Rituximab as therapy for autoantibody mediated fibromyalgia (RAFT) - proof of concept

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Stockholm – SLSO

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2026-02-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To investigate whether Rx treatment can reduce the average daily pain measured with VAS during week 16 after given treatment with Rx.

Secondary objectives 1

1. Investigate whether Rx treatment can improve FM symptoms and the patient's perception of their disease, as well as reduce the amount of affecting anti-FM antibodies.

Conditions and MedDRA coding

Fibromyalgia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. The study participant must have provided written informed consent.
2. Age 18–65 years
3. 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).
4. FM disease duration since diagnosis no more than 2 years, and since symptom onset no more than 5 years.
5. FM disease burden with VAS pain ≥ 50 mm (0-100mm)
6. The patient has tested positive for FM-associated antibodies (Camilla Svensson’s laboratory, Biomedicum, Karolinska Institutet) (2,3), according to current reference intervals.
7. 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.
8. 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.
9. The study participants must be able and willing to comply with all study procedures.
10. 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.

Exclusion criteria 17

1. Diagnosis of another autoimmune disease, exclusive stable, substituted hypothyreosis.
2. Ongoing or recently discontinued (within the last 6 months) immunosuppressive treatment.
3. Known immunodeficiency.
4. Neuropsychiatric diagnosis.
5. Use of opioids or benzodiazepine
6. Active malignancy within the past 5 years.
7. Ongoing or planned pregnancy or breastfeeding.
8. Severe infection within the past 3 months.
9. 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.
10. Severe heart failure (New York Heart Association Class IV) or severe uncontrolled heart disease.
11. Hypersensitivity to the active substance, murine proteins, or any other substance in the investigational medicinal product
12. Participation in any other clinical trial of an investigational drug, or exposure to any investigational product or procedure within 6 months prior to screening.
13. 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.
14. BMI > 35.
15. Vaccination less than 4 weeks prior to inclusion.
16. Previous use of rituximab for any indication.
17. Any other disease, medical condition, or planned procedure that, in the opinion of the study physician, constitutes a contraindication for participation.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome measure is mean reduction of pain in VAS (mm) 16 weeks after rituximab treatment.

Secondary endpoints 1

1. Secondary outcome measures are improvement in patient perceived FM symptoms measured by Fibromyalgia Impact Questionnaire (FIQ) and Patient Global Impression of Change (PGIC) and objective reduction of % of satellite glia cell binding human IgG, which are regarded to mediate pain at week 16.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Stockholm – SLSO

Sponsor organisation

Region Stockholm – SLSO

Address

Solnavagen 1 E, S:t Matteus S:t Matteus

City

Stockholm

Postcode

113 65

Country

Sweden

Scientific contact point

Organisation

Region Stockholm – SLSO

Contact name

Marika Kvarnström

Public contact point

Organisation

Region Stockholm – SLSO

Contact name

Marika Kvarnström

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications