Spots Global Cancer Trial Database for Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
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Trial Identification
Brief Title: Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
Official Title: A Long-Term, Single-Arm, Open-label, Multicenter Phase 3 Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Patients With Generalized Myasthenia Gravis
Study ID: NCT04818671
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigator site 6 - US0010032, Carlsbad, California, United States
Investigator Site 47 - US0010021, Palo Alto, California, United States
Investigator Site 45 - US0010108, Boca Raton, Florida, United States
Investigator site 4 - US0010110, Port Charlotte, Florida, United States
Investigator Site 39 - US0010006, Tampa, Florida, United States
Investigator Site 41 - US0010015, Kansas City, Kansas, United States
Investigator Site 46 - US0010111, Amherst, New York, United States
Investigator Site 38 - US0010003, Chapel Hill, North Carolina, United States
Investigator Site 44 - US0010077, Durham, North Carolina, United States
Investigator Site 42 - US0010019, Cleveland, Ohio, United States
Investigator site 7 - US0010008, Cordova, Tennessee, United States
Investigator Site 43 - US0010066, Austin, Texas, United States
Investigator Site 40 - US0010009, San Antonio, Texas, United States
Investigator site 5 - BE0320007, Gent, , Belgium
Investigator site 24 - CZ4200005, Brno, , Czechia
Investigator site 2 - GEO9950002, Tbilisi, , Georgia
Investigator Site 1 - GEO9950001, Tbilisi, , Georgia
Investigator site 3 - GEO9950003, Tbilisi, , Georgia
Investigator Site 32 - GEO9950004, Tbilisi, , Georgia
Investigator Site 33 - GEO9950016, Tbilisi, , Georgia
Investigator Site 25 - DE490006, Berlin, , Germany
Investigator Site 26 - DE490009, Münster, , Germany
Investigator site 10 - HU0360013, Budapest, , Hungary
Investigator site 9 - HU0360012, Budapest, , Hungary
Investigator site 11 - IT0390003, Milano, , Italy
Investigator Site 34 - IT0390007, Napoli, , Italy
Investigator Site 35 - IT0390008, Roma, , Italy
Investigator site 12 - JP0810002, Chiba, Chiba-Shi, Japan
Investigator Site 36 - JP0810055, Sapporo, Hokkaido, Japan
Investigator site 8 - JP0810004, Hanamaki, Iwate, Japan
Investigator Site 28- JP0810059, Ota-Ku, Tokyo, Japan
Investigator site 14 - JP0810007, Osaka, , Japan
Investigator Site 27 - JP0810008, Sapporo, , Japan
Investigator site 13 - JP0810005, Sendai-shi, , Japan
Investigator site 15 - JP0810009, Tokyo, , Japan
Investigator site 16 - NL0310001, Leiden, , Netherlands
Investigator site 17 - PL0480001, Gdańsk, , Poland
Investigator site 19 - PL0480007, Katowice, , Poland
Investigator site 22 - PL0480065, Kraków, , Poland
Investigator site 18 - PL0480005, Kraków, , Poland
Investigator site 20 - PL0480018, Lublin, , Poland
Investigator site 21 - PL0480022, Warsaw, , Poland
Investigator Site 29- RU0070002, Novosibirsk, , Russian Federation
Investigator Site 30 - RU0070014, Saint Petersburg, , Russian Federation
Investigator Site 37 - ES0340021, Barcelona, , Spain
Investigator Site 31 - ES0340038, Barcelona, , Spain
Investigator site 23 - ES0340039, Valencia, , Spain
Contact Details
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