B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study.

Conditions

• Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Induction with two infusions two weeks apart, rituximab 500 mg/m2 (max 1000 mg). Maintenance with rituximab infusions (500 mg fixed dose) at 3, 6, 9 and 12 months.
• Placebo — DRUG
  Saline (NaCl 0,9%) added human albumin (Flexbumin) 0,4 mg/ml, two infusions two weeks apart. Maintenance infusions after 3,6, 9 and 12 months.

Study Details

The hypothesis is that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) have a chronically activated immune system and may benefit from B-lymphocyte treatment using the monoclonal anti-CD20 antibody rituximab with induction and maintenance treatment.

Key Dates

Start date

Sep 30, 2014

Status verified

Feb 2018

Primary completion

Sep 30, 2017

Completion

Nov 30, 2017

Study Design

Enrollment

151 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  Rituximab induction (two infusions two weeks apart) and maintenance (infusions at 3, 6, 9 and 12 months)
• Placebo Comparator: Placebo
  Saline (with added albumin), two infusions two weeks apart, followed by infusions at 3, 6, 9 and 12 months.

Primary Outcome Measure

Fatigue score, selfreported. [ Time Frame: Course of Fatigue score during 24 months follow-up. ]