Myasthenia Gravis MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: LLT Classification code 10028423 Term: Myasthenia gravis-like syndrome System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: HLT Classification code 10071942 Term: Myasthenia gravis and related conditions System Organ Class: 100000004859
Conditions
Sponsors
argenx BVBA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will roll over in this trial only if they meet all of the following criteria: 1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and can comply with the trial protocol procedures. 2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol. Other more specific inclusion criteria are further defined in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients will not roll over in this trial if they meet any of the following criteria: 1. Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued early from randomized treatment for pregnancy or rescue reasons or an (S)AE that might jeopardize the safety of the patient in that trial. 2. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women of childbearing potential (DEFINITION OF TERMS) should have a negative urine pregnancy test at SEB. 3. Male patients who are sexually active and do not intend to use effective methods of contraception (as mentioned above) during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing. 4. Patients with known hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) seropositivity. Other more specific exclusion criteria are further defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of ARGX-113 in acetylcholine receptor antibody (AChR-Ab) seropositive patients.;Secondary Objective: To evaluate the long-term safety and tolerability of ARGX-113 in the overall population (AChR-Ab seropositive and AChR-Ab seronegative patients).;Primary end point(s): Incidence and severity of AEs, serious adverse events (SAEs), vital signs, electrocardiogram (ECG) and laboratory assessments over the duration of the trial in AChR-Ab seropositive patients.;Timepoint(s) of evaluation of this end point: up to maximum 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence and severity of AEs, SAEs, vital signs, ECG and laboratory assessments over the duration of the trial in the overall population (AChR-Ab seropositive patients and AChR-Ab seronegative patients). ;Timepoint(s) of evaluation of this end point: over the duration of the trial (up to maximum 3 years) | — |
Countries
Belgium, Canada, Czechia, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Italy, Japan, Netherlands, Poland, Russian Federation, Serbia, United Kingdom, United States
Contacts
Public ContactRegulatory affairs
argenx BVBA
Outcome results
None listed