Active not recruitingPHASE4INTERVENTIONAL

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

This study is for adults with non-radiographic axial spondyloarthritis (nr-axSpA), a type of arthritis mainly affecting the spine, who have responded well to treatment and are now feeling much better. The main goal is to find out if they need to continue taking the medicine called secukinumab to keep their symptoms under control and avoid flare-ups. Participants who have achieved a state of ‘inactive disease’ will be split into two groups: one continues with secukinumab, and the other switches to a placebo (a dummy treatment). Researchers will then compare how many people in each group remain free from symptom flare-ups over two years. This helps understand if ongoing treatment is essential for maintaining remission in this condition.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Novartis Pharmaceuticals

Enrolment target

240

Start

28 Mar 2023

Estimated completion

04 Apr 2028

Non-radiographic Axial Spondyloarthritis

What is this study about?

This study is designed for individuals living with non-radiographic axial spondyloarthritis (nr-axSpA). This condition is a type of inflammatory arthritis that primarily affects the spine, causing pain and stiffness, but it doesn't show up on standard X-rays. The study aims to understand if patients who have successfully improved their symptoms with a medicine called secukinumab need to continue taking it long-term to maintain these improvements.

Imagine you've been taking a treatment that has made you feel much better, almost symptom-free. This study wants to know if you can safely reduce or stop that treatment without your symptoms returning. Participants who have reached a point where their disease is considered 'inactive' (meaning symptoms are very low or gone) will be randomly put into one of two groups. One group will continue to receive secukinumab, and the other will switch to a 'placebo', which looks like the real medicine but contains no active drug. This comparison helps researchers see if continuing secukinumab is truly necessary to prevent symptoms from flaring up again.

The main thing the researchers will be looking for is how many people in each group remain free from a flare-up of their symptoms over a period of about two years. The results of this study could help doctors and patients make better decisions about treatment plans for non-radiographic axial spondyloarthritis in the future, particularly regarding how long medicines like secukinumab should be taken once someone is feeling better.

Key takeaways

The study investigates whether continuing secukinumab is necessary to maintain improvement in nr-axSpA.
It involves comparing secukinumab with a placebo in patients whose symptoms are already well-controlled.
The main goal is to see how many people stay flare-free for about two years.
Participation includes regular clinic visits for monitoring and medication.
Learning from this study could help guide future treatment decisions for nr-axSpA.

Who may be eligible?

To join this study, you need to be an adult at least 18 years old. You must have a clear diagnosis of non-radiographic axial spondyloarthritis, which means you've had back pain for at least six months that started before you turned 45. Doctors also need to see signs of inflammation on an MRI scan of your lower back or through a blood test showing high inflammation levels.

Your spondyloarthritis symptoms should be active at the start of the study, meaning you have noticeable back pain and other symptoms. You also need to have tried at least two different anti-inflammatory pain medications (NSAIDs) for a good amount of time, but they didn't help enough, or you couldn't take them due to side effects.

You cannot join if your spondyloarthritis shows up clearly on X-rays (this is a different, more advanced type). You also can't take strong opioid pain medications. If you've previously used secukinumab or certain other biological treatments for your condition, you might not be able to join, especially if you stopped them because they weren't working. If you stopped a specific type of biologic treatment called a TNF inhibitor for reasons other than it not working, you might be able to join after a waiting period.

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 or older?
Do you have a diagnosis of non-radiographic axial spondyloarthritis?
Have you had inflammatory back pain for at least 6 months, starting before age 45?
Are your symptoms currently active, with noticeable back pain and overall symptoms?
Have standard anti-inflammatory pain medications (NSAIDs) not worked well for you?
Have you NOT had previous secukinumab treatment or most other biologic treatments for your condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study could last up to 128 weeks, which is about 2 and a half years. For most of this time (up to 120 weeks), you'll be receiving the study medication. Initially, you'll visit the clinic about a month after starting, and then roughly every 12 weeks for the first part of the study.

During a later part of the study, visits will be more frequent, about every 4 weeks. At these visits, doctors and nurses will monitor your health, assess your symptoms, and make sure the treatment is safe for you. You'll receive either secukinumab or a placebo (dummy drug) via an injection using a prefilled syringe. Since this is a 'double-blind' study, neither you nor the study team will know whether you are receiving the active drug or the placebo, to keep the results fair and unbiased.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as receiving close medical attention and access to a new treatment, which might help manage your condition. However, there are also potential risks, including side effects from the medication or the possibility of receiving a placebo, meaning your symptoms might not improve or could even worsen. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (62)

Novartis Investigative Site
Verified postcode
Bruges, Belgium
Novartis Investigative Site
Verified postcode
Genk, Belgium
Novartis Investigative Site
Verified postcode
Ghent, Belgium
Novartis Investigative Site
Verified postcode
Mons, Belgium
Novartis Investigative Site
Verified postcode
Juiz de Fora, Brazil
Novartis Investigative Site
Verified postcode
Porto Alegre, Brazil
Novartis Investigative Site
Verified postcode
Barretos, Brazil
Novartis Investigative Site
City only
Bogota, Colombia
Novartis Investigative Site
City only
Bogota, Colombia
Novartis Investigative Site
Verified postcode
Chía, Colombia
Novartis Investigative Site
Verified postcode
Bucaramanga, Colombia
Novartis Investigative Site
Verified postcode
Prague, Czechia

Common questions

What is non-radiographic axial spondyloarthritis (nr-axSpA)?

It's a type of inflammatory arthritis that mainly causes pain and stiffness in the spine, but it doesn't show up on regular X-rays.

What is secukinumab?

Secukinumab is a medicine used to treat certain inflammatory conditions, including some types of arthritis.

What does 'remission' mean in this study?

Remission means your condition is 'inactive', with very low or no symptoms of your spondyloarthritis.

What is a placebo?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps compare the effects of the active medicine fairly.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know if you're receiving secukinumab or the placebo until after the study is complete, keeping the results unbiased.