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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01179893
Eligibility Criteria:
Inclusion Criteria:
* \>18 years old
* diagnosis of moderate-severe MG (defined as a Quantitative Myasthenia Gravis Score QMGS \>10.5)
* worsening weakness requiring a change in therapy judged by a neuromuscular expert
Exclusion Criteria:
* Worsening weakness secondary to concurrent medications (e.g. Aminoglycosides)
* Worsening weakness secondary to infection
* Change in corticosteroid dosage in the 2 weeks prior to screening
* Other disorders causing weakness or fatigue
* Known absolute IgA deficiency (risk of anaphylactic reaction to IVIG)
* History of anaphylaxis or severe systemic response to IVIG or albumin
* Pregnancy or breastfeeding
* Active renal failure precluding volume of IVIG (risk of volume overload with IVIG) as judged by the investigators
* Clinically significant cardiac disease precluding IVIG volume as judged by the investigators
* Known hyperviscosity or hypercoaguable state (risk of stroke with IVIG)
* Known coagulopathy with bleeding
* On another current study medication or protocol within 4 weeks of screening
* Patients with known refractory status to either IVIG or PLEX
* Poorly controlled or severe hypertension (exacerbation by IVIG)
* Patient refuses treatment with either IVIG or PLEX
* Patient refuses follow-up with electrophysiological studies
* Patient unable or unwilling to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01179893
Study Brief:
Protocol Section:
NCT01179893