Summary
Rituximab is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. ClinicalTrials.gov lists 5 registered trials linking Rituximab to ME/CFS: 1 is currently recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02229942, sponsored by Haukeland University Hospital). It plans or enrolled 151 participants. Registration activity spans 2008 to 2025. No published literature item is linked to Rituximab and ME/CFS in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome is tracked on the OSMF post-viral programme alongside ME/CFS, Long COVID, POTS and MCAS. Across the programme, 191 candidate agents are logged for ME/CFS, most of them preliminary; this page isolates the record for one of them.
Evidence table
| Evidence tier | B · Moderate |
|---|---|
| Evidence score | 27.0 (trials 17.0, literature 0.0, tier 10, approved bonus 0.0) |
| Registered trials | 5 total: 1 recruiting, 0 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 0 |
| Agent type | Behavioural (Behavioral / Protocol / Exercise, Other / Unclassified) |
| Development stage (any indication) | Investigational |
| Mechanism / class | Not recorded |
| Data sources | OSMF therapeutic agent database, ClinicalTrials.gov |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02229942 | B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study. Haukeland University Hospital · 2014 | completed | Phase 3 | 151 |
| NCT00848692 | Drug Intervention in Chronic Fatigue Syndrome Haukeland University Hospital · 2008 | completed | Phase 2 | 30 |
| NCT01156909 | B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome Haukeland University Hospital · 2010 | completed | Phase 2 | 29 |
| NCT06952413 | Study of the Efficacy and Safety for Rituximab in Myalgia Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) National Center of Neurology and Psychiatry, Japan · 2025 | recruiting | Phase 2 | 30 |
| NCT01156922 | B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome Haukeland University Hospital · 2010 | terminated | Phase 2 | 8 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
This is a behavioural, rehabilitation or protocol-based intervention rather than a molecule, so no pharmacological mechanism is recorded.
Clinical notes: Anti-CD20 studied in ME/CFS (mixed prior). Several trials. Serious infection risk. Specialist use only for clear autoimmune subsets. 5 trial associations.
Safety: Infusion reactions, serious infections (including PML risk), hepatitis B reactivation, hypogammaglobulinemia. Requires specialist oversight, screening, monitoring.
Dosing in studies: Typical rheumatology regimens 1000 mg IV x2 (2 weeks apart) or 375 mg/m² weekly x4; ME/CFS trials used similar; repeat as needed.
Frequently asked questions
Is Rituximab approved for ME/CFS?
Rituximab is tracked by OSMF as an investigational option for ME/CFS; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Rituximab in clinical trials for ME/CFS?
ClinicalTrials.gov lists 5 registered trials linking Rituximab to ME/CFS: 1 is currently recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02229942, sponsored by Haukeland University Hospital). It plans or enrolled 151 participants. Registration activity spans 2008 to 2025.
What does the evidence show for Rituximab in ME/CFS?
Rituximab has 3 completed registered trials for ME/CFS but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is B (Moderate), taken from the OSMF therapeutic agent database, which grades agents by the volume and design of condition-specific evidence rather than by effect size.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-10-07. Page built 2026-10-07.