Status:
COMPLETED
Efficacy of Methotrexate in Myasthenia Gravis
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Myasthenia gravis is a rare neuromuscular disorder characterized by weakness and fatigability of ocular, bulbar, and extremity musculature. The specific aim of this study is to determine if oral metho...
Eligibility Criteria
Inclusion
- Patients must have MGFA MG grades 2, 3, or 4 generalized myasthenia gravis, according to the MGFA classification system
- Elevated acetylcholine receptor antibody (AChR-Ab) titer.
- Patient's signs and symptoms should not be better explained by another disease process.
- Prednisone dose of at least 10 mg/day (or the equivalent in alternate days) and the subject must be on a stable dose of prednisone for 30 days prior to the screening visit.
Exclusion
- 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 patients who are premenopausal and are: (a) pregnant on the basis of a serum pregnancy test, (b) breast-feeding, or (c) not using an effective method of double barrier (1 hormonal plus 1 barrier method or 2 simultaneous barrier methods) 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.
- Evidence of thymoma on chest CT or MRI. Such a finding could require immediate thymectomy and would preclude entry into the study.
- Thymectomy in the previous three months.
- Patients who have been medicated with azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, IVIg, or other immunosuppressive drugs within the last 60 days.
- Chest X-ray with evidence of tumor, infection, or interstitial lung disease.
- Clinical history of chronic or recurrent infections.
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
- History of renal or hepatic insufficiency or liver enzymes greater than the 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 predicted.
- MG Grade 1 (ocular only) or 5 (crisis, requiring ventilator).
- Prior use of methotrexate for any condition.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00814138
Start Date
April 1 2009
End Date
January 1 2014
Last Update
May 26 2016
Active Locations (16)
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1
Phoenix Neurological Associates
Phoenix, Arizona, United States, 85018
2
University of California, San Francisco
Fresno, California, United States, 93701
3
University of California-Irvine
Irvine, California, United States, 92697
4
Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115