Drug Intervention in Chronic Fatigue Syndrome

B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. A Double-blind, Placebo-controlled Study.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00848692

Acronym

KTS-1-2008

Enrollment

Registered

2009-02-20

Start date

2008-06-30

Completion date

2010-06-30

Last updated

2021-05-11

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

Conditions

Chronic Fatigue Syndrome

Keywords

Chronic Fatigue Syndrome, CFS, Myalgic Encephalomyelitis, Rituximab, B-lymphocyte depletion, B-cell depletion

Brief summary

Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy. The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.

Interventions

DRUGRituximab

Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart

DRUGSaline (NaCl 0,9 %) (placebo)

Two infusions of saline (NaCl 0,9 %) given two weeks apart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* verified chronic fatigue syndrome (CDC-criteria) * age \>18 and \<60 years * informed consent

Exclusion criteria

* pregnancy or lactation * previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ * previous long-term use of immunosuppressive drugs * previous exposure to rituximab * endogenous depression * multi-allergy with risk of serious drug reaction * reduced renal function (creatinin \> 1.2 x UNL) * reduced liver function (bilirubin or transaminases \> 1.5 x UNL) * known HIV infection * signs of active viral infection by pretreatment investigations

Design outcomes

Primary

Measure	Time frame
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.	3 months after intervention

Secondary

Measure	Time frame
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes	2, 4, 6, 8, 10, 12 months after intervention

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026