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NCT02374021 · ClinicalTrials.gov registry record · Phase 4
Treatments Against RA and Effect on FDG-PET/CT
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 159
- Enrollment target
NCT02374021: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT02374021 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 159 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02374021, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 159 participants
- Enrollment target
Study 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).
Primary Outcome
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 we
Interventions
- DRUG Adalimumab
- DRUG Methotrexate
- DRUG Hydroxychloroquine
- DRUG Sulfasalazine
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2016-07 |
| Est. Completion | 2021-05 |
| Phase | Phase 4 |
What the finished NCT02374021 record still lists
NCT02374021 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 5 interventions - of which Adalimumab is the first listed.
NCT02374021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02374021 about?
NCT02374021 is a clinical study titled "Treatments Against RA and Effect on FDG-PET/CT". 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 com...
What is the current status of trial NCT02374021?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 159 participants. The study started on 2016-07. Estimated completion is 2021-05.
What interventions are being tested in trial NCT02374021?
The interventions under investigation include: Adalimumab (DRUG), Methotrexate (DRUG), Hydroxychloroquine (DRUG), Sulfasalazine (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT02374021?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02374021's enrollment target sits among peer trials
159 516th of 2000 higher than 1,485 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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