Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2025-12-25 @ 1:59 AM
NCT ID:
NCT00727194
Eligibility Criteria:
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
* A positive serologic test for binding anti-acetylcholine receptor Abs at Screening and one of the following a) history of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation, or b) history of positive anticholinesterase test, eg, edrophonium chloride test, or c) patient has demonstrated improvement in MG signs on acetylcholinesterase inhibitors as assessed by treating physician.
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 chronic 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00727194
Study Brief:
Protocol Section:
NCT00727194