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

Alzheimer Disease Clinical Trial

Official title:

Comparing Rates of Dementia and Alzheimer's Disease in Patients Initiating Methotrexate Versus Those Initiating Anti-TNF-α Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571697
• Other study ID #: CR108890
• Secondary ID: PCSNSP002938
• Status: Completed
• Start date: September 28, 2020
• Est. completion date: October 27, 2020

Study information

• Verified date: October 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34647
• Est. completion date: October 27, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Drug:
• Methotrexate
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.
• Anti-TNF
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.

Locations

Country	Name	City	State
United States	Janssen R&D	Titusville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Newly Diagnosed Alzheimer's Disease (AD) Cases	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.	365 days