Drug Intervention in Chronic Fatigue Syndrome

Phase 2

Completed

• Conditions: Chronic Fatigue Syndrome
• Interventions: Drug: Saline (NaCl 0,9 %) (placebo); Drug: Rituximab

• Registration Number: NCT00848692
• Lead Sponsor: Haukeland University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-06
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Saline (NaCl 0,9 %) (placebo)	Placebo (saline)
1	Rituximab	Rituximab

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Oncology and Medical Physics, Haukeland University Hospital; 🇳🇴 Bergen, Norway