Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Tofacitinib in early active axial spondyloarthritis: a prospective, randomized, double-blind, placebo-controlled multicentre study - FASTLANE

The FASTLANE study is investigating a medication called tofacitinib, also known as XELJANZ, for people with early and active axial spondyloarthritis. This condition mainly affects the spine, causing back pain and stiffness. The study aims to find out if tofacitinib can help to reduce the disease activity and improve symptoms more effectively than a dummy pill (placebo) or a standard painkiller (Naproxen). Researchers will particularly look at whether participants achieve a state of 'remission' – meaning their disease activity is very low – after 16 weeks. This important research will help doctors understand the best ways to treat this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

104

Start

13 Oct 2023

Axial spondyloarthritis

What is this study about?

This study, called FASTLANE, is designed to test a new treatment called tofacitinib (also known as XELJANZ) for people who have a condition called axial spondyloarthritis. This is a type of arthritis that mostly affects your spine and can cause long-lasting back pain and stiffness. When the condition is 'active', it means symptoms are currently bothering you.

The main goal of this study is to see if tofacitinib can help people feel much better and get their disease activity under control, specifically aiming for something doctors call 'remission'. Remission means your disease activity is very low, and your symptoms are greatly reduced. Researchers will compare tofacitinib against a 'dummy' pill (placebo) and a common painkiller called Naproxen to see which is most effective.

This research is important because it could lead to better ways to manage axial spondyloarthritis, helping people with the condition live more comfortably and with less pain and stiffness. It's about finding out if this particular medicine offers a significant benefit for patients.

Key takeaways

The FASTLANE study explores a new treatment for spinal arthritis.
It aims to see if tofacitinib can reduce disease activity significantly.
The study compares tofacitinib to a dummy pill and a common painkiller.
Participants will be closely monitored for 16 weeks.
This research could lead to better treatments for axial spondyloarthritis.

Who may be eligible?

To join this study, you generally need to be an adult, 18 years or older, and have been diagnosed with active axial spondyloarthritis.

The research team will need to check your medical history and current health to make sure the study medication is safe for you and that the study results will be clear. There might be some specific health details or other medications you're taking that would mean you can't join, but the doctors will discuss all of this with you.

Both men and women can take part in this study. The healthcare team will carefully assess if you fit all the criteria for joining the FASTLANE 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.

Are you 18 years old or older?
Have you been diagnosed with active axial spondyloarthritis?
Are you generally in good health apart from your axial spondyloarthritis?
Are you able to attend regular clinic appointments for the study?
Are you not pregnant or breastfeeding, if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you would receive either the active drug (tofacitinib), a dummy pill (placebo), or Naproxen, and wouldn't know which one you are getting. You would take these medications as instructed. You would have regular visits to the clinic over a period of time, where the study doctors and nurses would check on your health and how you're feeling. These visits might include blood tests, questionnaires about your pain and daily activities, and physical examinations. Some visits might involve things like MRI scans to look at your joints. The study will last for several weeks, and you would be continuously monitored during this time to see how the treatment is working and to ensure your safety.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as receiving a new treatment that could improve your symptoms and condition. You would also receive close medical attention and monitoring from the study team. However, there are potential risks, including side effects from the medication, which would be explained in detail. You might also receive a placebo, meaning you wouldn’t get the active treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Germany
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Czechia

Common questions

What is axial spondyloarthritis?

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

What is tofacitinib (XELJANZ)?

It's a medication that works by calming down an overactive immune system, which can help reduce inflammation in conditions like axial spondyloarthritis.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real drug works better than no treatment at all.

How long will the study last for me?

The study will involve regular visits and monitoring over a period of 16 weeks, specifically checking how you respond to treatment.

Will I know if I'm getting the active drug?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you are receiving tofacitinib, the placebo, or Naproxen until the study is over.