RecruitingPHASE4INTERVENTIONAL

ToFAcitinib in Early Active Axial SpondyloarThritis:

This research is looking into a new medicine called tofacitinib for people who have early and active axial spondyloarthritis, a type of arthritis that mainly affects the spine. The study wants to find out how well tofacitinib works compared to a placebo (a dummy pill) and if it is safe. Participants will take tofacitinib or the placebo for 16 weeks, alongside their regular anti-inflammatory (NSAID) medication. We're looking for people whose current anti-inflammatory medicine isn't fully controlling their symptoms, and who also show signs of inflammation in MRI scans or blood tests. The study is for adults aged 18 to 45.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Charite University, Berlin, Germany

Enrolment target

104

Start

10 Nov 2023

Estimated completion

01 Jun 2026

Axial Spondyloarthritis

What is this study about?

This study is investigating a medication called tofacitinib for a condition known as axial spondyloarthritis (often shortened to axSpA). This condition causes ongoing pain and stiffness, mainly in the spine, and can significantly impact daily life. We're particularly interested in people who have had symptoms for a shorter time and whose condition is still active, meaning it's causing noticeable discomfort and inflammation.

The main goal is to see if tofacitinib can help reduce the symptoms of axSpA and improve quality of life for these patients. It's being compared to a 'placebo', which looks exactly like the study drug but contains no active medicine. This comparison is vital to truly understand the effects of tofacitinib. All participants will also continue taking their usual anti-inflammatory (NSAID) medication, as prescribed by their doctor.

Understanding how new treatments work and if they are safe is a big part of medical progress. This research is important because it could offer another option for managing axSpA, potentially giving people more relief from their symptoms and helping them live more comfortably. By taking part, you're contributing to medical knowledge that could benefit many others in the future.

Key takeaways

This study tests a new drug for early, active axial spondyloarthritis.
It compares tofacitinib to a dummy pill (placebo) over 16 weeks.
Participants will also continue their regular anti-inflammatory medicine.
The study includes visits, blood tests, and possibly MRI scans.
Close medical monitoring is provided throughout the 20-week study period.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, we're looking for people who have been diagnosed with axial spondyloarthritis. Your back pain or other symptoms related to the condition should have started fairly recently, within the last two years. Also, your condition needs to be 'active,' meaning you're experiencing ongoing symptoms like significant back pain and your doctor has noted signs of inflammation, either from an MRI scan of your lower spine or from blood tests showing high inflammatory markers.

There are also some reasons why you might not be able to join. For example, if you currently have an active infection or have had a serious infection recently. Certain other health conditions, such as problems with your immune system, chronic hepatitis B or C, or HIV, would also mean you couldn't participate. For women, you cannot be pregnant or breastfeeding, and you would need to use reliable contraception throughout the study.

We also can't include people with other serious health problems that might make taking part risky or interfere with the study results. There might also be reasons related to MRI scans that could prevent participation. The study is specifically for adults between the ages of 18 and 45. Your study doctor will go through all these details with you carefully.

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.

Have I been diagnosed with axial spondyloarthritis?
Have my symptoms (like back pain) started within the last two years?
Do I currently have active symptoms AND signs of inflammation on an MRI or blood test?
Am I between 18 and 45 years old?
Am I free from serious infections or certain other major health conditions?
If I am a woman, am I not pregnant or breastfeeding, and can I use reliable contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned by chance to either receive the study medication (tofacitinib) or a dummy pill (placebo). You won't know which one you're taking, and neither will your study doctor – this is common practice in research to ensure fair results. You will continue to take your usual anti-inflammatory (NSAID) medicine throughout the study. The treatment period for the study medication will be 16 weeks, which is about 4 months.

During these 16 weeks, you will have several scheduled visits to the clinic for assessments. These will include check-ups with the doctor, blood tests, and possibly follow-up MRI scans to monitor your condition and how you are responding to the treatment. These visits help us understand if the medication is working and if you are tolerating it well. After the 16-week treatment period, there will be an additional 4 weeks of safety follow-up, during which you will still be monitored to ensure your well-being. The total duration of your participation in the study, including treatment and follow-up, will be around 20 weeks.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. A potential benefit of joining this study is that you might receive an active drug, tofacitinib, which could help improve your axial spondyloarthritis symptoms. You will also receive very close medical monitoring from the study team. However, there's also a chance you could receive the placebo, which has no active medicine. Potential risks of any new medication can include side effects; the study team will fully explain known side effects of tofacitinib. We also can't predict all potential effects. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Charité Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is axial spondyloarthritis?

It's a type of arthritis that mainly causes long-term pain and stiffness in the spine, but can sometimes affect other joints and parts of the body.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers fairly compare the new medicine's effects.

Why can't I be pregnant or breastfeeding?

Because we don't know the effects of the study drug on unborn babies or infants, women who are pregnant or breastfeeding cannot participate to ensure their safety.

Will I have to stop my current medicines?

No, you will continue taking your usual anti-inflammatory (NSAID) medication throughout the study. Other medicines will be discussed with your study doctor.

How long will I be in the study?

Your participation will last for a total of about 20 weeks, which includes 16 weeks of taking the study medicine (or placebo) and 4 weeks of safety follow-up.

How to find out more

Hildrun Haibel, PD Dr. med.

hildrun.haibel@charite.de +49308445 Official trial record

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