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

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


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.


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).

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


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
Subjects with insulin dependent Diabetes
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note