A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
This research study is investigating an experimental drug named Nipocalimab for adults who have idiopathic inflammatory myopathies (IIM), also known as myositis. These conditions cause muscle weakness and inflammation. The main goal is to find out if Nipocalimab is effective and safe compared to a placebo (a dummy treatment). Participants will also be receiving standard treatments like glucocorticoids. By comparing the new drug to a placebo, researchers hope to understand if Nipocalimab could be a helpful new option for managing the symptoms of active IIM. It's a 'Phase 2' study, meaning it's still in the earlier stages of testing.
एक नजर में
यह अध्ययन किस बारे में है?
This study is designed to explore a new treatment called Nipocalimab for people who have a group of conditions known as idiopathic inflammatory myopathies (IIMs), or myositis. These are conditions where your body's immune system mistakenly attacks your muscles (and sometimes other parts of the body), leading to weakness, pain, and inflammation. The aim is to see if Nipocalimab can help improve symptoms and is safe to use in people whose condition is currently active.
You might be wondering what Nipocalimab is. It's an experimental drug, which means it's still being tested and isn't yet available as a standard treatment. In this study, some people will receive Nipocalimab, while others will receive a placebo – which looks exactly like the study drug but contains no active medicine. This is a common way to accurately test if a new drug works better than no treatment at all. All participants will also continue with their usual care, which may include steroid medications (glucocorticoids).
This is a 'Phase 2' study. This means it's an important step in developing new medicines. Researchers are looking for early signs of how well the drug works and checking its safety in a larger group of people than in a Phase 1 study. The findings from this study will help decide if Nipocalimab should be studied further in even larger trials.
मुख्य निष्कर्ष
- This study is for adults with active inflammatory myopathies (myositis).
- It's testing a new medication called Nipocalimab against a dummy treatment (placebo).
- You'll continue your existing steroid medications (glucocorticoids) if prescribed.
- The study involves regular clinic visits for assessments and monitoring.
- Your myositis diagnosis will be confirmed using specific criteria, including blood antibody tests.
कौन पात्र हो सकता है?
To join this study, you must be an adult aged 18 or over. You need to have been diagnosed with an idiopathic inflammatory myopathy (IIM), or myositis, for at least six weeks before the study starts, and your condition must be active. Doctors will use specific guidelines to confirm your diagnosis.
An important part of eligibility is having certain 'myositis-specific' antibodies in your blood. These antibodies help doctors understand the specific type of myositis you have. You'll have blood tests to check for these antibodies. If you're using certain skin creams for your condition, such as mild steroid creams or tacrolimus, the dose needs to have been stable for at least four weeks before starting the study and kept the same throughout most of the study.
There are also reasons why you might not be able to join. For example, if you were diagnosed with myositis when you were a child and are now an adult, you wouldn't be eligible. Also, if you have myositis linked to cancer, you wouldn't be able to take part in this particular study.
क्या यह अध्ययन आपके लिए उपयुक्त हो सकता है?
यह देखने के लिए इन त्वरित प्रश्नों का उत्तर दें कि क्या आप पात्र हो सकते हैं। यह केवल एक मार्गदर्शिका है — अंतिम निर्णय शोध टीम द्वारा लिया जाता है।.
- क्या आप 18 वर्ष या उससे अधिक आयु के हैं?
- Have you been diagnosed with inflammatory myopathy (myositis) for at least six weeks, and is your condition currently active?
- Have your doctors identified specific 'myositis-specific' antibodies in your blood?
- If you use skin creams for myositis, has the dose been stable for at least four weeks?
- Have you *not* been diagnosed with juvenile myositis (myositis diagnosed in childhood)?
भागीदारी में क्या शामिल है?
The study involves several visits to the clinic over a period of time. You will be assigned to either receive the study drug (Nipocalimab) or a placebo, and you won't know which one you're getting. You'll also continue to receive any steroid medications (glucocorticoids) your doctor has prescribed for your condition. During your visits, the research team will perform various assessments, including blood tests, physical examinations, and asking you questions about how you're feeling and how your symptoms are changing. These assessments help the researchers understand how the study drug affects your condition and to monitor your health. The total duration of your participation in the study, including follow-up, will be determined by the study design, potentially up to 52 weeks.
संभावित जोखिम और लाभ
Locations (57)
- Arizona Arthritis and Rheumatology Research PLLCसत्यापित पोस्टकोडफीनिक्स, संयुक्त राज्य अमेरिका
- HonorHealth Neurologyसत्यापित पोस्टकोडस्कॉट्सडेल, संयुक्त राज्य अमेरिका
- Attune Health Autoimmune and Inflamation Care and Researchसत्यापित पोस्टकोडबेवर्ली हिल्स, संयुक्त राज्य अमेरिका
- कैलिफोर्निया विश्वविद्यालय इरविन मेडिकल सेंटरसत्यापित पोस्टकोडऑरेंज, संयुक्त राज्य अमेरिका
- हार्बर-यूसीएलए मेडिकल सेंटर में बायोमेडिकल इनोवेशन के लिए लुंडक्विस्ट संस्थानसत्यापित पोस्टकोडटोरेंस, संयुक्त राज्य अमेरिका
- FM Clinical Research, LLC South Florida Neurology Associates, P. A.सत्यापित पोस्टकोडबोका रैटन, संयुक्त राज्य अमेरिका
- Integral Rheumatology And Immunology Specialistsसत्यापित पोस्टकोडप्लांटेशन, संयुक्त राज्य अमेरिका
- University of South Floridaसत्यापित पोस्टकोडटाम्पा, संयुक्त राज्य अमेरिका
- Augusta Universityसत्यापित पोस्टकोडऑगस्टा, संयुक्त राज्य अमेरिका
- कैनसस विश्वविद्यालय चिकित्सा केंद्रसत्यापित पोस्टकोडकैनसस सिटी, संयुक्त राज्य अमेरिका
- जॉन्स हॉपकिन्स विश्वविद्यालयसत्यापित पोस्टकोडबाल्टीमोर, संयुक्त राज्य अमेरिका
- The Brigham and Women's Hospital, Inc.सत्यापित पोस्टकोडबोस्टन, संयुक्त राज्य अमेरिका
सामान्य प्रश्न
What is myositis?
Myositis is a group of conditions where your body's immune system mistakenly attacks your muscles, causing weakness and inflammation.
What is Nipocalimab?
Nipocalimab is an experimental medication being tested to see if it can help people with inflammatory myopathies. It's not yet available as a standard treatment.
प्लेसबो क्या है?
A placebo is a 'dummy' treatment that looks just like the real study drug but contains no active medicine. It helps researchers compare the effects of the new drug.
Will I still take my regular medicines?
Yes, you will continue with your usual treatments for myositis, such as steroid medications, alongside the study drug or placebo.
अगर मैं अपना मन बदल लूँ तो क्या मैं अध्ययन छोड़ सकता हूँ?
Absolutely. You are free to withdraw from the study at any time, for any reason, without it affecting your regular medical care.
और अधिक जानने के लिए कैसे पता करें
किसी अध्ययन में भाग लेने का निर्णय लेने से पहले हमेशा अपने जीपी या विशेषज्ञ से बात करें।.
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