Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During Interleukin-6 vs. Tumor Necrosis Factor Antibody Therapy (RABEX)

  • STATUS
    Recruiting
  • End date
    Mar 30, 2024
  • participants needed
    80
  • sponsor
    Rigshospitalet, Denmark
Updated on 10 March 2022
tumor necrosis factor
tumour necrosis
Accepts healthy volunteers

Summary

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.

Description

80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI.

After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing).

Details
Condition Rheumatoid Arthritis
Treatment Exercise, No Exercise
Clinical Study IdentifierNCT05215509
SponsorRigshospitalet, Denmark
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

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
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