The Effect of Autoreactive Autoantibodies on Peripheral and Central Disease Mechanisms in Fibromyalgia.
Key facts
- Who runs it
- Uppsala University
- Where
- Sweden1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 164 people enrolled
- Started
- 30 Nov 2022
- Ended
- 18 Dec 2025
- Type of study
- Observational, 3 groups
- Record updated
- 16 January 2026
Who can take part
- Age
- 20 years to 70 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Female sex
- Age 20-70
- Fibromyalgia according to the ACR 1990+2016 criteria for the FM cohort
Who cannot take part
- For HC: history of chronic pain or current pain exceeding 20 on a 0-100 scale or having received an FM diagnosis
- For NINS: having received an FM diagnosis
- Autoimmune diseases (exception: primary hypothyroidism)
- Serious somatic or psychiatric disease
- Reported BMI > 35 during screening over a phone call
- Other dominant chronic pain states
- Current pregnancy
- Non-fluency in Swedish
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This observational study aims to compare disease burden and pain characteristics between fibromyalgia patients with high levels of autoreactive autoantibodies, fibromyalgia patients with low levels of autoreactive autoantibodies, and healthy controls. The primary hypothesis is that patients experience more symptoms (as measured with questionnaires) depending on their antibody titer, and that high levels of autoantibodies correlate with other biological markers, such as inflammatory profile in serum, and density of intraepidermal nerve fibers in skin.
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The secondary aim of this study is to characterize central markers of disease, which will be done using a number of methods: the investigators will quantify immune profile in the cerebrospinal fluid, measure thalamic neurotransmitter levels with magnetic resonance spectroscopy (MRS), blood-brain barrier permeability with both biochemical markers and T1-weighed gadolinium-enhanced magnetic resonance imaging (MRI), and resting state activity of the brain (MRI). The investigators hypothesize that there are signs of upregulation of the immune system of the central compartment, and that this will be correlated with altered neurotransmitter levels and an altered resting state activity.
The 3 groups in the trial
- FM
Participants with fibromyalgia according to the ACR 1990+2016 criteria.
- HC
Control participants that have no pain condition. No cerebrospinal fluid was collected from this cohort.
- CSF controls
A cohort consisting of 1) healthy controls (n = 11) recruited in another study and 2) patients with non-inflammatory neurological symptoms (NINS, n = 32) that underwent clinical workup at the neurological clinic at Uppsala University Hospital.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 16 January 2026