Efficacy of Methotrexate in Myasthenia Gravis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00814138
• Date of registration: 23/12/2008
• Prospective Registration: Yes
• Primary sponsor: University of Kansas Medical Center
• Public title: Efficacy of Methotrexate in Myasthenia Gravis
• Scientific title: Phase II Trial of Methotrexate in Myasthenia Gravis
• Date of first enrolment: April 2009
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00814138
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Richard Barohn, MD
• Affiliation: University of Kansas Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Other: Placebo

Drug: Methotrexate

Primary Outcome(s)

Total Prednisone Dose Area Under the Curve [Time Frame: 9 months]

Secondary Outcome(s)

MG Composite Change Over 12 Months [Time Frame: Change from Baseline to Month 12]

MG-ADL 12 Month Change [Time Frame: Change from Baseline to Month 12]

MGQOL 12 Month Change [Time Frame: Change from Baseline to Month 12]

Average Prednisone Daily Dose (mg/Day) [Time Frame: Total length of time daily dose information was collected, i.e. 9 months.]

Manual Muscle Testing 12 Month Change [Time Frame: Change from Baseline to Month 12]

Quantitative Myasthenia Gravis (QMG) Score [Time Frame: Change from Baseline to Month 12]

Secondary ID(s)

11552

FDA OOPD 003538

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00814138