Trial Outcomes & Findings for Comorbidities and Outcomes in Early Rheumatoid Arthritis (NCT NCT03675516)
NCT ID: NCT03675516
Last Updated: 2023-07-25
Results Overview
Recruitment status
COMPLETED
Target enrollment
13182 participants
Primary outcome 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).
Results posted on
2023-07-25
Participant Flow
Participant milestones
| Measure |
Rheumatoid Arthritis Cases
New onset cases of rheumatoid arthritis
No specific intervention: Usual care
|
Controls
Age, gender and primary care practice-matched controls
No specific intervention: Usual care
|
|---|---|---|
|
Overall Study
STARTED
|
6591
|
6591
|
|
Overall Study
COMPLETED
|
6591
|
6591
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comorbidities and Outcomes in Early Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthritis Cases
n=6591 Participants
New onset cases of rheumatoid arthritis
No specific intervention: Usual care
|
Controls
n=6591 Participants
Age, gender and primary care practice-matched controls
No specific intervention: Usual care
|
Total
n=13182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4449 Participants
n=5 Participants
|
4449 Participants
n=7 Participants
|
8898 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2142 Participants
n=5 Participants
|
2142 Participants
n=7 Participants
|
4284 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4883 Participants
n=5 Participants
|
4428 Participants
n=7 Participants
|
9311 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
255 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
429 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
128 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
253 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
36 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1263 Participants
n=5 Participants
|
1819 Participants
n=7 Participants
|
3082 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6591 participants
n=5 Participants
|
6591 participants
n=7 Participants
|
13182 participants
n=5 Participants
|
PRIMARY outcome
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).Outcome measures
| Measure |
Rheumatoid Arthritis Cases
n=6591 Participants
New onset cases of rheumatoid arthritis
No specific intervention: Usual care
|
Controls
n=6591 Participants
Age, gender and primary care practice-matched controls
No specific intervention: Usual care
|
|---|---|---|
|
Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure
|
10.62 Events per 1000 person years
Interval 9.61 to 11.69
|
8.13 Events per 1000 person years
Interval 4.26 to 9.07
|
PRIMARY outcome
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).Population: This outcome was not assessed in controls
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
Outcome measures
| Measure |
Rheumatoid Arthritis Cases
n=6591 Participants
New onset cases of rheumatoid arthritis
No specific intervention: Usual care
|
Controls
Age, gender and primary care practice-matched controls
No specific intervention: Usual care
|
|---|---|---|
|
Event Rate for a Composite of Incident Infections.
|
3506 Participants
|
0 Participants
|
SECONDARY outcome
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).Outcome measures
| Measure |
Rheumatoid Arthritis Cases
n=6591 Participants
New onset cases of rheumatoid arthritis
No specific intervention: Usual care
|
Controls
n=6591 Participants
Age, gender and primary care practice-matched controls
No specific intervention: Usual care
|
|---|---|---|
|
Event Rate for Incident Stroke
|
4.29 Events per 1000 person years
Interval 3.67 to 4.99
|
3.82 Events per 1000 person years
Interval 3.24 to 4.48
|
SECONDARY outcome
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).Outcome measures
| Measure |
Rheumatoid Arthritis Cases
n=6591 Participants
New onset cases of rheumatoid arthritis
No specific intervention: Usual care
|
Controls
n=6591 Participants
Age, gender and primary care practice-matched controls
No specific intervention: Usual care
|
|---|---|---|
|
Event Rate for Incident Heart Failure
|
3.98 Events per 1000 person years
Interval 3.39 to 4.65
|
2.72 Events per 1000 person years
Interval 2.23 to 3.29
|
SECONDARY outcome
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).Population: 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.
Outcome measures
| Measure |
Rheumatoid Arthritis Cases
n=6591 Participants
New onset cases of rheumatoid arthritis
No specific intervention: Usual care
|
Controls
Age, gender and primary care practice-matched controls
No specific intervention: Usual care
|
|---|---|---|
|
Event Rate for a Joint Operations Composite, Comprised of Incident Joint Operations on Shoulder, Elbow, Wrist, Hand, Hip, Knee, Ankle and Foot
|
20.11 Events per 1000 person years
Interval 18.63 to 21.69
|
—
|
Adverse Events
Rheumatoid Arthritis Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place