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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A stratification trial to determine key immunological factors predicting Tofacitinib efficacy in Psoriatic Arthritis (PsA); TOFA-PREDICT

The TOFA-PREDICT study is investigating a medicine called Tofacitinib, which is used to treat Psoriatic Arthritis (PsA). Psoriatic Arthritis is a condition that causes swollen, painful joints and can also affect the skin. Researchers want to find out why this medicine works well for some people but not for others. They will be looking closely at information from participants' bodies before they start treatment and during their first 16 weeks on Tofacitinib. The aim is to identify specific patterns in their body's chemistry that might predict how well the medicine will work. This could help doctors choose the best treatment for each person with PsA in the future, making treatment more effective.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Universitair Medisch Centrum Utrecht
Enrolment target
160
Start
24 Jun 2024

What is this study about?

The TOFA-PREDICT study focuses on understanding how a medicine called Tofacitinib works for people living with Psoriatic Arthritis (PsA). PsA is a type of arthritis linked to psoriasis, causing joint pain, stiffness, and swelling. Tofacitinib is a tablet medicine that helps calm down the immune system, reducing inflammation in the joints and skin. We know that medicines like Tofacitinib don't work the same way for everyone – some people respond very well, while others might not see as much improvement.

The main goal of this study is to find out if there are specific signals in a person's body before they start treatment that can predict how well Tofacitinib will work for them. Researchers will be looking at what they call 'molecular network profiles'. This is like taking a detailed snapshot of your body's internal chemistry. By comparing these snapshots from before treatment with how you feel after 16 weeks on the medicine, the doctors hope to identify patterns. For example, they might discover certain markers that indicate someone is more likely to benefit from Tofacitinib.

This research is important because it could help doctors make more informed decisions about which treatments to prescribe for people with PsA. If they can predict who will respond best to Tofacitinib, they can choose the most effective medicine from the start, saving time and reducing discomfort for patients. It's about personalising treatment so that each person gets the best possible care for their specific needs.

Key takeaways

  • This study investigates Tofacitinib for Psoriatic Arthritis.
  • It aims to predict who will respond best to the medicine using body chemistry analysis.
  • Participation involves taking medication and attending clinic visits for 16 weeks.
  • You could receive Tofacitinib or other standard PsA treatments.
  • Your involvement could help personalise treatment for future PsA patients.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. There is no upper age limit for participation.

To be considered for this study, you must have a diagnosis of Psoriatic Arthritis. The study doctors will carefully check a range of health information to make sure joining is safe and appropriate for you.

It's important to remember that this is a research study, and not everyone with Psoriatic Arthritis will be able to take part. The research team will review your medical history to ensure you meet all the specific requirements necessary 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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of Psoriatic Arthritis?
  3. Are you able to attend regular clinic appointments for about 16 weeks?
  4. Are you willing to have blood tests and other health checks?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Tofacitinib, or other standard treatments for Psoriatic Arthritis like Methotrexate or Enbrel, as determined by your doctor within the study's guidelines. You would typically take Tofacitinib tablets daily. The study would involve several visits to the clinic over a period of 16 weeks. During these visits, the research team would assess how you are feeling, check your joints, and perform blood tests. These tests help them understand how your body is responding to the treatment and look for changes in your body's chemistry. You would also be asked about your overall quality of life. After the 16-week period, there would likely be follow-up assessments to monitor your progress. The total duration of your active participation, including assessments, would be around 16 weeks.

Potential risks and benefits

Participating in this study might offer you access to a well-known treatment for Psoriatic Arthritis, Tofacitinib, and contribute to important medical knowledge that could help others in the future. However, there are potential risks, as with any medication, including side effects which your doctor would discuss with you. You might also need to attend more hospital visits than usual. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Netherlands

Common questions

What is Psoriatic Arthritis?

Psoriatic Arthritis is a type of long-term arthritis that affects some people who have the skin condition psoriasis. It causes pain, stiffness, and swelling in and around the joints.

What is Tofacitinib?

Tofacitinib (also known by its brand name XELJANZ) is a tablet medicine used to treat conditions like Psoriatic Arthritis. It works by calming down parts of your immune system that cause inflammation.

Why is this study being done?

The study aims to understand why Tofacitinib works well for some people with Psoriatic Arthritis but not others, by looking at their body's internal chemistry. This could help doctors choose the best treatment for each patient in the future.

Will I definitely get Tofacitinib if I join?

You will receive either Tofacitinib or other standard treatments for Psoriatic Arthritis, such as Methotrexate or Enbrel, as decided by the study doctors based on the study's plan.

How long will I be in the study?

The main part of your participation, including receiving treatment and assessments, would last about 16 weeks.

How to find out more

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

Discussion

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