Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid arthritis cases | New onset cases of rheumatoid arthritis |
| |
| Controls | Age, gender and primary care practice-matched controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No specific intervention | Other | Usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with newly diagnosed rheumatoid arthritis identified from their primary care records.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andy McGovern, BSc | Momentum Data | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Data Ltd | London | WC1X 8QT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32209618 | Result | 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. | |
| 31580449 | Result | 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. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis Cases | New onset cases of rheumatoid arthritis No specific intervention: Usual care |
| FG001 | Controls | Age, gender and primary care practice-matched controls No specific intervention: Usual care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis Cases | New onset cases of rheumatoid arthritis No specific intervention: Usual care |
| BG001 | Controls | Age, gender and primary care practice-matched controls No specific intervention: Usual care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure | Posted | Number | 95% Confidence Interval | Events per 1000 person 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). |
|
Over the follow-up period (maximum 10 years) from diagnosis to the first of: loss to follow-up, death, deregistration from care provider, or the end of the study period (1st January 2018)
As there was no intervention (this was an observational study) data on adverse events was not applicable therefore All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rheumatoid Arthritis Cases | New onset cases of rheumatoid arthritis No specific intervention: Usual care |
Not provided
Not provided
No data was available on mortality - this outcome was therefore dropped from the analysis
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Andrew McGovern | Momentum Data | +447531221970 | andy.mcgovern@momentumdata.co.uk |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). |
| 31501866 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | This outcome was not assessed in controls | Posted | Count of Participants | Participants | 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 | Posted | Number | 95% Confidence Interval | Events per 1000 person 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). |
|
|
|
| Secondary | Event Rate for Incident Heart Failure | Posted | Number | 95% Confidence Interval | Events per 1000 person 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). |
|
|
|
| Secondary | Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot | A comparison with controls was not included for this endpoint as this end point was only relevant to people with rheumatoid arthritis (as a marker of disease severity) and was not collected for controls. | Posted | Number | 95% Confidence Interval | Events per 1000 person 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). |
|
|
|
| 0 |
| 6,591 |
| 0 |
| 6,591 |
| 0 |
| 6,591 |
| EG001 | Controls | Age, gender and primary care practice-matched controls No specific intervention: Usual care | 0 | 6,591 | 0 | 6,591 | 0 | 6,591 |
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |