Fatigue and muscle health in severe axial spondyloarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with axial spondyloarthritis who have severe fatigue and are naïve to targeted therapy or have started it within 15 days. Participants undergo objective skeletal muscle testing including cycloergometer aerobic exercise testing, strength and muscle mass measurements, and standardized fatigue questionnaires at baseline and during follow-up after initiating targeted therapy. Investigators will compare subjective fatigue severity with objective muscle measures to define their relationship and how both change after starting targeted therapy. The aim is to better characterize muscle involvement in axial SpA and how targeted treatments influence fatigue and exercise capacity.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, Bas-Rhin, France Recruiting

Study contacts

• Study coordinator: Alain MEYER, MD
• Email: alain.meyer1@chru-strasbourg.fr
• Phone: +33 3 88 11 67 68

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.