A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
This research study is for adults with psoriatic arthritis, a condition that causes joint pain and swelling, and can also affect the skin. Participants in this study have already tried other common treatments (called anti-TNF medicines) that haven't worked well enough for them. The study is testing a new medicine called tildrakizumab, also known as Ilumetri. It's a 'Phase III' study, which means it's a large, important trial designed to confirm if tildrakizumab is both safe and effective. Some people will receive the new medicine, while others will get a 'placebo' – a dummy medicine that looks the same but contains no active drug. This helps researchers compare the effects accurately. The main goal is to see if tildrakizumab can significantly improve symptoms like joint pain and swelling after 24 weeks.
At a glance
What is this study about?
This study is looking into a new treatment for psoriatic arthritis. Psoriatic arthritis is a type of arthritis that can cause pain, stiffness, and swelling in the joints, and it sometimes happens in people who also have psoriasis, a skin condition. While there are treatments available, they don’t work for everyone.
This specific study is for people who have already tried a type of medicine called 'anti-TNF' treatments, but these haven't helped their psoriatic arthritis enough. The study is testing a medicine called tildrakizumab, which is also known as Ilumetri. Researchers want to see if this new medicine can reduce the joint pain and swelling caused by psoriatic arthritis, and if it's safe to use.
To make sure the results are fair and accurate, some people in the study will receive tildrakizumab, and others will receive a 'placebo' – this is a dummy injection that looks exactly like the real medicine but contains no active drug. Neither the participants nor their doctors will know who is getting which, to avoid any bias. This is a common and important way to test new medicines effectively.
Key takeaways
- This study tests a new medicine (tildrakizumab) for psoriatic arthritis.
- It's for adults whose psoriatic arthritis hasn't improved with other treatments.
- Some participants will get the new medicine, others a dummy medicine (placebo).
- The main aim is to see if it reduces joint pain and swelling.
- Participation involves regular clinic visits and injections.
- You can stop taking part at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
Crucially, you must have active psoriatic arthritis, meaning your joints are currently inflamed and painful. You also need to have tried certain other treatments, specifically a type of medicine called 'anti-TNF' drugs, and found that they didn't work well enough for your condition.
There will be other detailed health checks to make sure the study is a good fit for you and that you can take the medication safely. These will be discussed with you by the study team.
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 psoriatic arthritis?
- Have you tried anti-TNF medicines for your psoriatic arthritis that didn't work well enough?
- Are you able to attend regular clinic appointments?
- Are you willing to receive injections as part of the treatment?
What does participation involve?
If you decide to take part in this study, you would receive either the study medicine (tildrakizumab) or a placebo (dummy medicine) through injections, given in a pre-filled syringe. You'll have regular appointments at the clinic for health checks, blood tests, and to assess how your psoriatic arthritis symptoms are changing. These appointments would track your progress over a period of time, likely several months, and the study team will explain the exact schedule. You would also have follow-up visits after the main treatment period to ensure your continued well-being. The total duration of your involvement, including follow-up, would be made clear to you before you agree to participate.
Potential risks and benefits
Locations (7)
- —UnverifiedCzechia
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- —UnverifiedEstonia
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- —UnverifiedSlovakia
- —UnverifiedItaly
- —UnverifiedPoland
Common questions
What is psoriatic arthritis?
Psoriatic arthritis is a type of arthritis that causes painful, stiff, and swollen joints. It's often linked to psoriasis, a skin condition.
What does 'Phase III' mean?
Phase III means it's a large study designed to confirm if a new medicine is safe and effective before it can be made widely available.
What is a 'placebo'?
A placebo is a dummy medicine that looks just like the real drug but contains no active ingredients. It helps researchers compare the effects accurately.
What are 'anti-TNF' medicines?
Anti-TNF medicines are a type of treatment commonly used for inflammatory conditions like psoriatic arthritis. This study is for people who haven't responded well to them.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your doctor will know during the study. This is called 'double-blind' and helps ensure fair and unbiased results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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