NCT03940911Recruiting
Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 6 May 2019
- Start date
- 13 Nov 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT03940911
What you commit to
- Study type: Interventional
- Planned participants: 122
- From 13 Nov 2025 to the primary completion date, Dec 2029
- 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
- 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
Other illness
- Associated extramuscular inflammatory disease (s) (excluding ocular and cutaneous involvement) eg chronic inflammatory bowel disease
- 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
- Insufficiency of organ (renal, hepatic pulmonary heart)
Other
- Associated fibromyalgia (Questionnaire score FiRST ≥5) achieved during the V0 visit
- COPD
- Neuromuscular pathology
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept 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 |
|---|---|---|---|
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.