A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
A legfontosabb adatok
- Hol
- Atlanta, Austin, Baltimore, Beverly Hills, Chapel Hill, Chicago, Columbus, Gainesville, Great Neck, Houston, Jacksonville, New Haven, Orange, Phoenix, Pittsburgh, Portland, San Francisco és Tampa (Egyesült Államok)Mind a 18 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Emory Healthcare - Emory Clinic - RheumatologyAtlanta, Egyesült ÁllamokNo longer taking part
- Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLCAustin, Egyesült ÁllamokNo longer taking part
- John Hopkins Medicine - Johns Hopkins Myositis CenterBaltimore, Egyesült ÁllamokNo longer taking part
- Attune Health Research IncBeverly Hills, Egyesült ÁllamokNo longer taking part
- University of North Carolina (UNC) School of MedicineChapel Hill, Egyesült ÁllamokNo longer taking part
- Northwestern Medicine - Northwestern Memorial HospitalChicago, Egyesült ÁllamokNo longer taking part
- The Ohio State UniversityColumbus, Egyesült ÁllamokNo longer taking part
- UF Health - Rheumatology Medical Specialties Medical PlazaGainesville, Egyesült ÁllamokNo longer taking part
- Northwell Health Physician Partners RheumatologyGreat Neck, Egyesült ÁllamokNo longer taking part
- Nerve and Muscle Center of TexasHouston, Egyesült ÁllamokNo longer taking part
- Mayo Clinic - Florida - NeurologyJacksonville, Egyesült ÁllamokNo longer taking part
- Yale Cancer Center-Yale University School Of MedicineNew Haven, Egyesült ÁllamokNo longer taking part
- UCI Health - ALS and Neuromuscular Center - NeurologyOrange, Egyesült ÁllamokNo longer taking part
- Neuromuscular Clinical and Research Center - NeurologyPhoenix, Egyesült ÁllamokNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, Egyesült ÁllamokNo longer taking part
- Oregon Health and Science UniversityPortland, Egyesült ÁllamokNo longer taking part
- UCSF Health - ALS and Neurodegenerative Disease Center - DermatologySan Francisco, Egyesült ÁllamokNo longer taking part
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)Tampa, Egyesült ÁllamokNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- argenx
- Azonosító
- NCT05979441EU 2022-502851-79-00
- A regiszteradat frissítve
- 2026. október 16.
- Eredeti leírás
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.A teljes eredeti leírásKevesebb
A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007.
The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.
Bevonási feltételek: Has completed trial ARGX-113-2007; Being capable of providing signed informed consent and complying with protocol requirements; Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug.
Kizáró feltételek: Intention to have major surgery during the study period or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk; Known hypersensitivity reaction to the study drug or 1 of its excipients; Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness.