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

NCT02229942 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2021-05-11

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER

  • Norwegian Department of Health and Social Affairs

    collaborator OTHER_GOV

  • The Kavli Foundation

    collaborator UNKNOWN

  • Oslo University Hospital

    collaborator OTHER

  • Trondheim University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Sykehuset Telemark

    collaborator OTHER_GOV

  • MEandYou Foundation

    collaborator UNKNOWN

  • The Norwegian ME association

    collaborator UNKNOWN

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Olav Mella, MD, PhD · Dept. of Oncology, Haukeland University Hospital, Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-09-30
Completion
2017-11-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229942 on ClinicalTrials.gov