Comorbidities and Outcomes in Early Rheumatoid Arthritis

July 11, 2023 updated by: Momentum Data

The Epidemiology of Cardiovascular Disease, Haematological Abnormalities, and Other Comorbidities in Early Rheumatoid Arthritis in the United Kingdom and Their Associations With Important Outcomes

Identify the burden of comorbidity at the time of diagnosis of rheumatoid arthritis. Identify the impact of comorbidity present at diagnosis on cardiovascular disease, death, rheumatoid arthritis disease progression and infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13182

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

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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed rheumatoid arthritis identified from their primary care records.

Description

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis prior to 1st January 2017
  • Aged ≥18 years old

Exclusion Criteria:

  • Patients with another other rheumatic disease

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid arthritis cases
New onset cases of rheumatoid arthritis
Other: No specific intervention
Usual care
Controls
Age, gender and primary care practice-matched controls
Other: No specific intervention
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure
Time Frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of myocardial infarction, stroke, or heart failure (whichever came first) or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of myocardial infarction, stroke, or heart failure (whichever came first) or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
Event Rate for a Composite of Incident Infections.
Time Frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of infection or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
The composite will comprise incident upper respiratory tract infections, bronchitis, influenza-like illnesses, pneumonia, intestinal infectious diseases, herpes simplex, skin and soft tissue infections, urinary tract infections, and genital and perineal infections
From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of infection or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).

Secondary Outcome Measures

Outcome Measure
Time Frame
Event Rate for Incident Stroke
Time Frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of stroke or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of stroke or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
Event Rate for Incident Heart Failure
Time Frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of heart failure or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of diagnosis of heart failure or to loss to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot
Time Frame: From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of joint operation to follow-up or until 1st January 2017 (maximum follow-up: 13 years).
From the date of rheumatoid arthritis diagnosis (after 1st January 2004) to the date of joint operation to follow-up or until 1st January 2017 (maximum follow-up: 13 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Momentum Data

Investigators

  • Study Director: Andy McGovern, BSc, Momentum Data

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2004

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 14, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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