Comorbidities and Outcomes in Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675516
• Other study ID #: P001
• Status: Completed
• Start date: March 1, 2004
• Est. completion date: January 1, 2017

Study information

• Verified date: July 2023
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13182
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with another other rheumatic disease

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• No specific intervention
Usual care

Locations

Country	Name	City	State
United Kingdom	Momentum Data Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Momentum Data

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Nikiphorou E, de Lusignan S, Mallen C, Khavandi K, Roberts J, Buckley CD, Galloway J, Raza K. Haematological abnormalities in new-onset rheumatoid arthritis and risk of common infections: a population-based study. Rheumatology (Oxford). 2020 May 1;59(5):9 — View Citation

Nikiphorou E, de Lusignan S, Mallen C, Roberts J, Khavandi K, Bedarida G, Buckley CD, Galloway J, Raza K. Prognostic value of comorbidity indices and lung diseases in early rheumatoid arthritis: a UK population-based study. Rheumatology (Oxford). 2020 Jun — View Citation

Nikiphorou E, de Lusignan S, Mallen CD, Khavandi K, Bedarida G, Buckley CD, Galloway J, Raza K. Cardiovascular risk factors and outcomes in early rheumatoid arthritis: a population-based study. Heart. 2020 Oct;106(20):1566-1572. doi: 10.1136/heartjnl-2019 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure		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).
Primary	Event Rate for a Composite of Incident Infections.	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	Event Rate for Incident Stroke		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).
Secondary	Event Rate for Incident Heart Failure		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).
Secondary	Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot		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).