Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03940911

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, France, 67000

Actively Recruiting

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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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Fatigue and Skeletal Muscle Impact in Severe Axial Spondyloarthritis | DecenTrialz