Status:
COMPLETED
Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 art...
Detailed 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 enroll...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05215509
Start Date
January 1 2021
End Date
December 31 2023
Last Update
February 2 2024
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100