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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

J3P-MC-FTAF: An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis

This research study is looking at a new potential medicine called LY3871801 for adults who have rheumatoid arthritis that is moderately to severely active. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. This study is split into two main parts. In the first part, we'll be carefully checking how well the new medicine helps to reduce symptoms and disease activity. In the second part, we'll be looking at how many people feel significantly better after taking the medicine, compared to those who receive a 'dummy' pill (placebo). This is a 'double-blind' study, meaning neither you nor your doctor will know if you're getting the new medicine or the dummy pill. This helps us get the most accurate results.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Eli Lilly & Co.
Enrolment target
62
Start
08 Aug 2023

What is this study about?

Rheumatoid arthritis is a condition where your body's immune system, which normally fights off infections, mistakenly attacks the lining of your joints. This can lead to pain, swelling, and stiffness, making everyday tasks difficult. Current treatments can help, but there's always a need for new options that might work better or have fewer side effects for some people.

This study, called J3P-MC-FTAF, is designed to test a new medicine named LY3871801. It's an important step in developing new treatments. The study is in what we call 'Phase 2a/2b', which means we're still in the relatively early stages of understanding how well this medicine works and making sure it's safe. We’re comparing it to a placebo, which looks exactly like the study medicine but contains no active drug. This helps us to see if any improvements are genuinely due to the new medicine or if they could have happened anyway.

The main goals are to see if LY3871801 can reduce the signs of inflammation and disease activity in people with rheumatoid arthritis, and to find out how many participants experience a significant improvement in their well-being and symptoms. Every step of this research is carefully planned and monitored to ensure the safety and well-being of everyone taking part.

Key takeaways

  • This study is testing a new medicine for rheumatoid arthritis.
  • It's for adults with moderately to severely active rheumatoid arthritis.
  • Participants will receive either the new medicine or a dummy pill.
  • The study aims to see if the new medicine is safe and effective.
  • Regular clinic visits and health checks will be part of taking part.
  • You can stop participating in the study at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older. There isn't an upper age limit mentioned, meaning older adults are also welcome to be considered.

The study is open to both men and women. The most important requirement is that you have been diagnosed with rheumatoid arthritis, and your condition is currently active, meaning you are experiencing noticeable symptoms that are moderate to severe.

There will be other, more detailed health checks and requirements that your study doctor will discuss with you. These are in place to make sure the study is safe for you and that the results are reliable. It’s important to talk openly with the study team about your full medical history.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with rheumatoid arthritis?
  3. Is your rheumatoid arthritis currently active (causing noticeable symptoms)?
  4. Are you able to attend regular clinic appointments?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new study medicine, LY3871801, or a placebo (a dummy pill that looks the same but has no active drug). You would take this medication as instructed by the study team. Both you and your doctor would not know whether you're receiving the active medicine or the placebo – this is called a 'double-blind' study and it helps ensure fair and accurate results.

Throughout the study, you would have regular visits to the clinic. These visits would involve various assessments such as blood tests, physical examinations, and questionnaires about your symptoms and how you are feeling. These tests help the researchers understand how the medicine is affecting your body and your rheumatoid arthritis. The study will last for a certain period, and you would be given a detailed schedule of all your appointments and what to expect at each one. There will also be follow-up appointments after you finish taking the study medicine to ensure your well-being.

Potential risks and benefits

Taking part in any research study involves potential benefits and risks. You might find that the new medicine helps your rheumatoid arthritis symptoms. However, it's also possible you could experience side effects, or that the medicine might not improve your condition. The study team will explain all known risks to you, and your safety will be carefully monitored throughout. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France
  • Unverified
    Czechia
  • Unverified
    Slovakia
  • Unverified
    Germany
  • Unverified
    Hungary
  • Unverified
    Poland

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks your own joints, causing pain, swelling, and stiffness.

What does 'double-blind' mean in a study?

It means neither you nor your doctor will know if you're receiving the new medicine or a dummy pill. This helps ensure unbiased results.

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks exactly like the study medicine but doesn't contain any active drug.

Will I have to pay to join the study?

No, you will not have to pay to take part in the study. All study-related medication and assessments are provided free of charge.

What happens after the study ends?

After the study ends, the research team will explain the results, and you'll return to your usual medical care with your regular doctor.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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