BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - 90
Updated:11/9/2018
Start Date:May 2014
End Date:May 2018

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B Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia Gravis

The specific primary objective of this study is to determine whether rituximab is a safe and
beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III
efficacy trial.

Investigators plan on conducting a multicenter randomized, double-blind, placebo controlled
Phase II clinical trial utilizing a futility design. The study would include acetylcholine
receptor (AChR) antibody positive generalized MG subjects. This study also presents a unique
opportunity to study both drug and disease mechanisms because unlike many other autoimmune
diseases in which rituximab has been used, MG affords the investigation of antigen-specific
components that participate in the immunopathology of the disease, namely autoantibodies,
autoantibody-producing B cells, and antigen-specific T cells. This work will further our
understanding of MG immunopathology and it represents the first step toward gaining a more
complete understanding of the immune mechanisms underlying treatment of MG with rituximab
leading to new ways to treat the disease.

The specific aim of this study is to determine whether rituximab is a safe and effective
treatment for subjects with MG.

The SNOMED code for MG is 31839002.

Inclusion Criteria:

1. Subjects 21 to 90 years old

2. Subjects must have generalized MG, defined as MGFA clinical classification grades 2
(mild), 3 (moderate), or 4 (severe, but not intubated) at the time of
screening/randomization.

3. Elevated AChR antibody titer

4. Subject's signs and symptoms should not be better explained by another disease
process.

5. Subjects must be on a stable standard immunosuppressive regimen:

1. Prednisone only: Prednisone dose must be at least 15mg/day (or the equivalent on
alternate days), and the dose of prednisone must have been stable for at least 4
weeks (28 days) prior to the baseline visit.

2. Prednisone plus another immunosuppressive therapy (IST). Immunosuppressive
therapies other than prednisone, specifically azathioprine, mycophenolate
mofetil, cyclosporine, tacrolimus or methotrexate, are permitted, but the dose
must have been stable for at least 6 months prior to the baseline visit.

(Note: The prednisone dose must be stable as defined in the prednisone only group. The
IST dose must remain stable throughout the course of the study).

6. Subjects must be willing to complete the study and return for follow-up visits.

7. 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.

8. Able and willing to give written informed consent and comply with the requirements of
the study protocol.

9. 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.

10. 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
treatment.

Exclusion Criteria:

1. A history of chronic degenerative, psychiatric, or neurologic disorder other than MG
that can produce weakness or fatigue.

2. Other major chronic or debilitating illnesses within six months prior to study entry.

3. 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).

4. Altered levels of consciousness, dementia, or abnormal mental status.

5. Thymectomy in the previous six months.

6. Subjects who have been medicated with immunosuppressive drugs not listed in inclusion
#5 within the last 8 weeks (56 days) prior to the baseline visit

7. Subjects who have been medicated with an immunosuppressive agent such as azathioprine,
mycophenolate mofetil, cyclosporine, tacrolimus or methotrexate, that is withdrawn
within 8 weeks (56 days) of the Baseline Visit.

8. Subjects who have received IVIg or PLEX treatment within the last 4 weeks (28 days)
prior to the baseline visit.

9. Unstable dose or a stable dose of > 480 mg/day of pyridostigmine in 2 weeks prior to
screening visit.

10. Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).

11. History of renal or hepatic insufficiency or elevated liver enzymes (AST or ALT >2.5 x
Upper Limit of Normal).

12. History of bone marrow hypoplasia, leucopenia, thrombocytopenia, significant anemia,
clinical or laboratory evidence of immunodeficiency syndromes.

13. Forced Vital Capacity (FVC) <50% of percent predicted.

General Safety & Laboratory Exclusion Criteria

14. ANC < 1.5 x 103 cells/microliter

15. Hemoglobin: < 8.0 gm/dL

16. Platelets: < 100,000/mm

17. Positive Hepatitis B or C serology (Hep B surface antigen and Hep C antibody)

18. History of positive HIV (HIV conducted during screening if applicable)

19. Treatment with any investigational agent within 4 weeks of screening or 5 half-lives
of the investigational drug (whichever is longer)

20. Receipt of a live vaccine within 4 weeks prior to randomization

21. Previous treatment with rituximab (MabThera® / Rituxan®)

22. Previous treatment with natalizumab (Tysabri®)

23. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies

24. History of recurrent significant infection or history of recurrent bacterial
infections

25. 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

26. Unstable steroid dose in the past 4 weeks (28 days)

27. Lack of peripheral venous access

28. History of drug, alcohol, or chemical abuse within 6 months prior to screening

29. 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
cervix or prostate.

30. History of psychiatric disorder that would interfere with normal participation in this
protocol

31. Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

32. 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
complications

33. 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/day on average.

34. Prednisone dose of more than 100 mg/day (or 200 mg over a two day period).
We found this trial at
26
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Tessa Marburger, MD
Phone: 503-494-7269
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vita Kesner, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Mohammad Alsharabati, MD
Phone: 205-975-0445
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Anthony A Amato, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Volkan Granit, MD
Phone: 718-920-6690
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
Principal Investigator: Yaacov Anziska, MD
Phone: 718-270-7786
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Perry B Shieh, MD, PhD
Phone: 310-206-9089
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Arya Puwanant
Phone: 412-681-2000
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Emma Ciafaloni, MD
Phone: 585-276-3037
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: A. Gordan Smith, MD
Phone: 801-581-3818
University of Utah Research is a major component in the life of the U benefiting...
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Buffalo, New York 14209
Principal Investigator: Gil Wolfe, MD
Phone: 716-859-7510
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Ted Michael Burns, MD
Phone: 434-982-6961
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Laura A Sams, MD
Phone: 513-558-5023
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: John T Kissel, MD
Phone: 614-366-9050
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Sharon Nations, MD
Phone: 214-648-9275
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Davis, California 95616
Principal Investigator: David P Richman, MD
Phone: 916-734-4303
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Denver, Colorado 80291
Principal Investigator: Dianna Quan, MD
Phone: 303-724-3736
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Evanston, Illinois 60208
Principal Investigator: Senda Ajroud-Driss, MD
Phone: 312-695-8636
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Mazen Dimachkie, MD
Phone: 913-945-9922
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Miami, Florida 33136
Principal Investigator: Michael Benatar, MD
Phone: 305-243-3799
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New Haven, Connecticut 06510
Principal Investigator: Richard J Nowak, MD, MS
Phone: 203-737-7095
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New York, New York 10065
Principal Investigator: Jonathan M. Goldstein, MD
Phone: 646-797-8657
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Thomas H Brannagan, MD
Phone: 212-305-6035
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Saint Louis, Missouri 63110
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Eric Gierke, MD
Phone: 206-320-7115
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Stony Brook, New York 11794
Principal Investigator: Nurcan Gursoy, MD
Phone: 631-444-8068
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