Rheumatoid ArthritisRAsmoNCT03449589
Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Atherosclerosis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis. Secondary aim: Evaluate cardiovascular risk in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis, Atherosclerosis, Pain
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Rheumatoid arthritis patients
Who may be able to join
- Patients aged 20-60 years diagnosed with rheumatoid arthritis
Who cannot join
- Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible
Trial locations and contacts
1 site in 1 country.
About this study
Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis.
Secondary aim: Evaluate cardiovascular risk in patients with rheumatoid arthritis.
Read the detailed description
The study will recruit patients with rheumatoid arthritis (age 20-60 years) at rheumatology clinics in Västra Götaland. All patients meeting the inclusion criteria will be informed of the study in a letter and later contacted by the study coordinator and if interested booked for a study visit at the rheumatology clinic. At the study visit the patients will meet with rheumatologist for clinical examination of their joints and tenderpoints. An algometer is used for objective quantification of the patients pain sensitivity. Questionnaire regarding medical treatment, other diseases, smoking habits, subjective pain, fatigue, anxiety and depression, ability to work and ability to perform everyday activities are filled out by the patient.
Height, weight, blood pressure, blood, urine and fat biopsy will be collected for analyse.
- Conditions
- Rheumatoid Arthritis, Atherosclerosis, Pain
- Medical subject headings
- Arthritis, Rheumatoid, Atherosclerosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | RA patients currently smoking | |
| Former smokers | RA patients who previously smoked | |
| Non smokers | Non smoking RA patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity score (DAS 28)
Difference in disease activity score (DAS 28) in smoking vs non-smoking RA-patients
Disease activity, DAS28, is calculated using a specific formula based on:
number of painful joints out of 28 joints examined number of swollen joints out of 28 joints examined erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) patient's global assessment of disease activity on a 100 mm visual analogue scale (VAS)
DAS thresholds:
DAS28 lower than 2.6: remission DAS28 below 3.2: low disease activity DAS28 over 3.2 and under 5.1: moderate disease activity DAS28 above 5.1: high disease activity
Measured: At patient enrollment/study visit
Pain sensitivity (Pressure Pain Detection Threshold, PPDT)
Difference in pain sensitivity in smoking vs non-smoking RA-patients. Testing of of all patients' pressure pain detection threshold (PPDT), i-e pain sensitivity is performed by trained personnel, using an algometer. The algometer is placed bilaterally on the nail of the thumb and on the second metatarsophalangeal joint (MTP2), giving a total of four measured points. A progressively increasing pressure is applied with the algometer and the patients are carefully instructed to signal as soon as the pressure sensation turns into pain (not to withstand the pain) and the algometer is removed. The amount of applied force shown in kPa in the display is reported as the PPDT. The measurements are performed twice for each point and an average value is calculated as the patients' pain sensitivity threshold/pressure pain detection threshold.
Measured: At patient enrollment/study visit
Subjective pain perception (VAS)
Difference in pain perception in smoking vs non-smoking RA-patients
Subjective pain perception is registered by self-reported estimation of pain on a visual analogue scale (VAS) of 100 mm concerning the week preceding the study.
Measured: At patient enrollment/study visit
Cardiovascular risk
Difference in cardiovascular risk (Framingham score) in smoking vs non-smoking RA-patients
The Framingham risk score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual calculated on the basis of the following:
Age Gender Total cholesterol HDL cholesterol Smoker Diabetes Systolic blood pressure Treatment for high blood pressure
Measured: At patient enrollment/study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startNov 2011
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449589
- Sponsor's protocol ID
- RÖK
- Acronym
- RAsmo
- Status last verified
- May 2022
- First submitted
- 7 Feb 2018
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erlandsson MC, Malmhall-Bah E, Chandrasekaran V, Andersson KME, Nilsson LM, Toyra Silfversward S, Pullerits R, Bokarewa MI. Insulin Sensitivity Controls Activity of Pathogenic CD4+ T Cells in Rheumatoid Arthritis. Cells. 2024 Dec 22;13(24):2124. doi: 10.3390/cells13242124.
PubMed 39768214Lyngfelt LI, Erlandsson MC, Nadali M, Hedjazifar S, Pullerits R, Andersson KM, Brembeck P, Silfversward ST, Smith U, Bokarewa MI. Impact of the Uncoupling Protein 1 on Cardiovascular Risk in Patients with Rheumatoid Arthritis. Cells. 2021 May 7;10(5):1131. doi: 10.3390/cells10051131.
PubMed 34067093Nadali M, Lyngfelt L, Erlandsson MC, Silfversward ST, Andersson KME, Bokarewa MI, Pullerits R. Low Soluble Receptor for Advanced Glycation End Products Precedes and Predicts Cardiometabolic Events in Women With Rheumatoid Arthritis. Front Med (Lausanne). 2021 Jan 28;7:594622. doi: 10.3389/fmed.2020.594622. eCollection 2020.
PubMed 33585503
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03449589
- Acronym / sponsor ID
- RAsmo / RÖK
- Conditions
- Rheumatoid Arthritis, Atherosclerosis, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Nov 2011 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis.
Secondary aim: Evaluate cardiovascular risk in patients with rheumatoid arthritis.
Detailed description
The study will recruit patients with rheumatoid arthritis (age 20-60 years) at rheumatology clinics in Västra Götaland. All patients meeting the inclusion criteria will be informed of the study in a letter and later contacted by the study coordinator and if interested booked for a study visit at the rheumatology clinic. At the study visit the patients will meet with rheumatologist for clinical examination of their joints and tenderpoints. An algometer is used for objective quantification of the patients pain sensitivity. Questionnaire regarding medical treatment, other diseases, smoking habits, subjective pain, fatigue, anxiety and depression, ability to work and ability to perform everyday activities are filled out by the patient.
Height, weight, blood pressure, blood, urine and fat biopsy will be collected for analyse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | –RA patients currently smoking |
| Former smokers | – | –RA patients who previously smoked |
| Non smokers | – | –Non smoking RA patients |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Rheumatoid arthritis patients
Key inclusion criteria (1 listed)
- Patients aged 20-60 years diagnosed with rheumatoid arthritis
Key exclusion criteria (1 listed)
- Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease activity score (DAS 28)
Time frame: At patient enrollment/study visit
Difference in disease activity score (DAS 28) in smoking vs non-smoking RA-patients Disease activity, DAS28, is calculated using a specific formula based on: number of painful joints out of 28 joints examined number of swollen joints out of 28 joints examined erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) patient's global assessment of disease activity on a 100 mm visual analogue scale (VAS) DAS thresholds: DAS28 lower than 2.6: remission DAS28 below 3.2: low disease activity DAS28 over 3.2 and under 5.1: moderate disease activity DAS28 above 5.1: high disease activity
Pain sensitivity (Pressure Pain Detection Threshold, PPDT)
Time frame: At patient enrollment/study visit
Difference in pain sensitivity in smoking vs non-smoking RA-patients. Testing of of all patients' pressure pain detection threshold (PPDT), i-e pain sensitivity is performed by trained personnel, using an algometer. The algometer is placed bilaterally on the nail of the thumb and on the second metatarsophalangeal joint (MTP2), giving a total of four measured points. A progressively increasing pressure is applied with the algometer and the patients are carefully instructed to signal as soon as the pressure sensation turns into pain (not to withstand the pain) and the algometer is removed. The amount of applied force shown in kPa in the display is reported as the PPDT. The measurements are performed twice for each point and an average value is calculated as the patients' pain sensitivity threshold/pressure pain detection threshold.
Subjective pain perception (VAS)
Time frame: At patient enrollment/study visit
Difference in pain perception in smoking vs non-smoking RA-patients Subjective pain perception is registered by self-reported estimation of pain on a visual analogue scale (VAS) of 100 mm concerning the week preceding the study.
Cardiovascular risk
Time frame: At patient enrollment/study visit
Difference in cardiovascular risk (Framingham score) in smoking vs non-smoking RA-patients The Framingham risk score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual calculated on the basis of the following: Age Gender Total cholesterol HDL cholesterol Smoker Diabetes Systolic blood pressure Treatment for high blood pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 39768214Erlandsson MC, Malmhall-Bah E, Chandrasekaran V, Andersson KME, Nilsson LM, Toyra Silfversward S, Pullerits R, Bokarewa MI. Insulin Sensitivity Controls Activity of Pathogenic CD4+ T Cells in Rheumatoid Arthritis. Cells. 2024 Dec 22;13(24):2124. doi: 10.3390/cells13242124.
- Derived from this study: PubMed 34067093Lyngfelt LI, Erlandsson MC, Nadali M, Hedjazifar S, Pullerits R, Andersson KM, Brembeck P, Silfversward ST, Smith U, Bokarewa MI. Impact of the Uncoupling Protein 1 on Cardiovascular Risk in Patients with Rheumatoid Arthritis. Cells. 2021 May 7;10(5):1131. doi: 10.3390/cells10051131.
- Derived from this study: PubMed 33585503Nadali M, Lyngfelt L, Erlandsson MC, Silfversward ST, Andersson KME, Bokarewa MI, Pullerits R. Low Soluble Receptor for Advanced Glycation End Products Precedes and Predicts Cardiometabolic Events in Women With Rheumatoid Arthritis. Front Med (Lausanne). 2021 Jan 28;7:594622. doi: 10.3389/fmed.2020.594622. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Atherosclerosis, run by Vastra Gotaland Region at 1 site in Sweden.
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 1 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: status not confirmed, as of the sponsor's last update on 4 May 2022. 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 Sweden. 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?
Results are not available in the source record.
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?
Disease activity score (DAS 28) (time frame: At patient enrollment/study visit). The study lists 4 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 NCT03449589, 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 4 May 2022.