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

NCT04571697 | Completed FDA Drug

• 2 other identifiers: CR108890PCSNSP002938
• Study Type: observational
• Target: 34,647
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Newly Diagnosed Dementia Cases

  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.

  365 days

Secondary Outcomes (1)

• Newly Diagnosed Alzheimer's Disease (AD) Cases

  365 days

Study Arms (1)

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.

Drug: Methotrexate; Drug: Anti-TNF

Interventions

Methotrexate DRUG

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.

Participants Initiating Therapy with Methotrexate or Anti-TNF

Anti-TNF DRUG

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.

Participants Initiating Therapy with Methotrexate or Anti-TNF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Janssen R&D

Titusville, New Jersey, 08560, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: September 28, 2020
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2020
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)