A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
This research study is looking into a new medicine called cenerimod for adults who have moderate to severe Systemic Lupus Erythematosus (SLE), also known simply as lupus. The main goal is to find out how well cenerimod works to improve lupus symptoms when added to the medicines patients are already taking. Researchers also want to check if cenerimod is safe to use. About 420 people will take part, with half receiving cenerimod and the other half receiving a dummy pill (placebo) for 12 months, all while continuing their usual lupus treatment. This will help doctors understand its potential benefits and any side effects.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is about a medicine called cenerimod and its potential to help people with Systemic Lupus Erythematosus (SLE). SLE, often just called lupus, is a long-term condition where the body's immune system mistakenly attacks its own tissues and organs. This can cause a range of symptoms, from joint pain and skin rashes to problems with kidneys and other organs. Currently, there are treatments to manage lupus, but researchers are always looking for new and better options.
Here, doctors want to see if adding cenerimod to the treatment plan that patients are already on can lead to fewer symptoms and better health. They are specifically focusing on adults whose lupus symptoms are moderate to severe. It’s important to find new treatments because lupus can affect people differently, and what works for one person might not work as well for another.
By comparing cenerimod to a 'dummy' pill (placebo), the study aims to clearly show if any improvements are due to cenerimod itself. This type of study helps make sure any new medicine is truly effective and safe before it can be widely used. Your participation could help advance our understanding of lupus and potentially lead to new ways to manage this condition for many others.
النقاط الرئيسية
- The study is for adults with moderate to severe lupus (SLE).
- It tests a new medicine called cenerimod alongside your usual lupus treatment.
- Half of participants will get cenerimod, half a dummy pill (placebo).
- The study will last about 12 months.
- It aims to see if cenerimod is safe and helps reduce lupus symptoms.
من قد يكون مؤهلاً؟
To join this study, you need to be an adult between 18 and 75 years old and have had a diagnosis of Systemic Lupus Erythematosus (SLE) for at least six months. Your lupus symptoms should be active and moderately severe, as judged by specific medical scores.
You also need to be taking certain medicines for your lupus already. These could include anti-malarials (like hydroxychloroquine), mycophenolate mofetil or mycophenolic acid, azathioprine, methotrexate, specific steroid doses (like prednisone), or belimumab. The timing of when you started these medicines is also important.
For women who could become pregnant, you would need to have a negative pregnancy test and agree to use reliable contraception throughout the study and for six months afterwards. The study team will check all these details carefully to make sure it's the right fit for you.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- هل عمرك بين 18 و 75 سنة؟
- Have you been diagnosed with Systemic Lupus Erythematosus (SLE) for at least 6 months?
- Are your lupus symptoms currently active and moderately severe?
- Are you currently taking one of the specified lupus medications (e.g., anti-malarials, specific steroids, belimumab)?
- If you are a woman, could you become pregnant and are you willing to use contraception during the study?
ماذا يتضمن المشاركة؟
If you join this study, you will be in it for about 12 months. Throughout this time, you'll continue taking your usual lupus medicines. In addition, you'll either receive the study medicine, cenerimod, or a placebo (a dummy pill that looks like the active medicine but contains no active drug). You won't know which one you're receiving, and neither will your study doctor, to ensure fair results. You'll need to attend regular clinic visits for check-ups, assessments of your lupus symptoms, and to have blood or urine tests. These visits help the research team keep track of your health, how your lupus is doing, and if the study medicine is having any effects.
المخاطر والفوائد المحتملة
Locations (147)
- Tucson Clinical Research Institute, LLCالرمز البريدي المؤكدتوسان، الولايات المتحدة
- UCSD Perlman Medical Officesالرمز البريدي المؤكدلا جولا، الولايات المتحدة
- مركز أبحاث أميكيسالرمز البريدي المؤكدنورثريدج، الولايات المتحدة
- Hope Clinical Trials, Inc.الرمز البريدي المؤكدكورال غيبلز، الولايات المتحدة
- Vital Pharma Researchالرمز البريدي المؤكدهياليه، الولايات المتحدة
- Tectum Medical Researchالرمز البريدي المؤكدهوليوود، الولايات المتحدة
- Alloy Clinical Research, LLCالرمز البريدي المؤكدكيسيمي، الولايات المتحدة
- Allied Biomedical Research Instituteالرمز البريدي المؤكدميامي، الولايات المتحدة
- D&H National Research Centers INCالرمز البريدي المؤكدميامي، الولايات المتحدة
- Professional research Center INCالرمز البريدي المؤكدميامي، الولايات المتحدة
- San Marcus Research Clinic, Inc.الرمز البريدي المؤكدميامي ليكس، الولايات المتحدة
- Tandem Clinical Researchالرمز البريدي المؤكدMarrero, United States
أسئلة شائعة
What is Systemic Lupus Erythematosus (SLE)?
SLE is a long-term illness where your body's immune system attacks its own tissues, causing problems in many parts of the body.
What is cenerimod?
Cenerimod is a new medicine being tested to see if it helps reduce lupus symptoms.
ما هو الدواء الوهمي؟
A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.
كم ستستغرق مدة الدراسة؟
If you join, you will be part of the study for about 12 months.
هل يمكنني التوقف عن المشاركة في الدراسة إذا غيرت رأيي؟
Yes, you can leave the study at any time, for any reason, without affecting your medical care.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
نقاش
مناقشة المجتمع
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