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Immune Factor Rituximab on Immune Function in ME/CFS

Discussion in 'Active Clinical Studies' started by Cort, Jun 15, 2009.

  1. Cort

    Cort Phoenix Rising Founder

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    Raleigh, NC
    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
     
  2. Cort

    Cort Phoenix Rising Founder

    Messages:
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    Likes:
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    Raleigh, NC
    Kristin Loomis at the HHV6 Foundation is really interested in this drug. Actually several researchers seem to be. :)
     
  3. kg1

    kg1

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    Bump and does anyone have an update
     
  4. jackie

    jackie Senior Member

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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
     
  5. Dolphin

    Dolphin Senior Member

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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

     

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