Drug Intervention in Chronic Fatigue Syndrome

Sponsor
Haukeland University Hospital
Study ID
NCT00848692
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Chronic Fatigue Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
  • Saline (NaCl 0,9 %) (placebo) — DRUG
    Two infusions of saline (NaCl 0,9 %) given two weeks apart

Study Details

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.

Key Dates

Start date
Jun 30, 2008
Status verified
Jun 2011
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Rituximab
  • Placebo Comparator: 2
    Placebo (saline)

Primary Outcome Measure

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

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