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:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT01927692
Eligibility Criteria:
Inclusion Criteria:
* has the capacity to understand and sign an informed consent form
* 18 years or older
* diagnosis of MG based on clinical features
* has detectable serum autoantibodies to AChR
* has a clinical indication for the use of TPE to treat MG
Exclusion Criteria:
* unable or unwilling to comply with study procedures that include multiple venipunctures
* weighs less than 50Kg
* has a contraindication to treatment with TPE (e.g. clinically significant bleeding disorder)
* has muscle specific tyrosine kinase or low-density lipoprotein receptor-related protein 4 (LRP4) antibody positive MG
* has prior or current history of thymoma
* had a thymectomy in the past 6 months
* has received rituximab in the past 12 months
* has another coexisting autoimmune disease that is not clinically controlled or may preclude accurate study assessments according to the judgment of the PI
* has current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or central nervous system disease
* has participated in an interventional clinical trial with a novel therapeutic agent in the past 6 months
* is cognitively impaired, a prisoner, or otherwise institutionalized at the time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01927692
Study Brief:
Protocol Section:
NCT01927692