The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Daily subcutaneous (SC) injection
Incidence of treatment-emergent adverse events (TEAEs)
A treatment-emergent adverse event is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication.
Time frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 36 months)
Change from Baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
The MG-ADL profile provides an assessment of MG symptom severity and measures 8 items on a 0-3 scale, with 0 being the least severe. The total sum of the 8 items represents the ADL score. The ADL score can range from 0 (least severe) to 24 (most severe).
Time frame: From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the the Quantitative Myasthenia Gravis (QMG) Score
The QMG test is a standardized quantitative strength scoring system and measures 13 items on a 0-3 scale, with 0 being the least severe. The total sum of the 13 items represents the QMG score. The QMG score can range from 0 (least severe) to 39 (most severe).
Time frame: From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the Myasthenia Gravis Composite (MGC) Score
The MGC is a 10-item scale that has been used to measure the clinical status of patients with Myasthenia Gravis (MG) in order to evaluate treatment response. The MGC has 4-point Likerttype Scale response options ranging from 0 to 2, 3, 4, 5, 6 or 9 according to the item (weighted response options). The total score is the sum of all items (range 0-50) where higher scores indicate more severe impairment due to the disease.
Time frame: From Baseline (Day 1) to Week 12
Change from Baseline to Week 12 in the Myasthenia Gravis - Quality of Life revised (MG-QOL15r) Score
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Mg0011 41
Mobile, Alabama, United States
Mg0011 116
Phoenix, Arizona, United States
Mg0011 31
Irvine, California, United States
MG0011 4
Los Angeles, California, United States
Mg0011 220
Pasadena, California, United States
Mg0011 160
San Francisco, California, United States
Mg0011 24
New Haven, Connecticut, United States
Mg0011 27
Washington D.C., District of Columbia, United States
Mg0011 25
Tampa, Florida, United States
Mg0011 135
Augusta, Georgia, United States
...and 60 more locations
The MG-QOL15r is a 15-item survey that was designed to assess quality of life in patients with MG. The MG-QoL has 3-point Likert Scale response options ranging from 0 to 2. The MGQoL15r score can range from 0 to 30, where higher scores indicate more severe impact of the disease on aspects of the patient's life.
Time frame: From Baseline (Day 1) to Week 12