Drug Intervention in Chronic Fatigue Syndrome (KTS-1-2008)

Haukeland University Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Fatigue Syndrome

Treatments: Drug: Rituximab; Drug: Saline (NaCl 0,9 %) (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT00848692

EudraCT: 2007-007973-22

18257

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Rituximab

Treatment:

Drug: Rituximab

2

Placebo Comparator group

Description:

Placebo (saline)

Treatment:

Drug: Saline (NaCl 0,9 %) (placebo)