Rheumatoid ArthritisDREAMNCT04529902
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - TNFi vs Abatacept
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tumor Necrosis Factor Inhibitors and Abatacept
- How many people
- 63,013 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will involve a new user, parallel group, cohort study design comparing TNF inhibitors to abatacept. The patients will be required to have continuous enrollment during the baseline period of 355 days before initiation of TNF inhibitors or abatacept (cohort entry date). Follow-up for the outcome (incident dementia), begins the day after drug initiation for analyses 1, 3, and 4 and 180 days after drug initiation for analysis 2.
Who may be able to join
- 1. No prior use of tumor necrosis factor inhibitors or abatacept anytime prior to cohort entry date
- 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
Who cannot join
- 1. Prior history of dementia measured anytime prior to cohort entry date
- 2. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
- 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tumor Necrosis Factor Inhibitors vs Abatacept
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tumor Necrosis Factor Inhibitors, Abatacept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Necrosis Factor InhibitorsDrug
TNFi claim is used as the reference group.
AbataceptDrug
Abatacept claim is used as the exposure group.
| Study group | Role | What they receive |
|---|---|---|
| Tumor necrosis factor inhibitors | Reference group Receives: Drug: Tumor Necrosis Factor Inhibitors | |
| Abatacept | Exposure group Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to dementia onset
Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations.
Measured: Through study completion (a median of 253 days)
Secondary outcomes (1)
Time to Alzheimer's disease onset Time to Alzheimer's disease onset
Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.
Measured: Through study completion (a median of 253 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start17 Aug 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Rutgers University, Johns Hopkins University
- Responsible party
- Principal investigator, Rishi J. Desai, Brigham and Women's Hospital
- Investigators
- Rishi J Desai, PhD, Principal investigator, Brigham and Women's HospitalMadhav Thambisetty, MD, PhD, Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529902
- Sponsor's protocol ID
- 2019A010961-3
- Other IDs
- 75N95019C00057
- Acronym
- DREAM
- Status last verified
- Nov 2021
- First submitted
- 25 Aug 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tumor Necrosis Factor Inhibitors vs Abatacept
- ClinicalTrials.gov ID
- NCT04529902
- Acronym / sponsor ID
- DREAM / 2019A010961-3
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63,013 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Rutgers University, Johns Hopkins University
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
Detailed description
This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor necrosis factor inhibitors | – | Drug: Tumor Necrosis Factor InhibitorsReference group |
| Abatacept | – | Drug: AbataceptExposure group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve a new user, parallel group, cohort study design comparing TNF inhibitors to abatacept. The patients will be required to have continuous enrollment during the baseline period of 355 days before initiation of TNF inhibitors or abatacept (cohort entry date). Follow-up for the outcome (incident dementia), begins the day after drug initiation for analyses 1, 3, and 4 and 180 days after drug initiation for analysis 2.
Key inclusion criteria (2 listed)
- 1. No prior use of tumor necrosis factor inhibitors or abatacept anytime prior to cohort entry date
- 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
Key exclusion criteria (3 listed)
- 1. Prior history of dementia measured anytime prior to cohort entry date
- 2. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
- 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
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 |
|---|---|---|
| Tumor Necrosis Factor InhibitorsTNFi claim is used as the reference group. | Drug | Tumor necrosis factor inhibitors |
| AbataceptAbatacept claim is used as the exposure group. | Drug | Abatacept |
Primary outcome
Time to dementia onset
Time frame: Through study completion (a median of 253 days)
Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations.
1 secondary outcome
Time to Alzheimer's disease onset Time to Alzheimer's disease onset
Time frame: Through study completion (a median of 253 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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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.
Rishi J Desai, PhD principal investigator
Brigham and Women's Hospital
Madhav Thambisetty, MD, PhD principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site 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 2 inclusion and 3 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 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to dementia onset (time frame: Through study completion (a median of 253 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2021.