A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX 113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness
- Conditions
- Generalized Muscle WeaknessMyasthenia Gravis10003816
- Registration Number
- NL-OMON55635
- Lead Sponsor
- argenx BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
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 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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence and severity of AEs, serious adverse events (SAEs), vital signs,<br /><br>electrocardiogram (ECG) and laboratory assessments over 3 year in<br /><br>AChR-Ab seropositive patients</p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence and severity of AEs, SAEs, vital signs, ECG and laboratory<br /><br>assessments over the duration of the trial in the overall population (AChR-Ab<br /><br>seropositive patients and AChR-Ab seronegative patients).</p><br>