Active not recruitingPHASE4INTERVENTIONAL

A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease

This research study is investigating an investigational drug called guselkumab for individuals with active psoriatic arthritis (PsA) that affects the spine and/or pelvis. PsA is a long-term condition causing joint pain and inflammation, and sometimes also affects the skin. The main goal is to find out if guselkumab can effectively reduce activity of the disease in these areas. Participants will be randomly assigned to receive either guselkumab or a placebo (a dummy treatment with no active drug) for the first 24 weeks, followed by active treatment for all. Researchers will closely monitor symptoms, inflammation, and any potential side effects. This study aims to provide important information about a potential new treatment option for this specific type of PsA.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Janssen Research & Development, LLC

Enrolment target

411

Start

30 Aug 2021

Estimated completion

13 Apr 2027

Arthritis, Psoriatic

What is this study about?

This study is focused on a specific type of psoriatic arthritis, called axial disease, where the inflammation primarily affects the joints in the spine and pelvis. Psoriatic arthritis is a long-term (chronic) condition that affects joints, causing pain, stiffness, and swelling. It's often linked to psoriasis, a skin condition that causes red, scaly patches.

The drug being tested is called guselkumab. It's designed to work by targeting a specific protein in the body, called IL-23, which is known to play a role in inflammation. By blocking this protein, guselkumab aims to reduce the inflammation and symptoms associated with psoriatic arthritis. We want to understand how effective this drug is at reducing pain and stiffness in the spine and pelvis, and improving the overall health of people with this condition.

This is a Phase 4 study, which means the drug has already undergone significant testing and is now being further evaluated in a larger group of patients. The information gathered from this study will help doctors and patients understand if guselkumab could be a safe and effective treatment option for those living with axial psoriatic arthritis.

Key takeaways

This study is testing a drug called guselkumab for psoriatic arthritis affecting the spine and pelvis.
It aims to reduce pain, stiffness, and inflammation in these areas.
Participants will receive either guselkumab or a dummy treatment (placebo) for the first 24 weeks, then all receive active drug.
The study involves regular clinic visits, blood tests, and scans over a period of up to 14 months.
Potential benefits include access to a new treatment; potential risks include side effects from the drug.

Who may be eligible?

To be considered for this study, you would need to have received a diagnosis of psoriatic arthritis for at least six months. Your arthritis must be active, meaning you have a certain number of swollen and tender joints and specific blood markers of inflammation. Crucially, the arthritis needs to be affecting your spine and/or pelvis, which will be confirmed by a special type of MRI scan. You should also have active skin psoriasis or a history of it.

There are also some criteria that would mean you couldn't join the study. For example, if you have allergies to guselkumab or similar medications, or if you have other inflammatory conditions that might make it difficult to properly assess the study drug's effects. It's also important that you haven't previously received certain types of biologic treatments or specific immunosuppressant medications, including a class of drugs called JAK inhibitors.

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.

I have been diagnosed with psoriatic arthritis for at least 6 months.
My psoriatic arthritis is currently active and affects my spine and/or pelvis.
I have either active skin psoriasis or a history of it.
I have not previously taken certain biologic medications or specific immunosuppressants like JAK inhibitors.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve several stages over a period of up to 14 months (just over one year). Initially, there's a screening phase lasting up to 6 weeks to confirm your eligibility. Following this, the main treatment phase will last for 48 weeks.

During the first 24 weeks of the treatment phase, you will be randomly assigned to receive either guselkumab or a placebo (an inactive dummy treatment). Neither you nor the study team will know which you are receiving. After these 24 weeks, all participants will receive the active guselkumab treatment for another 24 weeks. Throughout the study, you'll have regular visits where the study team will conduct physical examinations, check your vital signs (like blood pressure), take blood and urine samples for lab tests, and perform electrocardiograms (ECGs) to check your heart. We will also monitor any side effects you might experience. There will be a final safety follow-up period after the treatment phase, lasting up to 12 weeks.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as gaining access to a new treatment that might improve your psoriatic arthritis symptoms before it's widely available. You'll also receive careful medical monitoring throughout the study. However, like all medications, guselkumab may have potential side effects, which will be carefully explained to you. There's also a chance you might receive the placebo (dummy treatment) during the first part of the study, meaning your symptoms might not improve during that period. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (240)

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

Arizona Arthritis and Rheumatology Research PLLC 1
Verified postcode
Avondale, United States
Arizona Arthritis & Rheumatology Research, PLLC
Verified postcode
Chandler, United States
Arizona Arthritis and Rheumatology Research PLLC
Verified postcode
Mesa, United States
Arizona Arthritis Research, PLC.
Verified postcode
Phoenix, United States
Arizona Arthritis and Rheumatology Associates
Verified postcode
Sun City, United States
Southern Arizona VA Healthcare System
Verified postcode
Tucson, United States
Unity Health-White County Medical Center
Verified postcode
Searcy, United States
Kaiser Permanent Medical Center
Verified postcode
Fontana, United States
Newport Huntington Medical Group
Verified postcode
Huntington Beach, United States
University Of California San Diego
Verified postcode
La Jolla, United States
Rheumatology Center of San Diego
Verified postcode
San Diego, United States
Clinical Research Center of Connecticut
Verified postcode
Danbury, United States

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that can affect people who have psoriasis. It causes painful, swollen, and stiff joints, and can also affect other parts of the body, including the spine.

What is 'axial disease'?

Axial disease in psoriatic arthritis means the inflammation primarily affects the joints in your spine and/or pelvis, which can lead to back pain and stiffness.

What is a placebo?

A placebo is an inactive substance or treatment that looks exactly like the study drug but contains no medicine. It's used to compare the effects of the actual drug against, to see if the drug really makes a difference.

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

For the first 24 weeks, neither you nor the study team will know if you are receiving guselkumab or the placebo. This helps ensure the study results are unbiased. After 24 weeks, all participants will receive the active guselkumab treatment.

How long will I need to be in the study?

The total duration of your participation in the study, including screening, treatment, and follow-up, will be up to 14 months (just over one year).