Helping people with rheumatoid arthritis to stop smoking - a multicentre study

A multicentre randomized controlled trial of a brief smoking cessation intervention in patients with rheumatoide arthritis compared to usual care: effects on smoking behaviour and disease activitiy (QuiSIRA - Quick Smoking Intervention in active smoking Rheumatoid Arthritis patients)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62763366

Enrollment

140

Registered

2025-10-23

Start date

2024-06-26

Completion date

Unknown

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis and nicotine consumption Musculoskeletal Diseases

Interventions

To assess whether a quick smoking intervention can support smoking cessation in patients with rheumatoid arthritis, participants will be randomly assigned to one of two groups. In the intervention gro

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of RA according to ACR/EULAR criteria, no overlap syndromes except for secondary Sjögren Syndrom allowed 2. Outpatients/ inpatients (age >18 years) from St. Elisabeth-Hospital Meerbusch-Lank and from University Hospital Düsseldorf 3. Active cigarette smoking patients (at least five conventional cigarettes per day in the last week) 4. Sufficient proficiency in German language (at least C1) as judged by the intervenor

Exclusion criteria

Exclusion criteria: 1. Occasional smokers (less than five conventional cigarettes per day in the last week) 2. Use of vaporizers only 3. Use of tabacco heaters only 4. Prior structured smoking intervention: 5. Prior structured quick smoking intervention (to the best of the patient’s knowledge) 6. Prior alternative smoking intervention treatments such as hypnosis or acupuncture 7. Nicotine replacement therapy at the moment (nicotine-containing patches, chewing gum, lozenges, sprays, inhalers) 8. Medication for smoking cessation at the moment (Bupropion, Cytisin, Vareniclin)

Design outcomes

Secondary

Measure	Time frame
1. Disease activity measured using DAS28 CRP at week 12 and week 48 2. Flare rate defined as increase or initiation of = 5 mg daily prednisone or change of medication or new medication at week 12 and week 48 3. Health-related quality of life measured by VR 12-questionnaire at week 12 and week 48 4. Antirheumatic medication at week 12 and week 48 measured by questionnaires 5. Nicotine dependence measured by Fagerström-questionnaire at week 12 and week 48 6. Number of abstinence attempts measured by questionnaires at week 12 and week 48 7. Carbon monoxide measured by Micro+Tm Smokerlyzer at week 12 and week 48 8. Lifestyle information measured by MEDAS-questionnaire and physical activity assessment at week 12 and week 48 9. Number of cigarettes smoked per day at week 12 and week 48 measured by questionnaires 10. Seeking of additional support since week 0 (e.g. hypnosis, acupuncture, smoking cessation counselling) measured by questionnaires	—

Measure

Time frame

1. Disease activity measured using DAS28 CRP at week 12 and week 48 2. Flare rate defined as increase or initiation of = 5 mg daily prednisone or change of medication or new medication at week 12 and week 48 3. Health-related quality of life measured by VR 12-questionnaire at week 12 and week 48 4. Antirheumatic medication at week 12 and week 48 measured by questionnaires 5. Nicotine dependence measured by Fagerström-questionnaire at week 12 and week 48 6. Number of abstinence attempts measured by questionnaires at week 12 and week 48 7. Carbon monoxide measured by Micro+Tm Smokerlyzer at week 12 and week 48 8. Lifestyle information measured by MEDAS-questionnaire and physical activity assessment at week 12 and week 48 9. Number of cigarettes smoked per day at week 12 and week 48 measured by questionnaires 10. Seeking of additional support since week 0 (e.g. hypnosis, acupuncture, smoking cessation counselling) measured by questionnaires

—

Primary

Measure	Time frame
Non-smoking rate at 12 (+/- 6) weeks (seven-day point prevalence abstinence) measured by questionnaires	—

Countries

Germany

Contacts

Public ContactStefan Vordenbäumen

stefan.vordenbaeumen@rrz-meerbusch.de+49 2150917187

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026