Actively Recruiting
Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
Led by University Hospital, Strasbourg, France · Updated on 2026-03-12
122
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Axial spondyloarthropathy (SpA) is the most common inflammatory rheumatism (1% of the general population) with important medico-economic consequences. Fatigue is a major feature of SA. It can be defined as a feeling of reduced muscle capacity, lack of energy and exhaustion. The fatigue reaches an abnormally high level (fatigue severity score (FSS) ≥4, called severe fatigue in this protocol) in more than two thirds of patients with SA. Skeletal muscle repercussions are present during SA. It is characterized by a decrease in exercise capacity independently of pain and ankylosis but is associated with a decrease in strength and muscle mass, the importance of which varies from one study to another. The link between fatigue (subjective sensation) and the skeletal muscular impact (objective) of SA has never been studied.
CONDITIONS
Official Title
Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of axial spondyloarthritis according to ASAS criteria
- Patients who have not yet started targeted therapy
- Indication to begin targeted therapy
- Starting targeted therapy no more than 15 days before inclusion
- Age 18 years or older, no upper age limit
- Affiliated with social health insurance
- Able to understand the study aims and risks and provide informed consent
- Informed of preliminary medical exam results
- Women of childbearing potential must have a negative pregnancy test and use effective contraception
- Sufficient understanding of French to follow the protocol
You will not qualify if you...
- Using targeted therapy for more than 15 days prior to inclusion
- Contraindications to targeted therapy
- Systemic corticosteroid use within 15 days before first visit
- Associated extramuscular inflammatory diseases except ocular and skin involvement
- Fibromyalgia with FiRST questionnaire score of 5 or higher
- History of coronary artery disease or lower extremity arterial disease
- Chronic obstructive pulmonary disease (COPD)
- Neuromuscular diseases
- Organ insufficiency (kidney, liver, lung, heart)
- Sleep apnea
- Unable to provide informed consent (emergency situations or comprehension difficulties)
- Under legal protection, guardianship, or curatorship
- Breastfeeding or pregnant
- Participating in another clinical study that may affect results or within exclusion period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, France, 67000
Actively Recruiting
Research Team
A
Alain MEYER, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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