Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · May 6, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how fatigue and muscle issues affect people with axial spondyloarthritis (SpA), which is a type of inflammatory arthritis that affects the spine and can cause significant discomfort and fatigue. The trial aims to better understand the relationship between the tiredness that patients feel and the physical impact on their muscles. Researchers want to find out how severe fatigue affects exercise capacity and muscle strength in patients newly starting specific treatments for their condition.

To participate in this trial, you must be at least 18 years old and diagnosed with axial spondyloarthritis, and you should not have been on specific treatments for more than 15 days before joining. You’ll also need to be able to understand the study and sign a consent form. If you decide to take part, you can expect to undergo assessments that will help researchers learn more about how fatigue and muscle function relate to your condition. This study is important because it could lead to better support and treatment strategies for those living with axial spondyloarthritis.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Axial SA according to the ASAS criteria;
• • Targeted therapy naïve patients
• • Indication to start a targeted therapy;
• • Initiation of targeted therapy ≤ 15 days before inclusion
• • ≥ 18 years old, no upper age limit;
• • Subject affiliated to a social health insurance reimbursement;
• • Subject able to understand the aims and risks of the research and having signed a dated and informed consent
• • Subject informed of the results of the preliminary medical examination
• • Woman in childbearing age: negative beta-HCG test and effective contraception;
• • Sufficient understanding of French to follow the protocol.
• Exclusion criteria:
• • Targeted therapy in progress for \> 15 days prior to inclusion
• • Contraindication to the use of targeted therapy
• • Systemic corticosteroids in the 15 days preceding the V0 visit
• • Associated extramuscular inflammatory disease (s) (excluding ocular and cutaneous involvement) eg chronic inflammatory bowel disease
• • Associated fibromyalgia (Questionnaire score FiRST ≥5) achieved during the V0 visit
• • History of coronary artery disease: exercise angina, acute coronary syndrome and / or coronary angioplasty,
• • History of lower extremity arterial disease: vascular claudication and / or lower extremity angioplasty
• • COPD
• • Neuromuscular pathology
• • Insufficiency of organ (renal, hepatic pulmonary heart)
• • Sleep apnea
• • Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
• • Subject under the protection of justice
• • Subject under guardianship or curatorship
• • Breastfeeding
• • Pregnancy
• • Subject in exclusion period defined by another clinical study or participating in a study likely to impact the results of the research