Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

This research study is looking for adults with early, seropositive rheumatoid arthritis to compare two treatments: abatacept and adalimumab. Participants will already be taking methotrexate, but their arthritis hasn't improved enough. The study aims to find out if one of these medications is more effective than the other at controlling rheumatoid arthritis symptoms and improving how participants feel overall. Doctors hope to learn which treatment works best for specific patients with more advanced signs of the condition, helping more people get better relief from their symptoms and live fuller lives. It's a late-stage clinical trial, meaning the medications have already been tested for safety in earlier studies.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

338

Start

15 Sep 2021

Estimated completion

01 Sep 2027

Rheumatoid Arthritis

What is this study about?

Rheumatoid arthritis (RA) is a long-term condition that causes pain, swelling, and stiffness in the joints. It happens when the body's immune system, which normally fights off infections, mistakenly attacks the lining of the joints. This can lead to joint damage and affect daily activities. Finding the right treatment early can help manage symptoms and prevent further damage.

This study is designed for people who have been recently diagnosed with rheumatoid arthritis – specifically, those with a type known as 'seropositive' and 'shared epitope-positive' RA, which means certain markers show in their blood tests that can indicate more aggressive disease. These patients have also tried methotrexate, a common RA medication, but it hasn't worked well enough to control their symptoms. The researchers want to compare two other advanced medications, abatacept and adalimumab, to see which one might be more effective for this specific group of patients.

The main goal is to find out if abatacept works better than adalimumab in reducing the signs and symptoms of rheumatoid arthritis. Both of these are 'biologic' medicines, which target specific parts of the immune system involved in RA. By finding out which treatment is superior, doctors can make more informed decisions about how to best help people with early, active rheumatoid arthritis to achieve better symptom control and improve their quality of life.

Key takeaways

This study compares two advanced treatments (abatacept and adalimumab) for rheumatoid arthritis.
It's for adults whose early RA hasn't improved enough with methotrexate.
Participants have a specific type of RA that can be more active.
The goal is to find out which treatment works better for these patients.
You'll receive close medical care and regular check-ups during the study.

Who may be eligible?

This study is looking for adults aged 18 and over who have been recently diagnosed with rheumatoid arthritis, meaning your symptoms started within the last year. You must have already been taking methotrexate for at least 3 months, at a steady dose for the last month, but your arthritis is still active and not well-controlled. Your blood tests must also show specific markers for rheumatoid arthritis, suggesting a more severe form of the condition. You will also need to have a certain number of tender and swollen joints, and your doctor will use a specific score (DAS28-CRP) to confirm your arthritis is active enough to join.

There are several reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have other autoimmune conditions like psoriasis or lupus. You also can't participate if you've already tried other 'biologic' or similar advanced arthritis medications. The study also cannot include anyone who has had certain infections, such as tuberculosis, or who has a weakened immune system, as these medications can affect your immune response. You also cannot have certain other conditions that might interfere with the study's safety or results.

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?
Were your RA symptoms diagnosed within the last 12 months?
Have you been taking methotrexate for at least 3 months, and for a steady dose for the last month?
Are your rheumatoid arthritis symptoms still active despite methotrexate?
Do your blood tests show specific markers for rheumatoid arthritis (seropositive)?
Are you currently not pregnant or breastfeeding, and do not have certain other serious health conditions or infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given either abatacept or adalimumab, in addition to your current methotrexate. You won't know which of the two study drugs you are receiving, nor will your study doctor, which helps keep the study fair and unbiased. Your participation will involve regular visits to the clinic for medical check-ups, blood tests, and assessments of your joints to see how your arthritis is responding to treatment. You'll also be asked about your symptoms and how you're feeling. The study will last for a specific period, and detailed information about the time commitment and schedule of visits will be provided to you by the study team. You'll continue to receive regular medical care throughout the study.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as receiving close medical monitoring and access to advanced treatments for your rheumatoid arthritis. It also helps advance medical knowledge, potentially benefiting others with RA in the future. However, there are potential risks, primarily side effects from the study medications, which can vary from mild to severe, and will be fully explained to you by the medical team. There is also no guarantee that the study medication will improve your condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (75)

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

Local Institution - 0036
Verified postcode
Fullerton, United States
Local Institution - 0086
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Los Alamitos, United States
Local Institution - 0041
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Aurora, United States
Local Institution - 0058
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Cumberland, United States
Local Institution - 0038
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Hagerstown, United States
Local Institution - 0084
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Eagan, United States
Local Institution - 0040
Verified postcode
Freehold, United States
NYU Langone Ambulatory Care Brooklyn Heights
Verified postcode
Brooklyn, United States
Local Institution - 0082
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Wilmington, United States
Local Institution - 0127
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Portland, United States
Local Institution - 0031
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Duncansville, United States
Local Institution - 0034
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Jackson, United States

Common questions

What is 'seropositive' rheumatoid arthritis?

This means blood tests show specific markers (like rheumatoid factor and anti-CCP antibodies) which confirm rheumatoid arthritis and can sometimes mean a more active form of the disease.

What is methotrexate?

Methotrexate is a common medication used to reduce inflammation and slow down the progression of rheumatoid arthritis. It's often one of the first treatments doctors try.

What does a 'Phase 3' study mean?

Phase 3 means these medications have already been tested in earlier studies for safety and some effectiveness. This phase compares them to existing treatments or other new treatments in a larger group of people to confirm their benefits and check for any less common side effects.

Will I know which treatment I'm getting?

No, in this type of study, neither you nor your study doctor will know whether you are receiving abatacept or adalimumab. This helps ensure the results are unbiased and reliable.

How long will the study last?

The exact duration for each participant will be explained by the study team, but clinical trials usually involve a commitment over several months or even a couple of years, with regular clinic visits.