View clinical trials related to Axial Spondyloarthritis.
Filter by:Participants maintaining stable disease activity of Ankylosing Spondylitis (AS) with standard-dose tumor necrosis factor inhibitor (TNFi) treatment will randomly split into two groups: maintaining standard-dose TNFi, versus reduced-dose TNFi. The proportion of participants not underwent flare between the two groups will be analyzed.
The primary objective of the study is to study the change in SpA disease activity, according to ASAS20 definition (Anderson et al., 2001), after 8 weeks of VNS treatment versus placebo non-specific stimulation (control group). The secondary objectives of the Clinical Investigation are to show differences in disease evolution between the active and placebo periods of 8 weeks treatment with active VNS versus placebo VNS of the following items: 1. Change in disease activity according to "ASAS40" criteria 2. Obtaining a partial remission according to the ASAS definition 3. Change in BASFI 4. Change in C-reactive protein (CRP)serum level and erythrocytes sedimentation rate (ESR), 5. Change in ASDAS_CRP and ASDAS_ESR 6. Difference in levels of circulating cytokines, IL-6, IL-23, IL-17, IL-33 and of matrix metallopeptidases (MMP3-8-9). 7. Change in quality of life : assessment according to the following indexes: SF-36, AS Quality of Life (ASQOL) 8. Change in Health Index of patient with SpA (ASAS HI) and of the Productivity at Work Index (WPI) 9. Change in fatigue (BASDAI 1st question) and global pain 10. Change in Anxiety and Depression Assessment (HAD) 11. Change in BASMI 12. Change in non-steroidal anti-inflammatory drugs (NSAID) intake score.
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.