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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome

NCT01156922

Chronic Fatigue Syndrome Myalgic Encephalomyelitis

TERMINATED PHASE2

B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome

NCT01156909

Chronic Fatigue Syndrome Myalgic Encephalomyelitis

COMPLETED PHASE2

Drug Intervention in Chronic Fatigue Syndrome

NCT00848692

Chronic Fatigue Syndrome

COMPLETED PHASE2/PHASE3

Anti-CD20 in Systemic Lupus Erythematosus

NCT00036491

Lupus Erythematosus, Systemic

COMPLETED PHASE1/PHASE2

Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE

NCT01702038

Lupus Erythematosus, Systemic

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We have published a case series of pilot patient observations with B-cell depletion in Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) (Fluge and Mella, BMC Neurol, 2009). Subsequently, we published a small randomized and double-blind phase II study using rituximab induction two infusions two weeks apart (Fluge et al, Plos One, 2011).

We have completed an open label phase II study with 29 patients using rituximab induction and maintenance treatment (six rituximab infusions over 15 months, with follow-up for three years, unpublished).

We hypothesize that a subgroup of patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) have a chronically activated immune system involving B-lymphocytes, possibly a variant of an autoimmune disease, and that patients may benefit from B-cell depletion therapy.

Three substudies will be performed:

Endothelial function: assessment of Flow-Mediated Dilation and skin microcirculation at baseline and repeated during the time interval 17-21 months.

Cardiopulmonary exercise test for two following days: assessment at baseline and repeated during the time interval 17-21 months.

Gastrointestinal function: assessment at baseline and repeated during the time interval 17-21 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rituximab

Rituximab induction (two infusions two weeks apart) and maintenance (infusions at 3, 6, 9 and 12 months)

Group Type EXPERIMENTAL

Rituximab

Intervention Type 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

Saline (with added albumin), two infusions two weeks apart, followed by infusions at 3, 6, 9 and 12 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rituxan Mabthera Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME) according to Canadian diagnostic criteria (Carruthers, 2003)
* Duration of CFS/ME disease 2-15 years. For patients with mild CFS/ME duration of disease must be 5-15 years.
* Mild, Mild/Moderate, Moderate, Moderate/Severe and Severe CFS/ME may be included
* Signed informed consent

Exclusion Criteria

* Patients with fatigue, who do not comply with Canadian diagnostic criteria (2003)
* Duration of CFS/ME \< 2 years or \>15 years
* Patients with very severe CFS/ME
* Pregnancy or lactation.
* Previous malignant disease (except basal cell carcinoma in skin or uterine cervical dysplasia)
* Previous treatment with B-lymphocyte depleting therapeutic monoclonal antibodies, such as rituximab
* Previous long-term systemic immunosuppressive treatment, including drugs such as cyclosporine, azathioprine, mycophenolate mofetil, but except steroid treatment e.g. for obstructive lung disease or for other autoimmune diseases such as ulcerative colitis
* Severe endogenous depression
* Lack of ability to adhere to protocol
* Known multi-allergy with clinically assessed risk from rituximab infusion
* Reduced kidney function (serum creatinine \> 1,5x upper normal level)
* Reduced liver function (serum bilirubin or transaminases \> 1,5x upper normal level)
* Known HIV positivity, previous hepatitis B or hepatitis C
* Evidence of ongoing, active and clinically relevant infection
* Known immunodeficiency with risk from therapeutic B-cell depletion, such as hypogammaglobulinemia

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No