Clinical trial NCT03449589: Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis
Official title: Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Atherosclerosis
Pain
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-02-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 20-60 years diagnosed with rheumatoid arthritis

Exclusion Criteria:

* Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible

Primary outcomes:
measure: Disease activity score (DAS 28)
timeFrame: At patient enrollment/study visit
measure: Pain sensitivity (Pressure Pain Detection Threshold, PPDT)
timeFrame: At patient enrollment/study visit
measure: Subjective pain perception (VAS)
timeFrame: At patient enrollment/study visit
measure: Cardiovascular risk
timeFrame: At patient enrollment/study visit
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept of Rheumatology and Inflammation research
Study officials:
References:
citation: Lyngfelt 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.
citation: Nadali 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.