RecruitingPHASE2INTERVENTIONAL

Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis

This research study is investigating a new way to treat a type of arthritis called immune checkpoint inhibitor-associated inflammatory arthritis (ir-IA). This condition can develop in people who are receiving certain cancer treatments. The study focuses on using a medication called adalimumab early on, when the arthritis first appears. Adalimumab is a common medicine for other types of inflammatory arthritis. Researchers want to find out if giving adalimumab at an early stage can help reduce the arthritis symptoms and, importantly, lower the need for strong steroid medications like prednisone. Participants will be randomly assigned to either receive adalimumab or continue with the usual steroid treatment to compare their effects over 12 weeks.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Tom Appleton

Enrolment target

Start

15 Apr 2024

Estimated completion

01 Dec 2028

Inflammatory Arthritis Immune-related Adverse Event

What is this study about?

This study is looking into a specific type of arthritis called immune checkpoint inhibitor-associated inflammatory arthritis, often shortened to ir-IA. This condition can sometimes affect people who are undergoing certain cancer treatments that boost their immune system. While these cancer treatments are very important, they can sometimes cause the immune system to become overactive and attack healthy tissues, leading to inflammation and arthritis symptoms like joint pain and swelling.

Currently, steroids like prednisone are often used to manage this type of arthritis, but long-term steroid use can have side effects. This study aims to see if an existing medication called adalimumab could be a better option when started early. Adalimumab is already a well-known treatment for other forms of inflammatory arthritis and works by calming the immune system.

The main goal is to see if treating ir-IA with adalimumab early on can help relieve symptoms and, crucially, reduce how much steroid medication people need. By potentially lowering steroid use, doctors hope to offer a treatment that could improve patients' quality of life with fewer side effects. The study is set up to compare adalimumab against the standard steroid treatment to understand which approach is more effective.

Key takeaways

This study explores an early treatment for inflammatory arthritis linked to certain cancer therapies.
It aims to see if adalimumab can reduce arthritis symptoms and the need for steroid medications.
Participation involves being randomly assigned to either adalimumab or standard steroid treatment.
The study lasts 12 weeks with regular checks for your safety and condition.
You have the right to withdraw from the study at any time.
Your doctor will discuss all potential risks and benefits with you.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and have recently developed inflammatory arthritis (within the last 6 months). This arthritis needs to have started while you were taking a specific type of cancer treatment (called an immune checkpoint inhibitor) or very soon after stopping it. Your doctor must confirm you have inflammation in at least one joint, tendon, or area where tendons attach to bone.

Also, your arthritis must be serious enough that you've needed steroids like prednisone, either by taking at least 10mg daily or if previous attempts to reduce your steroid dose didn't work to control your symptoms. It's important that this type of arthritis is new for you; you can't have had a previous diagnosis of other inflammatory conditions like rheumatoid arthritis or lupus.

There are also some important safety checks. You'll need to have had a negative test for tuberculosis (TB) in the last year, especially if you're in the group receiving adalimumab. You also can't have any medical reasons that would prevent you from safely taking adalimumab, such as a serious ongoing infection. Your doctor will carefully review your medical history to make sure the study is a safe option for you.

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?
Did your inflammatory arthritis start within the last 6 months while on or just after cancer treatment (immune checkpoint inhibitors)?
Have you been needing steroids (like Prednisone) for your arthritis, or has your arthritis not improved when you tried to reduce steroids?
Have you had a negative TB test in the last year (if applicable)?
Have you *not* been diagnosed with another type of inflammatory arthritis (like rheumatoid arthritis) before this recent episode?
Do you have no medical reasons that would prevent you from taking adalimumab safely?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of two groups, like flipping a coin. One group will receive adalimumab injections for 12 weeks (six doses in total) along with their usual care. The other group will follow the standard treatment of using steroid medication, which will be gradually reduced over 12 weeks.

Throughout the study, you'll have regular hospital visits for assessments. These will include check-ups with a rheumatologist (a doctor specialising in arthritis), physical examinations to check your joints, and potentially blood tests to monitor your condition and the effects of the medication. The study will last for a total of 12 weeks, during which your doctors will closely monitor your symptoms and how much steroid medicine you need.

Potential risks and benefits

Taking part in this study could offer the potential benefit of better controlling your arthritis symptoms and possibly reducing your need for steroid medications, which can have side effects. However, like all medications, adalimumab has potential risks, including a higher chance of infections or reaction at the injection site. Steroids also have their own known side effects. The research team will explain all potential risks in detail, and your safety will be closely monitored throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

St. Joseph's Health Care
Verified postcode
London, Canada· Recruiting

Common questions

What is immune checkpoint inhibitor-associated inflammatory arthritis?

It's a type of arthritis that can develop in people receiving certain cancer treatments that boost their immune system, causing joint pain and swelling.

What is adalimumab?

Adalimumab is a medication that helps calm an overactive immune system, commonly used to treat inflammatory conditions like other types of arthritis.

Will I still take steroids in the study?

One group will gradually reduce steroids over 12 weeks. The other group will receive adalimumab and might also be able to reduce their steroids, which is what the study aims to find out.

How long does the study last?

The main treatment and observation period for the study is 12 weeks.

What does 'randomized' mean?

It means you'll be assigned to one of the treatment groups by chance, like drawing lots, to ensure a fair comparison between the treatments.

How to find out more

Tom Appleton, MD, PhD, FRCPC

tom.appelton@sjhc.london.on.ca 519-646-6100 Official trial record

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