=2