Steward Health Care System

Return to Results

A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Tr

new search

Trial Conditions
  • Myasthenia Gravis
What is the purpose of this trial?

The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 80 

Gender:
Both

Eligibility

Inclusion Criteria:

- Generalized MG

- MGFA Clinical Classification Class II, III or IVa.

- QMG total score ≥12

- Minimum score of two (2) in four (4) or more test items in the QMG

- Able to give informed consent.

- Have failed at least two immunosuppressants after one year of treatment

Exclusion Criteria:

- History of thymoma or other neoplasms of the thymus.

- History of thymectomy within 12 months prior to screening.

- Pregnancy or lactation

- Current or onic use of plasmapheresis/plasma exchange

- IVIG treatment within 8 weeks prior to screening.

- Use of etanercept within 2 months prior to screening.

- Use of rituximab (RITUXAN®) within 6 months prior to screening.

- MGFA Class I, IVb, and V

- Crisis or impending crisis

Gender: Both
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • eculizumab
  • Placebo
Other Information

Sponsor: Alexion Pharmaceuticals
Phase: Phase 2
Trial ID: NCT00727194
Volunteers:  Not Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions