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FibromyalgiaFINENCT07346950

The Effect of Autoreactive Autoantibodies on Peripheral and Central Disease Mechanisms in Fibromyalgia.

An observational study of Fibromyalgia, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fibromyalgia
How many people
164 participants
Where
1 siteSweden
Study dates
30 Nov 2022to 18 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: In total, 80 subjects with fibromyalgia (FM) and 42 healthy controls (HC) will be included. Subjects predominantly live in Uppsala County, Sweden, which has a population of approximately 400,000 inhabitants. If we consider the prevalence of FM to be 2%, that translates to ~8,000 patients. Since the study is on female subjects, and about 70% of FM patients are female, that leaves about 5,600 patients in the pool. The sample size has been determined based on previous research where a group size of 40 subjects was deemed sizeable enough to identify meaningful differences in expression of proteins. As we are interested in two groups of FM patients, i.e., those with high and low levels of autoreactive autoantibodies, and we expect about 50% of participants with FM to have high titers, we will require about 80 participants in the FM group. For the NINS cohort, the biobank of the neurological clinic at Uppsala University Hospital will be utilized to find appropriate CSF controls.

Who may be able to join

  • Female sex
  • Age 20-70
  • Fibromyalgia according to the ACR 1990+2016 criteria for the FM cohort.

Who cannot join

  • Reported BMI > 35 during screening over a phone call.
  • Other dominant chronic pain states.
  • Autoimmune diseases (exception: primary hypothyroidism).
  • Serious somatic or psychiatric disease.
  • Current pregnancy.
  • Non-fluency in Swedish.
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

About this study

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.

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.

Conditions
Fibromyalgia
Keywords
cytokines, neuroinflammation, blood-brain barrier, BBB, fMRI, autoantibodies, skin, MRS, cerebrospinal fluid
Medical subject headings
Fibromyalgia, Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07346950
Study groupRoleWhat they receive
FMParticipants with fibromyalgia according to the ACR 1990+2016 criteria.
HCControl participants that have no pain condition. No cerebrospinal fluid was collected from this cohort.
CSF controlsA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-SGC antibodies

    Autoantibodies that bind to satellite glia cells in the dorsal root ganglia. The investigators hypothesize that autoantibody titers are associated with symptom severity (Goebel et al., 2021; Krock et al., 2023; Fanton et al., 2023), changes in inflammatory profile (af Ekenstam et al., 2025) and alterations in skin histological findings.

    Measured: At study inclusion.

Secondary outcomes (9)
  1. Neurotransmitter levels in the right thalamus

    Using magnetic resonance spectroscopy, the first 55 FM subjects and the first 25 HC subjects had their levels of neurotransmitters in the right thalamus quantified. The investigators hypothesize that FM patients will have upregulated glutamate levels in their thalamus, and that glutamate levels will be associated with restless legs symptom severity.

    Measured: At study inclusion.

  2. Inflammatory profile in serum

    Using multiplexed proximity-extension assays (OLINK, Uppsala, Sweden), the investigators aim to quantify the levels of cytokines and chemokines in the serum of patients with fibromyalgia and in healthy, pain-free controls. FM patients are hypothesized to have an upregulation of cytokines related to B-cell activity, such as CD40 (af Ekenstam et al., 2025).

    Measured: At study inclusion.

  3. Inflammatory profile in cerebrospinal fluid

    Using multiplexed proximity-extension assays, the investigators aim to quantify the levels of cytokines and chemokines in the cerebrospinal fluid of patients with fibromyalgia and in control samples from patients that underwent a neurological work-up at the neurological clinic of Uppsala University Hospital. The investigators hypothesize that fibromyalgia patients have upregulated cytokine levels in CSF (Rosenström et al., 2024a), especially regarding e.g. fractalkine, IL8, CCL19, CCL25 - which have previously been found to be upregulated (Bäckryd et al., 2017) and separately been associated with glia cell activity (Maciejewski-Lenoir et al., 1999), BBB permeability (García-Fernández et al., 2023) and fatigue (Rosenström et al., 2025).

    Measured: At study inclusion.

  4. CSF-serum albumin quotients

    The CSF/serum albumin quotient is the gold standard for quantification of blood-brain barrier integrity. The investigators hypothesize that (female) FM patients will have a more permeable BBB, i.e., higher CSF/serum albumin quotient than (female) patients with lumbar disc herniation, degenerative disc disease, osteoarthritis or control patients, suggesting an increased peripheral-central communication, which in turn has been reported to be important for the central immunoenvironment (Rosenström et al., 2025).

    Measured: At study inclusion.

  5. Quantitative sensory testing (QST)

    QST was used to measure pressure pain thresholds (PPTs), temporal summation and conditioned pain modulation in all FM and HC subjects. FM are expected to have lower PPTs, a stronger temporal summation and impaired descending inhibition compared to HC (Kosek \& Hansson, 1997).

    Measured: At study inclusion.

  6. Intraepidermal nerve fiber density (IENFD) in skin

    All FM and HC participants gave two 4mm punch biopsies of the skin from their right thigh (lateral). These samples will be used to quantify IENFD to be used as a correlation measure with autoantibody titers and inflammatory profiles in serum. The investigators expect reduced IENFD in patients with fibromyalgia (Üçeyler et al., 2013; Evdokimov et al., 2019), and hypothesize that IENFD will be correlated with autoantibody titers.

    Measured: At study inclusion.

  7. Polysomnography

    All FM and HC subjects underwent a one-night ambulatory polysomnography to characterize their sleep quality objectively. The investigators hypothesize that fibromyalgia patients have disturbed overall sleep quality (Muza et al., 2023).

    Measured: At study inclusion.

  8. Resting state functional magnetic resonance imaging (rsfMRI)

    Using rsfMRI, the resting state activity of the brain will be measured in the first 55 FM subjects and in the first 25 HC subjects. We expect a higher functional connectivity in areas related to the default network and lower functional connectivity in areas related to endogenous pain modulation (Cavicchioli et al., 2025).

    Measured: At study inclusion.

  9. Blood-brain barrier dynamics

    Using a gadolinium-enhanced, T1-weighted MRI method, the investigators will assess the dynamic permeability of the BBB in the brain of the first 55 FM subjects and the first 25 HC subjects. The investigators hypothesize that FM patients will have a more leaky BBB than controls, as indicated by a faster uptake of gadolinium in the CSF and brain parenchyme. This will be quantified by MRI physicists using standard quantification metrics that mirror physiological function.

    Measured: At study inclusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start30 Nov 2022
  3. Primary completion11 Jun 2025
  4. Study completion18 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07346950
Sponsor's protocol ID
2022-03464-01
Acronym
FINE
Status last verified
Jan 2026
First submitted
3 Dec 2025
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-SGC antibodies (time frame: At study inclusion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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