Comorbidities and Outcomes in Early Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03675516
• Lead Sponsor: Momentum Data

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-18
• Results First Submitted: 2021-07-01
• Results First Submitted QC: 2022-01-12
• Results First Posted: 2022-03-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13182

Inclusion Criteria

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

Exclusion Criteria

• Patients with another other rheumatic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
Event Rate for a Composite of Incident 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).	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

Secondary Outcome Measures

Name	Time	Method
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).
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).
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).

Trial Locations

Locations (1)

Momentum Data Ltd; 🇬🇧 London, United Kingdom