Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
This research study is looking at the long-term safety and how well a new medication called cenerimod works for adults who have moderate to severe systemic lupus erythematosus, a condition where the body's immune system attacks its own tissues. Participants in this study have already taken part in a previous one where they either received cenerimod or a dummy pill for one year. The main goals are to see if cenerimod causes any side effects when added to existing lupus treatments and how effectively it helps reduce lupus symptoms over one to three years. Around 680 people will receive cenerimod during this study, in addition to their current medications, for up to three years. The study wants to understand if the positive effects seen in earlier trials continue over a longer period.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is designed to help us understand more about a new medication called cenerimod for Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term condition where your body's immune system mistakenly attacks healthy cells and tissues, leading to inflammation and damage in various parts of the body. Cenerimod is being investigated as a potential new treatment to help manage the symptoms of lupus.
You might be interested in this study if you've already participated in one of the earlier trials for cenerimod (named ID-064A301 or ID-064A302). If you were in one of those studies for a year, this extension study is a chance to continue receiving the active medication, cenerimod. The main purpose is to see if cenerimod is safe and well-tolerated when used for a longer time – up to three years – and how well it continues to help with lupus symptoms when taken alongside your other usual lupus medicines.
By taking part, you would be helping researchers learn valuable information about cenerimod. This will help doctors understand its effects over a longer period, which is really important for developing new treatments. The information gathered from this study could eventually help many others living with lupus in the future.
النقاط الرئيسية
- Study examines the long-term safety and effectiveness of cenerimod for lupus.
- Only for adults (18-75) who completed a previous cenerimod study.
- All participants receive cenerimod for up to three years, alongside usual lupus medicines.
- Regular clinic visits and health monitoring are part of participation.
- Contribution helps develop new long-term treatments for lupus.
- يمكنك التوقف عن المشاركة في أي وقت.
من قد يكون مؤهلاً؟
To join this study, you must have previously completed a full 12 months in one of the earlier cenerimod studies (either ID-064A301 or ID-064A302) and still have a diagnosis of systemic lupus erythematosus. You must also have followed the rules of that previous study well and completed all your visits.
There are also some reasons why you might not be able to join. For example, if your kidney lupus is very severe or your lupus is significantly affecting your brain, and your doctor thinks you need different or stronger treatments than those allowed in the study, you may not be eligible. Also, if you are a woman who could get pregnant, you must agree to take monthly pregnancy tests and use very effective contraception throughout the study and for six months after your last dose of medication. If you are planning to become pregnant during this time, you cannot join.
The study is open to adults between 18 and 75 years old, and anyone of any gender can participate. Your study doctor will review all the criteria carefully to ensure this study is right 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.
- Have I already completed a full year in the cenerimod studies ID-064A301 or ID-064A302?
- Do I still have a diagnosis of systemic lupus erythematosus?
- Am I between 18 and 75 years old?
- If I am a woman who could get pregnant, am I willing to use effective contraception and have monthly pregnancy tests?
- Do I have any severe kidney or brain-related lupus that my doctor feels needs different treatments than those allowed in the study?
ماذا يتضمن المشاركة؟
If you join this study, you will receive cenerimod 4 mg once a day, in addition to your usual lupus medications (which might include steroids, anti-malarial drugs, or immunosuppressants). All participants in this study will receive the active medication, cenerimod; there won't be a dummy pill (placebo) in this part of the study.
You will take cenerimod for at least one year and potentially up to three years. Your total time in the study, including follow-up, could be up to three and a half years. During this period, you will have regular visits to the clinic so the research team can monitor your health, check for any side effects, and see how your lupus symptoms are responding. After your last dose of cenerimod, there will be a follow-up period of six months with a final study visit to ensure everything is well.
المخاطر والفوائد المحتملة
المواقع (106)
- Clinical Research of West Florida, Inc.الرمز البريدي المؤكدكليرووتر، الولايات المتحدة
- Omega Research MetroWest, LLCالرمز البريدي المؤكدDeBary, United States
- SouthCoast Research Center, Inc.الرمز البريدي المؤكدميامي، 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 Res Clin Inc.الرمز البريدي المؤكدميامي ليكس، الولايات المتحدة
- Accurate Clinical Research Inc. - Lake Charlesالرمز البريدي المؤكدLake Charles, United States
- RB Wellness Clinicالرمز البريدي المؤكدلاس فيغاس، الولايات المتحدة
- Accurate Clinical Research Inc - (Najam)الرمز البريدي المؤكدBaytown, United States
- Novel Research LLCالرمز البريدي المؤكدبيلاير، الولايات المتحدة
- Accurate Clinical Research Inc.الرمز البريدي المؤكدهيوستن، الولايات المتحدة
أسئلة شائعة
What is systemic lupus erythematosus (lupus)?
Lupus is a chronic autoimmune disease where your body's immune system attacks its own healthy tissues, causing inflammation and damage.
What is cenerimod?
Cenerimod is an experimental medication being studied for its potential to treat lupus by affecting how your immune system works.
Will I receive a dummy pill in this study?
No, in this particular study, all participants will receive the active medication, cenerimod, along with their usual lupus treatments.
كم من الوقت سأكون في الدراسة؟
You'll take cenerimod for at least one year and up to three years. With follow-up, your total participation could be up to three and a half years.
هل يمكنني التوقف عن المشاركة في الدراسة إذا أردت؟
نعم، يمكنك اختيار الانسحاب من الدراسة في أي وقت ولأي سبب، ولن يؤثر ذلك على رعايتك الطبية المعتادة.
كيفية معرفة المزيد
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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