Phase II Trial of Rituximab In Myasthenia Gravis
Diseases and Conditions Researched
Click here for detailed participation information for this trial.
|Dates:||April 7, 2014|
|Last Updated:||May 9, 2014|
- Subjects 21 to 90 years old
- Subjects must have MGFA MG grades 2, 3, or 4 generalized MG, according to the MGFA
classification system. These grades correspond to mild (2), moderate (3), and severe
- Elevated AChR antibody titer
- Subject's signs and symptoms should not be better explained by another disease
- Prednisone dose of at least 15 mg/day (or the equivalent in alternate days) and the
subject must be on a stable dose of prednisone for 4 weeks (28 days) prior to the
- Subjects must be willing to complete the study and return for follow-up visits.
- No history of thymoma, tumor, infection, or interstitial lung disease on chest CT,
MRI, or chest x-ray. Note: Chest x-ray will be completed at screening to look of
interstitial lung disease. A chest CT or MRI to evaluate for thymoma must be
completed as part of prescreening.
- Able and willing to give written informed consent and comply with the requirements of
the study protocol.
- Subjects must be able to give written informed consent before participating in this
study. A copy of the signed consent must be kept in the subject's medical record.
- Men and women of reproductive potential must agree to use an acceptable method of
birth control during treatment and for twelve months (1 year) after completion of
- A history of chronic degenerative, psychiatric, or neurologic disorder other than MG
that can produce weakness or fatigue.
- Other major chronic or debilitating illnesses within six months prior to study entry.
- Female subjects who are premenopausal and are:
1. pregnant on the basis of a serum pregnancy test,
2. breast-feeding, or
3. not using an effective method of double barrier (1 hormonal plus 1 barrier
method or 2 simultaneous barrier methods) or birth control (birth control
pills, male condom, female condom, intrauterine device, Norplant, tubal
ligation, or other sterilization procedures).
- Altered levels of consciousness, dementia, or abnormal mental status.
- Thymectomy in the previous six months.
- Subjects who have been medicated with azathioprine, cyclosporine, cyclophosphamide,
mycophenolate mofetil, methotrexate, or other immunosuppressive drugs within the last
8 weeks (56 days).
- Unstable dose or a stable dose of > 240 mg/day of pyridostigmine in 4 weeks prior to
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
- History of renal or hepatic insufficiency or elevated liver enzymes (AST or ALT >2.5
x Upper Limit of Normal).
- History of bone marrow hypoplasia, leucopenia, thrombocytopenia, significant anemia,
clinical or laboratory evidence of immunodeficiency syndromes.
- Forced Vital Capacity (FVC) <50% of percent predicted.
- ANC < 1.5 x 103 cells/microliter
- Hemoglobin: < 8.0 gm/dL
- Platelets: < 100,000/mm
- Positive Hepatitis B or C serology (Hep B surface antigen and Hep C antibody)
- History of positive HIV (HIV conducted during screening if applicable)
- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives
of the investigational drug (whichever is longer)
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous treatment with rituximab (MabThera® / Rituxan®)
- Previous treatment with natalizumab (Tysabri®)
- History of severe allergic or anaphylactic reactions to humanized or murine
- History of recurrent significant infection or history of recurrent bacterial
- Known active bacterial, viral fungal mycobacterial, or other infection (including
tuberculosis or atypical mycobacterial disease, but excluding fungal infections of
nail beds) or any major episode of infection requiring hospitalization or treatment
with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks
prior to screening
- Unstable steroid dose in the past 4 weeks (28 days)
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening.
- Concomitant malignancies or previous malignancies, with the exception of adequately
treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the
- History of psychiatric disorder that would interfere with normal participation in
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the subject at high risk from treatment
- Subjects that do not record daily prednisone doses for at least 28 days before the
Baseline visit, or subjects whose prednisone dose varies by =6mg.
|Dates:||April 7, 2014|
|Last Updated:||May 9, 2014|
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