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Rituximab as therapy for autoantibody mediated fibromyalgia (RAFT) - proof of concept
EU CTIS ID: 2025-523465-21-00
What this study is testing
To investigate whether Rx treatment can reduce the average daily pain measured with VAS during week 16 after given treatment with Rx.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The study participant must have provided written informed consent.
- The study participants must have been vaccinated with at least three doses of a COVID-19 vaccine or have measurable titers of anti-COVID-19 antibodies.
- Age 18–65 years
- Patients with a diagnosis of fibromyalgia (FM) who meet the diagnostic criteria for FM and have been diagnosed by a treating pain specialist or rheumatologist trained in the use of these criteria (AAPT core diagnostic criteria 1990 and revised criteria from 2016).
- FM disease duration since diagnosis no more than 2 years, and since symptom onset no more than 5 years.
- FM disease burden with VAS pain ≥ 50 mm (0-100mm)
You likely can't join if
- Diagnosis of another autoimmune disease, exclusive stable, substituted hypothyreosis.
- Severe heart failure (New York Heart Association Class IV) or severe uncontrolled heart disease.
- Hypersensitivity to the active substance, murine proteins, or any other substance in the investigational medicinal product
- Participation in any other clinical trial of an investigational drug, or exposure to any investigational product or procedure within 6 months prior to screening.
- Any medical condition that, in the judgment of the study physician, may interfere with the patient’s participation in the study, pose additional risk to the patient, or complicate the assessment of the patient.
- BMI > 35.
See the full eligibility criteria
Who can join
- The study participant must have provided written informed consent.
- The study participants must have been vaccinated with at least three doses of a COVID-19 vaccine or have measurable titers of anti-COVID-19 antibodies.
- Age 18–65 years
- Patients with a diagnosis of fibromyalgia (FM) who meet the diagnostic criteria for FM and have been diagnosed by a treating pain specialist or rheumatologist trained in the use of these criteria (AAPT core diagnostic criteria 1990 and revised criteria from 2016).
- FM disease duration since diagnosis no more than 2 years, and since symptom onset no more than 5 years.
- FM disease burden with VAS pain ≥ 50 mm (0-100mm)
- The patient has tested positive for FM-associated antibodies (Camilla Svensson’s laboratory, Biomedicum, Karolinska Institutet) (2,3), according to current reference intervals.
- Pain treatment must have been stable without any change in medication or dosage during the 6 weeks prior to screening. For permitted substances, please see section 7.9.
- Women of childbearing potential must have a negative pregnancy test and use effective contraceptive methods throughout the entire study participation period, from baseline and for one year thereafter.
- The study participants must be able and willing to comply with all study procedures.
What rules you out
- Diagnosis of another autoimmune disease, exclusive stable, substituted hypothyreosis.
- Severe heart failure (New York Heart Association Class IV) or severe uncontrolled heart disease.
- Hypersensitivity to the active substance, murine proteins, or any other substance in the investigational medicinal product
- Participation in any other clinical trial of an investigational drug, or exposure to any investigational product or procedure within 6 months prior to screening.
- Any medical condition that, in the judgment of the study physician, may interfere with the patient’s participation in the study, pose additional risk to the patient, or complicate the assessment of the patient.
- BMI > 35.
- Vaccination less than 4 weeks prior to inclusion.
- Previous use of rituximab for any indication.
- Any other disease, medical condition, or planned procedure that, in the opinion of the study physician, constitutes a contraindication for participation.
- Ongoing or recently discontinued (within the last 6 months) immunosuppressive treatment.
- Known immunodeficiency.
- Neuropsychiatric diagnosis.
- Use of opioids or benzodiazepine
- Active malignancy within the past 5 years.
- Ongoing or planned pregnancy or breastfeeding.
- Severe infection within the past 3 months.
- Any ongoing acute or chronic systemic infection, including HIV, latent tuberculosis, hepatitis B or C, or any other infection considered clinically significant by the study physician and not treated with appropriate antimicrobial therapy.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.