Clinical trial · Interventional
Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy
Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During Interleukin-6 vs. Tumor Necrosis Factor Antibody Therapy: a Randomised, Controlled Study.
NCT05215509CI-TRIAL-00073578RABEXcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rheumatoid Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
| No exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- RA patients TNFi Exercise
- description
- The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at \>85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax
- interventionNames
- Behavioral: Exercise
- type
- ACTIVE_COMPARATOR
- label
- RA patients TNFi Control
- description
- This group will be allocated to "control" and therefore no supervised exercise regimen
- interventionNames
- Behavioral: No exercise
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 and \<70 years * Informed consent * Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria. In biological treatment with either IL-6rB og TNFi over four months prior to enrollment * Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) \<=3.2 * An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology * Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included: * Vasectomized partner * Bilateral tubal occlusion * Sexual abstinence * Intrauterine device * Hormonal contraception * Females who are considered to have no childbearing potential are * Bilateral tubal ligation * Bilateral oophorectomy * Complete hysterectomy * Postmenopausal defined as 12 months with no menses without an alternative medical cause Exclusion Criteria: * Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator * Subjects who cannot undergo MRI scans (metallic implants or claustrophobia) * Corticosteroid use per os \> 10 mg/day within seven days of study enrollment * Intramuscular corticosteroid within 3 weeks of the study enrollment * Grade 2 hypertension (systolic BP \> 160 mmHg and/or diastolic BP \>100 mmHg) despite the use of antihypertensive drugs. * Pregnancy * Subjects with insulin dependent Diabetes
References
Publications (2)
- DERIVEDJonck S, Adamsen ML, Rasmussen IE, Lytzen AA, Lok M, Vonsild Lund MA, Dreyer L, Jorgensen PG, Vejlstrup N, Kober L, Christensen R, Jacobsen S, Pedersen BK, Ellingsgaard H, Hojgaard P, Berg RMG, Christensen RH. IL-6 Inhibitors and TNF Inhibitors: Impact on Exercise-induced Cardiac Adaptations in Patients With Rheumatoid Arthritis. JACC Basic Transl Sci. 2025 May;10(5):551-563. doi: 10.1016/j.jacbts.2024.11.010. Epub 2025 Feb 5. PMID 40436519
- DERIVEDJonck S, Adamsen ML, Hojgaard P, Rasmussen IE, Ellingsgaard H, Lund MAV, Jorgensen PG, Jacobsen S, Kober L, Vejlstrup N, Dreyer L, Pedersen BK, Berg RMG, Christensen RH. Effect of a 12-week high-intensity exercise intervention: a comparison of cardiac exercise adaptations during biological disease-modifying antirheumatic drug treatment (TNF inhibitors vs IL-6 signalling inhibitors) in patients with rheumatoid arthritis - study protocol for a randomised controlled trial. BMJ Open. 2023 May 11;13(5):e068600. doi: 10.1136/bmjopen-2022-068600. PMID 37169504