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

PHASE3CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

September 30, 2017

Study Completion Date

November 30, 2017

Conditions
Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)
Interventions
DRUG

Rituximab

"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."

DRUG

Placebo

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.

Trial Locations (5)

N-5021

Dept. of Oncology, Haukeland University Hospital, Bergen

N-3675

Notodden Hospital, Notodden

N-0424

CFS/ME centre, Oslo University Hospital, Oslo

N-9038

Division of Rehabilitation Services, University Hospital of North Norway, Tromsø

N-7006

Dept. of Pain and Complex Disorders, St. Olavs Hospital, Trondheim

All Listed Sponsors
collaborator

The Research Council of Norway

OTHER

collaborator

Norwegian Department of Health and Social Affairs

OTHER_GOV

collaborator

The Kavli Foundation

UNKNOWN

collaborator

Oslo University Hospital

OTHER

collaborator

Trondheim University Hospital

OTHER

collaborator

University Hospital of North Norway

OTHER

collaborator

Sykehuset Telemark

OTHER_GOV

collaborator

MEandYou Foundation

UNKNOWN

collaborator

The Norwegian ME association

UNKNOWN

lead

Haukeland University Hospital

OTHER

NCT02229942 - B-lymphocyte Depletion Using Rituximab in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). A Randomized Phase-III Study. | Biotech Hunter | Biotech Hunter