Immune Factor Rituximab on Immune Function in ME/CFS

Cort

Phoenix Rising Founder
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Arizona in winter & W. North America otherwise
NIH Study

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions

1: Experimental
Rituximab
Drug: Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart
2: Placebo Comparator
Placebo (saline)
Drug: Saline (NaCl 0,9 %) (placebo)
Two infusions of saline (NaCl 0,9 %) given two weeks apart

Eligibility

Ages Eligible for Study: 18 Years to 60 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

verified chronic fatigue syndrome (CDC-criteria)
age >18 and <60 years
informed consent

Exclusion Criteria:

pregnancy or lactation
previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
previous long-term use of immunosuppressive drugs
previous exposure to rituximab
endogenous depression
multi-allergy with risk of serious drug reaction
reduced renal function (creatinin > 1.2 x UNL)
reduced liver function (bilirubin or transaminases > 1.5 x UNL)
known HIV infection
signs of active viral infection by pretreatment investigations
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848692

Contacts

Contact: Olav Mella, MD, PdD 47 55972010 olav.mella@helse-bergen.no
Contact: ystein Fluge, MD, PhD 47 55972010 oystein.fluge@helse-bergen.no

Locations
Norway
Department of Oncology and Medical Physics, Haukeland University Hospital Recruiting
Bergen, Norway, N-5021
Contact: Olav Mella, MD, PhD 47 55972010 olav.mella@helse-bergen.no
Contact: ystein Fluge, MD, PhD 47 55972010 oystein.fluge@helse-bergen.no
Principal Investigator: Olav Mella, MD, PhD
Sub-Investigator: ystein Fluge, MD, PhD
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Olav Mella, MD, PhD Department of Oncology and Medical Physics, Haukeland University Hospital
More Information

No publications provided

Responsible Party: Department of Oncology and Medical Physics, Haukeland University Hospital ( Olav Mella, Professor, Department Director )
Study ID Numbers: 18257, EudraCT: 2007-007973-22
Study First Received: February 19, 2009
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00848692 History of Changes
Health Authority: Norway: Norwegian Medicines Agency
 

jackie

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i hope its ok to write about an adverse reaction to rituximab. if this bothers anyone i will quickly remove it (someone just tell me!)...as i'm not against this particular drug and its potential benefits..but will be extra cautious especially with pre-screening, if im offered the opportunity to use it in the future.

but id like to tell the story as i was also quite interested in this drug at one point (frankly, i still am!)..and had not talked to anyone experiencing such a severe reaction until recently....although i knew about the cautions re: PML, of course.

someone i know with severe RA (after years of standard RA drugs, the last being methotrexate) was started on rituximab. (she's 62)

she had a reaction (cant remember how much she had been given when this happened but i think it was very early in the treatment)...of anaphylactic shock, developed blood clots, was hospitalized but was able to tolerate warfarin for many months to clear the clots...but as a result she can no longer take any meds for the RA, or tolerate sedation (except a small daily dose of methylprednisolone, for some reason) including ANY pain meds for her dibilitating arthritic pain!

she is now extremely sensitive to just about everything that comes in contact with her skin - carries an epi-pen (was not prior)...and she is now in a wheelchair (because her knees are shot) and yet is allergic to all (so far) anesthesia.

we are working on getting her into UCLA in the next few weeks (transferred from the care of the VA hospital) to have her re-evaluated for drug reactions by specialists there - and hope that they can find a way for her to tolerate the type of regional anesthesia (vs general) for both knee replacement surgeries.

as a rule, i dont post "horror stories" (and most people know I'm a "fan" of experimental treatments!)...but seeing this information regarding rituximab coincided with my involvement with this patient...so thought id mention it.

naturally...an adverse or allergic reaction can happen to anyone at any time...i'd just never heard of anything this severe and possibly life-altering....and i'm sure it must be an unusual occurrance.

I dont now what the meds stats are for something like this event happening...aand i dont know how well she was pre-screened for potential problems beforehand - as her ongoing RA treatment was at the VA hospital. (she does NOT have me/cfs).

im offering this as a simple cautionary "tale" because i've witnessed it firsthand (otherwise i would not have commented).

regards...j:D
 

Dolphin

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Norwegian study

This looks like it should start recruiting soon given a Sept 2010 start date:

http://clinicaltrials.gov/ct2/show/NCT01156909?term=chronic+fatigue+syndrome&rank=4

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

This study is not yet open for participant recruitment.

Verified by Haukeland University Hospital, July 2010

First Received: July 2, 2010 No Changes Posted Sponsor: Haukeland University Hospital
Information provided by: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01156909

Purpose

Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.

The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.
Condition Intervention Phase
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis Drug: Rituximab Phase II

Study Type: Interventional
Study Design: Control: Historical Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome. An Open Label Phase II Study With Rituximab Induction and Maintenance Treatment


Resource links provided by NLM:

MedlinePlus related topics: Chronic Fatigue Syndrome Fatigue
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: Major response of at least six weeks duration, independent on when occuring, during the follow-up period. ] [ Designated as safety issue: Yes ]
The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.


Secondary Outcome Measures:
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention ] [ Designated as safety issue: Yes ]
The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion)

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Intervention Details:
Drug: Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.
Eligibility
Ages Eligible for Study: 18 Years to 66 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:
patients with CFS
age 18-66 years
informed consent

Exclusion Criteria:
patients with fatigue, not fulfilling criteria for CFS
pregnancy or lactation
previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
previous long-term use of immunosuppressive drugs, except steroids e.g. in obstructive lunge disease
endogenous depression
lack of ability to comply by the protocol
multi-allergy with risk of serious drug reaction
reduced renal function (creatinin > 1.5 x UNL)
reduced liver function (bilirubin or transaminases > 1.5 x UNL)
HIV positivity
evidence of clinically significant infection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156909

ContactsContact: Olav Mella, MD, PhD 4755972010 olav.mella@helse-bergen.no
Contact: ystein Fluge, MD, PhD 4755972010 oystein.fluge@helse-bergen.no


Locations
Norway
Dept of Oncology, Haukeland University Hospital
Bergen, Norway, N-5021

Sponsors and Collaborators
Haukeland University Hospital
InvestigatorsPrincipal Investigator: Olav Mella, PhD, MD Haukeland University Hospital

More Information

Publications:
Fluge , Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28.
Responsible Party: Department of Oncology and Medical Physics, Haukeland University Hospital ( Olav Mella/ Professor, Department Director )
ClinicalTrials.gov Identifier: NCT01156909 History of Changes
Other Study ID Numbers: 2010/1318
Study First Received: July 2, 2010
Last Updated: July 2, 2010
Health Authority: Norway: Directorate for Health and Social Affairs


Keywords provided by Haukeland University Hospital: Chronic fatigue syndrome
CFS
Myalgic encephalomyelitis
Rituximab
B-cell depletion


Additional relevant MeSH terms: Fatigue
Fatigue Syndrome, Chronic
Encephalomyelitis
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Signs and Symptoms
Virus Diseases Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents