- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571697
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
October 15, 2021 updated by: Janssen Research & Development, LLC
Comparing Rates of Dementia and Alzheimer's Disease in Patients Initiating Methotrexate Versus Those Initiating Anti-TNF-α Therapy
The purpose of the study is to compare the risk of dementia in participants diagnosed with rheumatoid arthritis (RA) exposed to anti-tumor necrosis factor (TNF) therapy versus those exposed to methotrexate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
34647
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Titusville, New Jersey, United States, 08560
- Janssen R&D
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study population consists of participants who are new user of Anti-TNF therapy diagnosed with dementia and alzheimer's disease.
Description
Inclusion Criteria:
- At least one claim for methotrexate or anti-TNF therapy during the study period. First medication received is the index medication, and date of first receipt is the index date
- 365 days of continuous pre-index observation immediately prior to the index date
- Participants have at least two occurrences of a diagnosis of rheumatoid arthritis within 365 days before and including the index date
- No prior use of methotrexate or an anti- tumor necrosis factor (TNF) therapy at any time prior to the index date
- Cohort follow-up persists until end of continuous observation or filling the comparator drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Participants Initiating Therapy with Methotrexate or Anti-TNF
Data will be collected for participants initiating therapy with either methotrexate or an anti-tumor necrosis factor (TNF) from united states (US) claims databases: optum de-identified clinformatics data mart database and IBM marketscan medicare supplemental database (MDCR).
Data collection period: 01-Jan-2000 through 31-Jul2019.
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No intervention or treatment will be administered as part of this study.
Data of participants with first claim for a methotrexate in the patient's history are included.
No intervention or treatment will be administered as part of this study.
Data of participants with first claim for an anti-TNF in the patient's history are included.
Anti-TNF includes infliximab, golimumab, etanercept, certolizumab, and adalimumab.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Newly Diagnosed Dementia Cases
Time Frame: 365 days
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An outcome of dementia requires at least two diagnosis codes international classification of diseases, ninth revision, clinical modification (ICD-9-CM) or international classification of diseases, tenth revision, clinical modification (ICD-10-CM) for dementia within 365 days of each other.
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365 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Newly Diagnosed Alzheimer's Disease (AD) Cases
Time Frame: 365 days
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An outcome of AD requires at least two diagnosis codes (ICD-9-CM or ICD-10-CM) for AD within 365 days of each other.
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365 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 28, 2020
Primary Completion (Actual)
October 27, 2020
Study Completion (Actual)
October 27, 2020
Study Registration Dates
First Submitted
September 25, 2020
First Submitted That Met QC Criteria
September 25, 2020
First Posted (Actual)
October 1, 2020
Study Record Updates
Last Update Posted (Actual)
October 18, 2021
Last Update Submitted That Met QC Criteria
October 15, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Dementia
- Alzheimer Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- CR108890
- PCSNSP002938 (Other Identifier: Janssen Research & Development, LLC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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