Re: Executives Tysabri+ Spasms

[Guest guest]

Tom and all

Thank you Tom for the Biogen article. I had not read this one.

Here is our update after the CA trip.

Our neuro nurse called and cancelled Jacks Tysabri

infusion for Tuesday . We will go to that Dr. on the

15th and discuss chemo until Tysabri is OKed again. This past

month after the Tysabri infusion was great!! We hopped Am Track in CA

with just a back pack went to another city and caught trollies and

buses to historic areas. I never would have believed we could do

it. We are over 60 . Only in the last 5 days he is very

fatigued again and has spasms so bad he has been in bed 2 days. We are

back physically to where we were a month ago. But we have the memory of a

great trip!! I now know why Southern CA is so popular. We went to a

wild animal park and Jack got great animal shots from a Safari truck ln

the habitat.

Coming back through Detroit. our plane was late and we

missed a connection. ALMOST made it We ran for 15 minute from one gate to

another. with carry on luggage. I learned from this ...... One of

us should request a wheel chair!!. We could take turns riding or

pushing and who ever sits in it holds the carry on luggage. Jack

did not need to push himself so hard. We missed that plane and had a 5

hour wait. Jacks Spasms started after the run and are still going. We are

managing them now. LIVE and LEARN

The main med that helps his spasms is Baclofin with Neurotin

.. He needs 2 Baclofin at bed time. He is on Betaseron shots every

other day. Now that he is taking it he is better,

I listed the meds that help the spasms since some of you all are

discussing it.

MJ

At 10:55 AM 3/11/2005 -0500, you wrote:

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Biogen won't vouch for

former exec: Co. won't say it thinks Bucknum's innocent

By Brett Arends

Friday, March 11, 2005

[Guest guest]

Hi MJ,

and everyone

I am still waiting for my pharmacy to finish preparing my LDN.

However, I almost had joined a group researching Rituxan.

Or perhaps my Dr. would have prescribed it without participating in the Phase II trial before I convinced him to let me try LowDoseNaltrexone.

I have previously seen a web article speaking of Rituxan with Tsabri like promising results. I understand that this drug would be an infusion, but I believe that anything not chemo is better than chemo, which is why I chose to post this email and trial information.

Recruiting

A Study to Evaluate Rituximab in Adults with Relapsing Remitting Multiple SclerosisCondition: Relapsing Remitting Multiple Sclerosis

Recruiting

A Study to Evaluate the Safety and Efficacy of Rituximab in Adults with Primary Progressive Multiple SclerosisCondition: Primary Progressive Multiple Sclerosis

Home

|

Search

|

Browse

|

Resources

|

Help

|

What's New

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About

A Study to Evaluate Rituximab in Adults with Relapsing Remitting Multiple Sclerosis

This study is currently recruiting patients.

Sponsored by:

Genentech

Information provided by:

Genentech

Purpose

This is a phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with Relapsing-Remitting Multiple Sclerosis (RRMS).

Condition

Treatment or Intervention

Phase

Multiple Sclerosis

Drug: Rituxan (rituximab)

Phase II

MedlinePlus related topics: Multiple Sclerosis

Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase II, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults with Relapsing Remitting Multiple Sclerosis

Eligibility

Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both

Criteria

INCLUSION CRITERIA:

Ability and willingness to provide written informed consent and to comply with the schedule of protocol assessments Age 18 to 55 years, inclusive Diagnosis of relapsing MS, as defined by Mc Criteria 1 through 4 (Mc et al. 2001) History of at least one relapse in the subject’s medical records during the 1 year prior to randomization Expanded Disability Status Scale (EDSS) at screening between 0 and 5.0 points, inclusive For subjects of reproductive potential (males and females), ability and willingness to use a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) during the study, including the safety follow-up period, and for up to 1 year after their last dose of study drug, even if they have discontinued early from the study

EXCLUSION CRITERIA:

General Health:

Pregnancy or lactation Incompatibility with MRI Lack of peripheral venous access History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies Known active bacterial, viral, fungal, or mycobacterial infection, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds or recurrent herpes infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, or syphilis) History of cancer, including solid tumors and hematologic malignancies (except fully resolved and resected cutaneous basal cell and squamous cell carcinomas of the skin and cancer in situ of the cervix) History of alcohol or drug abuse within 6 months prior to screening History of or currently active primary or secondary immunodeficiency Presence of significant, uncontrolled disease of the cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal systems

Neurologic Disease:

Diagnosis of secondary progressive, primary progressive, or progressive relapsing MS History or presence of vascular disease potentially affecting brain or spinal cord (e.g., stroke, transient ischemic attack, severe carotid stenosis, aortic aneurysm, intracranial aneurysm, hemorrhage, arteriovenous malformation) History or presence of myelopathy due to spinal cord compression by disk or vertebral disease History of severe, clinically significant central nervous system (CNS) trauma (e.g., cerebral contusion, spinal cord compression) History of intracranial or intraspinal tumor (e.g., meningioma, glioma) History or presence of potential metabolic cause of encephalopathy or myelopathy (e.g., untreated vitamin B12 deficiency, untreated thyroid deficiency) History or presence of infectious causes of encephalopathy or myelopathy (e.g., syphilis, Lyme disease, human T-cell lymphotropic virus type 1 [HTLV 1], herpes zoster myelopathy) Neuromyelitis optica History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, antiphospholipid antibody syndrome, Sjögren’s syndrome, Behcet disease) History or presence of sarcoidosis Relapse within 30 days prior to randomization

Medications:

Previous treatment with Rituximab (MabThera/Rituxan) Treatment with any investigational agent within 90 days of screening or five half lives of the investigational drug (whichever is longer) Receipt of a live vaccine within 30 days prior to randomization Previous treatment with lymphocyte-depleting therapies (e.g., cyclophosphamide, Campath, anti-CD4, cladribine, total body irradiation, bone marrow transplantation) Treatment with mitoxantrone within 12 months of randomization Systemic corticosteroid therapy within 30 days of randomization Treatment with IFN-B or Copaxone within 60 days of randomization Treatment with IVIG within 60 days of randomization Plasmapheresis within 60 days of randomization Treatment with minimally or non–lymphocyte depleting immunosuppressive therapies (e.g., mycophenolate mofetil, cyclosporine, methotrexate, azathioprine) within 90 days of randomization Statins or hormone replacement therapy started within 30 days of randomization

Laboratory Findings:

Positive pregnancy test B-cell count below the lower limit of normal at screening Vitamin B12 below the lower limit of normal with an abnormal methylmalonic acid level Positive rapid plasma reagin Serum creatinine >1.4 mg/dL for women or >1.6 mg/dL for men Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) >2.5× the upper limit of normal Platelet count <100,000/mL Hemoglobin <8.5 g/dL Neutrophils <1.5 ×10(3)/mL Serum IgG levels below 5.65 mg/mL and serum IgM levels below 0.55 mg/mL Findings on brain MRI scan consistent with clinically significant conditions other than MS Electrocardiogram (ECG) showing significant abnormality that, the treating investigator determines, may jeopardize the subject’s health (i.e., acute ischemia, left bundle branch, or bifascicular block)

Location and Contact Information

Hamirani Ext. 72285 hamirani.sarah@...

Arizona Phoenix Neurological Associates, Ltd., Phoenix, Arizona, 85006, United States; Recruiting Lynn E. Flynn Florida Neurological Services of Orlando, Orlando, Florida, 32806, United States; Recruiting Sharon Koch-Parrish Ext. 25 Montana Deaconess Billings Clinic Reasearch Div, Billings, Montana, 59101, United States; Recruiting Carol Whittle, RN, CCRC North Carolina Raleigh Neurology Associates, PA, Raleigh, North Carolina, 27607, United States; Recruiting Beth , LPN Texas Neurology Clinic of San , San , Texas, 78229, United States; Recruiting Charlie Hill, RN, BSN

More Information

Study ID Numbers: U2787gRecord last reviewed: November 2004Last Updated: November 19, 2004Record first received: November 18, 2004ClinicalTrials.gov Identifier: NCT00097188Health Authority: United States: Food and Drug AdministrationClinicalTrials.gov processed this record on 2005-03-11

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services

Copyright, Privacy, Accessibility, Freedom of Information Act

[Guest guest]



When you get into a trial program like this one does your insurance have to pay for it or is it free to trial members?

Bill

Re: Executives Tysabri+ Spasms

Hi MJ,

and everyone

I am still waiting for my pharmacy to finish preparing my LDN.

However, I almost had joined a group researching Rituxan.

Or perhaps my Dr. would have prescribed it without participating in the Phase II trial before I convinced him to let me try LowDoseNaltrexone.

I have previously seen a web article speaking of Rituxan with Tsabri like promising results. I understand that this drug would be an infusion, but I believe that anything not chemo is better than chemo, which is why I chose to post this email and trial information.

Recruiting

A Study to Evaluate Rituximab in Adults with Relapsing Remitting Multiple SclerosisCondition: Relapsing Remitting Multiple Sclerosis

Recruiting

A Study to Evaluate the Safety and Efficacy of Rituximab in Adults with Primary Progressive Multiple SclerosisCondition: Primary Progressive Multiple Sclerosis

Home

|

Search

|

Browse

|

Resources

|

Help

|

What's New

|

About

A Study to Evaluate Rituximab in Adults with Relapsing Remitting Multiple Sclerosis

This study is currently recruiting patients.

Sponsored by:

Genentech

Information provided by:

Genentech

Purpose

This is a phase II, randomized, double-blind, parallel group, placebo controlled, multicenter study to evaluate the safety and efficacy of Rituximab in adults with Relapsing-Remitting Multiple Sclerosis (RRMS).

Condition

Treatment or Intervention

Phase

Multiple Sclerosis

Drug: Rituxan (rituximab)

Phase II

MedlinePlus related topics: Multiple Sclerosis

Study Type: InterventionalStudy Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase II, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults with Relapsing Remitting Multiple Sclerosis

Eligibility

Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both

Criteria

INCLUSION CRITERIA:

Ability and willingness to provide written informed consent and to comply with the schedule of protocol assessments Age 18 to 55 years, inclusive Diagnosis of relapsing MS, as defined by Mc Criteria 1 through 4 (Mc et al. 2001) History of at least one relapse in the subject’s medical records during the 1 year prior to randomization Expanded Disability Status Scale (EDSS) at screening between 0 and 5.0 points, inclusive For subjects of reproductive potential (males and females), ability and willingness to use a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) during the study, including the safety follow-up period, and for up to 1 year after their last dose of study drug, even if they have discontinued early from the study

EXCLUSION CRITERIA:

General Health:

Pregnancy or lactation Incompatibility with MRI Lack of peripheral venous access History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies Known active bacterial, viral, fungal, or mycobacterial infection, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds or recurrent herpes infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 30 days prior to screening or oral antibiotics within 14 days prior to screening History or presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, or syphilis) History of cancer, including solid tumors and hematologic malignancies (except fully resolved and resected cutaneous basal cell and squamous cell carcinomas of the skin and cancer in situ of the cervix) History of alcohol or drug abuse within 6 months prior to screening History of or currently active primary or secondary immunodeficiency Presence of significant, uncontrolled disease of the cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal systems

Neurologic Disease:

Diagnosis of secondary progressive, primary progressive, or progressive relapsing MS History or presence of vascular disease potentially affecting brain or spinal cord (e.g., stroke, transient ischemic attack, severe carotid stenosis, aortic aneurysm, intracranial aneurysm, hemorrhage, arteriovenous malformation) History or presence of myelopathy due to spinal cord compression by disk or vertebral disease History of severe, clinically significant central nervous system (CNS) trauma (e.g., cerebral contusion, spinal cord compression) History of intracranial or intraspinal tumor (e.g., meningioma, glioma) History or presence of potential metabolic cause of encephalopathy or myelopathy (e.g., untreated vitamin B12 deficiency, untreated thyroid deficiency) History or presence of infectious causes of encephalopathy or myelopathy (e.g., syphilis, Lyme disease, human T-cell lymphotropic virus type 1 [HTLV 1], herpes zoster myelopathy) Neuromyelitis optica History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, antiphospholipid antibody syndrome, Sjögren’s syndrome, Behcet disease) History or presence of sarcoidosis Relapse within 30 days prior to randomization

Medications:

Previous treatment with Rituximab (MabThera/Rituxan) Treatment with any investigational agent within 90 days of screening or five half lives of the investigational drug (whichever is longer) Receipt of a live vaccine within 30 days prior to randomization Previous treatment with lymphocyte-depleting therapies (e.g., cyclophosphamide, Campath, anti-CD4, cladribine, total body irradiation, bone marrow transplantation) Treatment with mitoxantrone within 12 months of randomization Systemic corticosteroid therapy within 30 days of randomization Treatment with IFN-B or Copaxone within 60 days of randomization Treatment with IVIG within 60 days of randomization Plasmapheresis within 60 days of randomization Treatment with minimally or non–lymphocyte depleting immunosuppressive therapies (e.g., mycophenolate mofetil, cyclosporine, methotrexate, azathioprine) within 90 days of randomization Statins or hormone replacement therapy started within 30 days of randomization

Laboratory Findings:

Positive pregnancy test B-cell count below the lower limit of normal at screening Vitamin B12 below the lower limit of normal with an abnormal methylmalonic acid level Positive rapid plasma reagin Serum creatinine >1.4 mg/dL for women or >1.6 mg/dL for men Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) >2.5× the upper limit of normal Platelet count <100,000/mL Hemoglobin <8.5 g/dL Neutrophils <1.5 ×10(3)/mL Serum IgG levels below 5.65 mg/mL and serum IgM levels below 0.55 mg/mL Findings on brain MRI scan consistent with clinically significant conditions other than MS Electrocardiogram (ECG) showing significant abnormality that, the treating investigator determines, may jeopardize the subject’s health (i.e., acute ischemia, left bundle branch, or bifascicular block)

Location and Contact Information

Hamirani Ext. 72285 hamirani.sarah@...

Arizona Phoenix Neurological Associates, Ltd., Phoenix, Arizona, 85006, United States; Recruiting Lynn E. Flynn Florida Neurological Services of Orlando, Orlando, Florida, 32806, United States; Recruiting Sharon Koch-Parrish Ext. 25 Montana Deaconess Billings Clinic Reasearch Div, Billings, Montana, 59101, United States; Recruiting Carol Whittle, RN, CCRC North Carolina Raleigh Neurology Associates, PA, Raleigh, North Carolina, 27607, United States; Recruiting Beth , LPN Texas Neurology Clinic of San , San , Texas, 78229, United States; Recruiting Charlie Hill, RN, BSN

More Information

Study ID Numbers: U2787gRecord last reviewed: November 2004Last Updated: November 19, 2004Record first received: November 18, 2004ClinicalTrials.gov Identifier: NCT00097188Health Authority: United States: Food and Drug AdministrationClinicalTrials.gov processed this record on 2005-03-11

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services

Copyright, Privacy, Accessibility, Freedom of Information Act

[Guest guest]

Hi,

Thank you all for the new info. We will check into it. One of the NC

sites is not to far away. Jack's age is 60 so that may preclude him . I an

interested in all of this Thank you. You all are " cutting edge " good

Tuesday we will go to Bowman Gray ,Wake Forest in Winstom Salem NC to Dr

Jefferies. It will be interesting to get updated on things. We will spend

a night at our daughter' s but as soon as I'm near the computer I will let

you all know how things went. Jack is better today.

Proper management of medication makes a difference too. Hard to do when

you are wiped out. MJ