Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome; RepurpSS-II study
The RepurpSS-II study is a clinical trial exploring whether a combination of two medicines, Leflunomide and Hydroxychloroquine, can effectively treat primary Sjögren's Syndrome. This condition causes the body's immune system to mistakenly attack its own moisture-producing glands, leading to dryness, pain, and fatigue. This Phase II study aims to compare the effects of these combined drugs against a placebo (a dummy pill). The main goal is to see if the drug combination can reduce the overall activity of the disease over 24 weeks. Researchers will also look at whether it helps with key symptoms like dry eyes and mouth, and joint pain, to understand if this treatment could offer a new option for patients.
At a glance
What is this study about?
This study, called RepurpSS-II, is investigating a new way to treat primary Sjögren's Syndrome. This is a long-term condition where your body's immune system, which normally fights off infections, mistakenly attacks healthy parts of your body. In Sjögren's, it often targets glands that produce moisture, leading to very dry eyes and mouth, and it can also affect other areas like joints and organs. The medicines being tested are Leflunomide and Hydroxychloroquine. Both are already used for other immune-related conditions, but this study asks if using them together could be helpful for Sjögren's.
The main aim of the study is to see if this combination of drugs can reduce the overall activity of primary Sjögren's Syndrome over a period of 24 weeks, compared to taking a placebo (a dummy pill that looks like the real medicine but contains no active ingredients). This will help doctors understand if these existing drugs, when used together, could offer a new treatment option for people living with this condition.
Beyond measuring overall disease activity, the study will also look at how the combination treatment affects specific symptoms that are very important to patients. This includes changes in how dry someone's eyes and mouth feel, how well tears are produced, and if there's any improvement in joint swelling or tenderness. By looking at all these different aspects, researchers hope to get a full picture of whether this treatment could make a real difference to people's quality of life.
Key takeaways
- Tests existing drugs (Leflunomide and Hydroxychloroquine) for Sjögren's.
- Aims to reduce overall disease activity and improve dryness.
- Compares treatment effects against a placebo (dummy pill).
- Study lasts for 24 weeks with regular check-ups.
- Open to adults aged 18 and over with primary Sjögren's Syndrome.
Who may be eligible?
To be able to take part in this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Since this study is specifically looking at primary Sjögren’s Syndrome, participants would need to have received a diagnosis for this condition. The study would also likely have other health requirements to make sure it's safe for you to take the trial medications and that your health condition won't affect the study results.
It's important to remember that these are just general guidelines. A doctor or research nurse involved in the study would go through a more detailed checklist with you to see if you are a good fit for the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with primary Sjögren's Syndrome?
- Are you able to attend regular clinic visits for 24 weeks?
- Are you willing to take study medication (which might be a placebo)?
- Are you open to discussing your health in detail with the study team?
What does participation involve?
If you decide to take part in this study, you would receive either the combination of Leflunomide and Hydroxychloroquine, or a placebo (a dummy pill). This would be decided at random, meaning you wouldn't get to choose which group you are in. You would take your assigned medication regularly over 24 weeks.
Throughout the study, you would have several visits to the clinic. These visits would involve various assessments to see how you are responding to the treatment. This includes checking your overall disease activity, measuring how much saliva and tears you produce, and answering questionnaires about your symptoms, such as how dry your eyes and mouth feel, or any joint pain.
There might also be blood tests and other examinations to monitor your health and how the medication is affecting you. The total duration of your active involvement in the study, taking the medication and having regular check-ups, would be 24 weeks.
Potential risks and benefits
Locations (1)
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Common questions
What is primary Sjögren's Syndrome?
It's a long-term immune system condition that mainly causes very dry eyes and mouth, as your body mistakenly attacks moisture-producing glands.
What medicines are being tested?
The study is looking at a combination of two existing medicines, Leflunomide and Hydroxychloroquine, that are currently used for other conditions.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medication but contains no active ingredients. It helps researchers compare the real effects of the drug.
How long does the study last?
Active participation in the study, including taking medication and clinic visits, lasts for 24 weeks.
Will I know if I'm getting the real medicine or the placebo?
No, this is usually kept secret from both you and the study team (it's called 'blinded') to ensure the results are fair and unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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