NCT03675516

Comorbidities and Outcomes in Early Rheumatoid Arthritis

Completed Results posted Last updated 25 July 2023

What this trial tests

trial testing No specific intervention in Rheumatoid Arthritis in 13,182 participants. Completed in 1 January 2017.

Timeline

1 March 2004

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Momentum Data
Status	Completed
Study type	OBSERVATIONAL
Enrollment	13,182
Start date	1 March 2004
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• No specific intervention

Conditions studied

• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Momentum Data

Who can join

10 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure Primary · 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).

Group	Value	95% CI
Rheumatoid Arthritis Cases	10.62	9.61 – 11.69
Controls	8.13	4.26 – 9.07

Event Rate for a Composite of Incident Infections. Primary · 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

Group	Value	95% CI
Rheumatoid Arthritis Cases	3506
Controls	0

Event Rate for Incident Stroke Secondary · 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).

Group	Value	95% CI
Rheumatoid Arthritis Cases	4.29	3.67 – 4.99
Controls	3.82	3.24 – 4.48

Event Rate for Incident Heart Failure Secondary · 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).

Group	Value	95% CI
Rheumatoid Arthritis Cases	3.98	3.39 – 4.65
Controls	2.72	2.23 – 3.29

Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot Secondary · 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).

Group	Value	95% CI
Rheumatoid Arthritis Cases	20.11	18.63 – 21.69

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.