Fatigue M32.1
Conditions
Interventions
Group 1: SLE (Systemic Lupus Erythematosus) patients treated with belimumab.
Group 2: SLE-patients not being treated with belimumab.
Sponsors
GlaxoSmithKline GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients aged between 18 and 75 years old, diagnosed with SLE according the ACR criteria from 2019. Moderate or severe fatigue in the FSMC questionnaire. Positive detection of anti-NR2 autoantibodies. Treatment with belimumab or another immunosuppressive drug. Informed consent by the patient.
Exclusion criteria
Exclusion criteria: No informed consent, lack of ability to consent or doubts about the ability to consent, insufficient knowledge of German, life-threatening situations, severe organ dysfunction (independent of SLE), existing pregnancy, chronic infections, a change of therapy within the last 6 weeks, diseases that can lead to fatigue (e.g. fibromyalgia, malignant diseases, presence of manifest heart involvement (pericarditis, myocarditis), anaemia, hypothyroidism or multiple sclerosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of fatigue score as measured with the FSMC (Fatigue Scale for Motor and Cognitive Functions) questionnaire by guided physical exercise. | — |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of anti-NR2 antibodies at baseline (0 weeks), after 12, 16 and 28 weeks. Development of VO2max at 0, 12, 16 and 28 weeks. Development of body composition at 0, 12, 16 and 28 weeks. Severity of fatigue (scores: FSMC, FACIT) at 0 and 12, 16 and 28 weeks. Health-related quality of life (SF-36, WAI, BDI, SLEQoL) after 0, 12, 16 and 28 weeks. Disease activity (SLEDAI, BILAG, Mainzer - Lupus - Score) after 0, 12, 16 and 28 weeks. Physical activity (BPAQ, IPAQ) Number of complications/flares after 28 weeks. | — |
Countries
Germany
Contacts
Public ContactAndreas Schwarting
Universitätsmedizin Mainz und ACURA Rheumazentrum RLP
Outcome results
None listed