Rheumatoid ArthritisNCT03675516
Comorbidities and Outcomes in Early Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Momentum Data at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- No specific intervention
- How many people
- 13,182 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2004to 1 Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed rheumatoid arthritis identified from their primary care records.
Who may be able to join
- Diagnosis of rheumatoid arthritis prior to 1st January 2017
- Aged ≥18 years old
Who cannot join
- Patients with another other rheumatic disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- No specific intervention
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific interventionOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis cases | New onset cases of rheumatoid arthritis Receives: Other: No specific intervention | |
| Controls | Age, gender and primary care practice-matched controls Receives: Other: No specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure
Measured: 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
Measured: 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 (3)
Event Rate for Incident Stroke
Measured: 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
Measured: 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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Mar 2004
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andy McGovern, BSc, Study director, Momentum Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675516
- Sponsor's protocol ID
- P001
- Status last verified
- Jul 2023
- First submitted
- 14 Sep 2018
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32209618Nikiphorou 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.
PubMed 31580449Nikiphorou 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.
PubMed 31501866
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03675516
- Acronym / sponsor ID
- P001
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,182 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2004 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Posted 15 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis cases | – | Other: No specific interventionNew onset cases of rheumatoid arthritis |
| Controls | – | Other: No specific interventionAge, gender and primary care practice-matched controls |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed rheumatoid arthritis identified from their primary care records.
Key inclusion criteria (2 listed)
- Diagnosis of rheumatoid arthritis prior to 1st January 2017
- Aged ≥18 years old
Key exclusion criteria (1 listed)
- Patients with another other rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No specific interventionUsual care | Other | Controls, Rheumatoid arthritis cases |
Primary outcome
Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure
Time frame: 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.
Time frame: 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
3 secondary outcomes
Event Rate for Incident Stroke
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32209618Nikiphorou 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.
- Results publication: PubMed 31580449Nikiphorou 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.
- Results publication: PubMed 31501866Nikiphorou 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy McGovern, BSc study director
Momentum Data
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Momentum Data at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Rate for a Cardiovascular Composite of Incident Myocardial Infarction, Stroke, or Heart Failure (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03675516, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.