NCT05215509Completed
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.
Source: ClinicalTrials.gov · Last updated 2 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 16 Nov 2021
- Start date
- 1 Jan 2021
- Primary completion date
- 10 Aug 2023
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05215509
What you commit to
- Study type: Interventional
- Participants enrolled: 69
- From 1 Jan 2021 to the primary completion date, 10 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator
- Grade 2 hypertension (systolic BP \> 160 mmHg and/or diastolic BP \>100 mmHg) despite the use of antihypertensive drugs.
- Subjects with insulin dependent Diabetes
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.