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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT00997412
Eligibility Criteria:
Inclusion Criteria:
* Male or female age between 20-70 (including 20 and 70 years old).
* Osserman II and III Myasthenia Gravis.
* Positive serum anti-acetylcholine receptor antibodies.
* Poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment.
* Without immunosuppressive therapy other than steroid.
Exclusion Criteria:
* Ocular MG or minimal clinical syndrome that would not require the therapy of steroids.
* Negative serum anti-acetylcholine receptor antibodies.
* Use immunosuppressants other than steroids in the preceding year.
* Previous use other investigational medication within 3 months or current participate other clinical study.
* Poor renal function: serum creatinine \> 3.0 mg/dl or estimated creatinine clearance \< 30 ml/min
* Females who are pregnancy or breast-feeding.
* Recent history, within 5 years, of malignancy
* Unwilling or unable to participate the necessary continuous visits and examinations.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT00997412
Study Brief:
Protocol Section:
NCT00997412