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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523465-21-00

Enrollment

Registered

2026-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

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

Detailed description

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.

Interventions

DRUGParacetamol ABECE 500 mg filmdragerade tabletter

DRUGMedrol 16 mg tabletter

DRUGCetirizin ABECE 10 mg filmdragerade tabletter

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 13, 2026