A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
This research study is for adults living with specific muscle conditions, such as myositis, dermatomyositis, or polymyositis. We are looking into a new medication called efgartigimod, given as an injection under the skin. The main goal is to understand if this medicine is safe and effective for long-term use in people who have already tried it in a previous study. Participants will receive the medicine for up to 51 months, and then their health will be checked for two more months after they stop taking it. This helps researchers learn more about how the medicine works over time and if it can improve the lives of those with these conditions.
במבט חטוף
על מה המחקר הזה?
This study is investigating a new medication called efgartigimod, which is given as an injection under the skin, for adults with certain muscle diseases. These diseases are sometimes called idiopathic inflammatory myopathies, which include conditions like dermatomyositis, polymyositis, and immune-mediated necrotizing myopathy. These conditions can cause muscle weakness and other symptoms.
The main purpose of this research is to see how safe and helpful efgartigimod is over a long period. All participants in this study would have already taken part in a previous study for efgartigimod. This follow-up study helps doctors understand the long-term effects of the medication.
By taking part, you would help doctors learn more about this medication. This knowledge could potentially lead to better treatments for people with these challenging muscle conditions in the future.
נקודות עיקריות
- This study evaluates a new medication called efgartigimod for muscle conditions.
- It's a long-term study for adults who participated in a previous trial.
- The medication is given as an injection under the skin.
- The main goals are to check the medication's long-term safety and effectiveness.
- Participation helps future patients with these conditions.
מי עשוי להיות זכאי?
To join this study, you must be an adult aged 18 or older and have previously taken part in a specific trial called ARGX-113-2007. You should be able to understand the study details and give your official consent to participate.
There are also some reasons why you might not be able to join. For example, if you plan to have major surgery during the study, or if you've developed a serious medical condition since the last study that the doctors think would make it risky for you to participate or affect the study results. You also can't take part if you are allergic to the study medicine or any of its ingredients, or if you've developed any new or returning cancer (other than a common type of skin cancer).
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- האם אתה בן 18 או יותר?
- Did you previously take part in the ARGX-113-2007 study?
- Are you able to follow study instructions and give your informed consent?
- Are you not planning to have major surgery during the study?
- Are you not allergic to the study drug or its ingredients?
- Have you not developed any new cancer (other than certain skin cancers)?
מה כרוך בהשתתפות?
If you decide to join this study, you will receive the study medication, efgartigimod, as an injection under your skin regularly for up to 51 months (about 4 years and 3 months). During this time, you will have regular visits to the clinic so doctors can monitor your health and how the medication is affecting you. After you finish taking the medication, there will be a follow-up period of about 8 weeks (56 days) where your health will continue to be checked to ensure your safety. The total duration of your involvement could be up to 53 months, including the treatment and follow-up periods.
סיכונים ותועלות פוטנציאליים
Locations (92)
- Neuromuscular Clinical and Research Center - Neurologyמיקוד מאומתפניקס, ארצות הברית
- Attune Health Research, Incמיקוד מאומתבוורלי הילס, ארצות הברית
- UCI Health - ALS and Neuromuscular Center - Neurologyמיקוד מאומתאורנג', ארצות הברית
- UCSF Health - ALS and Neurodegenerative Disease Center - Dermatologyמיקוד מאומתסן פרנסיסקו, ארצות הברית
- Yale Cancer Center-Yale University School Of Medicineמיקוד מאומתניו הייבן, ארצות הברית
- UF Health - Rheumatology Medical Specialties Medical Plazaמיקוד מאומתגיינסוויל, ארצות הברית
- Mayo Clinic - Florida - Neurologyמיקוד מאומתג'קסונוויל, ארצות הברית
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)מיקוד מאומתטמפה, ארצות הברית
- Emory Healthcare - Emory Clinic - Rheumatologyמיקוד מאומתאטלנטה, ארצות הברית
- Northwestern Medicine - Northwestern Memorial Hospitalמיקוד מאומתשיקגו, ארצות הברית
- John Hopkins Medicine - Johns Hopkins Myositis Centerמיקוד מאומתבולטימור, ארצות הברית
- Northwell Health Physician Partners Rheumatologyמיקוד מאומתGreat Neck, United States
שאלות נפוצות
What is efgartigimod?
Efgartigimod is the name of the study medication being tested for treating certain muscle conditions.
What medical conditions are being studied?
The study focuses on adult patients with specific muscle conditions, such as myositis, dermatomyositis, and polymyositis.
כיצד ניתן ללמוד רפואה?
The study medicine is given as an injection under the skin.
כמה זמן אהיה במחקר?
You could be in the study for up to 51 months receiving the treatment, plus a two-month follow-up period, making the total up to roughly 4 and a half years.
האם אני יכול לעזוב את המחקר בכל עת?
Yes, you are free to leave the study at any point without having to give a reason and without your medical care being affected.
כיצד לגלות עוד
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
מעוניינים להשתתף?
דיון
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