A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
This research study, called START SYNERGY, is looking for people in the UK with active rheumatoid arthritis. Participants in this study are already taking methotrexate and another common arthritis drug, but their symptoms are not fully controlled. The study aims to test a new medicine, ELV001, to see if it can improve their condition. It's a 'Phase 2' study, which means we're still in the earlier stages of understanding how well the drug works and checking its safety. Some people will receive ELV001, while others will get a placebo (a dummy pill with no medicine). We will compare how well both groups do to understand the effects of ELV001.
At a glance
What is this study about?
This study is designed for people living with rheumatoid arthritis, a condition where the body's immune system attacks its own joints, causing pain, swelling, and stiffness. Many people manage their rheumatoid arthritis with medicines like methotrexate and a type of drug called a 'Tumor Necrosis Factor Inhibitor'. However, for some, these treatments don't fully control their symptoms.
This is where a new medicine called ELV001 comes in. This study wants to find out if adding ELV001 to your current treatment can help reduce your arthritis symptoms more effectively. We will also be carefully monitoring for any side effects to make sure ELV001 is safe to use.
This type of study is called a 'Phase 2' trial. This means we're still in the process of learning about this new medicine. We'll be comparing ELV001 to a 'placebo' – a pill that looks exactly like the study medicine but contains no active drug. This helps us understand if any improvements are genuinely due to ELV001 or if they might happen anyway.
Key takeaways
- This study is testing a new medicine (ELV001) for rheumatoid arthritis.
- It's for people whose arthritis isn't fully controlled by their current treatments.
- Participants will receive either ELV001 or a placebo (dummy pill).
- The study will check how well ELV001 works and if it's safe.
- It involves regular clinic visits for checks, blood tests, and questionnaires.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate.
Crucially, you must have active rheumatoid arthritis, meaning your joints are still painful, swollen, or stiff, even though you are already taking methotrexate and a TNF inhibitor drug. The research team will do some checks to make sure your arthritis meets the study's specific criteria.
You'll also need to be well enough generally to take part in the study and commit to the study visits and procedures.
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?
- Do you have active rheumatoid arthritis?
- Are you currently taking methotrexate and a TNF inhibitor drug for your arthritis?
- Are you able to attend regular clinic appointments?
- Are you generally well enough to take part in medical tests?
What does participation involve?
If you decide to join this study, you'll be randomly assigned to either receive the new medicine (ELV001) or a placebo. Neither you nor your study doctor will know which you are receiving, which helps make the results fair.
You will continue to take your regular methotrexate and TNF inhibitor drugs throughout the study. Over a period of 12 to 24 weeks, you'll have regular visits to the clinic. At these visits, doctors will check your joints, take blood and urine samples, measure your vital signs (like blood pressure and heart rate), and perform ECGs (heart tracings). You’ll also answer questionnaires about your pain, daily activities, and general health. The main aim is to see how your arthritis symptoms change over these weeks. There will also be a period where your blood will be checked to understand how your body handles the medicine.
Potential risks and benefits
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Common questions
What is rheumatoid arthritis?
Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks its own joints, leading to pain, swelling, and stiffness.
What is a 'placebo'?
A placebo is a pill that looks just like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine's effects.
Why is this study 'double-blind'?
Being 'double-blind' means neither you nor your study doctor knows if you're getting the new medicine or the placebo. This helps prevent bias and ensures the results are as accurate as possible.
What does 'Phase 2' mean for a medicine?
Phase 2 studies are early-stage trials that involve a larger number of patients than Phase 1. They focus on finding the right dose, checking if the medicine works, and continuing to monitor safety.
Will I get to keep taking the study medicine if it works for me?
This study only lasts for a set period. What happens after the study ends for individual participants would be discussed with you by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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