Clinical trial NCT03675516: Comorbidities and Outcomes in Early Rheumatoid Arthritis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 13182
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed rheumatoid arthritis identified from their primary care records.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with another other rheumatic disease

Primary outcomes:
measure: Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure
timeFrame: 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).
measure: Event Rate for a Composite of Incident Infections.
timeFrame: 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 outcomes:
measure: Event Rate for Incident Stroke
timeFrame: 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).
measure: Event Rate for Incident Heart Failure
timeFrame: 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).
measure: Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot
timeFrame: 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).
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data
name: Andy McGovern, BSc
role: STUDY_DIRECTOR
References:
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-2019-316193. Epub 2020 Mar 24.
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 1;59(6):1296-1305. doi: 10.1093/rheumatology/kez409.
citation: 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):997-1005. doi: 10.1093/rheumatology/kez344.