RecruitingPHASE3INTERVENTIONAL

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis

This study is for people with rheumatoid arthritis (RA) whose current medicines aren't fully controlling their condition. Doctors usually start with standard drugs like methotrexate. If these don't work well, stronger 'biologic' medicines are considered. This trial explores a new treatment plan: starting with a type of biologic called a TNF inhibitor for 12 weeks to quickly reduce inflammation, then switching to another biologic called abatacept for the next 36 weeks. Researchers want to see if this two-step approach is more effective and easier to tolerate compared to just continuing with a TNF inhibitor. They believe this might help some RA patients feel better and achieve lasting remission.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Montpellier

Enrolment target

220

Start

28 Nov 2022

Estimated completion

01 Nov 2027

Rheumatoid Arthritis

What is this study about?

If you have rheumatoid arthritis (RA) that isn't fully controlled by your current medications, this study might be of interest. Typically, doctors first prescribe standard drugs like methotrexate or leflunomide. If these don't work sufficiently, the next step often involves adding stronger medicines, known as 'biologics' or 'targeted synthetic DMARDs', which work in different ways to calm the immune system and reduce inflammation.

Currently, many doctors tend to start with a type of biologic called a TNF inhibitor. However, there's another biologic called abatacept, which is known for having fewer side effects, although some doctors believe it might take a bit longer to start working. This study is designed to see if we can get the best of both worlds. The idea is to begin with a TNF inhibitor for 12 weeks to quickly bring down the inflammation, and then switch to abatacept for the next 36 weeks. The researchers hope this strategy could lead to better control of RA and fewer side effects in the long run, especially for people who have specific markers in their blood (called ACPA positive).

The study compares this new two-step approach against simply continuing with a TNF inhibitor. It's important to understand that this is a research study to find out if this specific sequence of treatments is more effective and safer. It's a way for doctors to explore better treatment options for people living with RA, aiming to help more patients achieve a state where their disease is well-controlled.

Key takeaways

This study explores a new two-step treatment approach for RA.
It's for people whose RA isn't fully controlled by standard medicines.
Compares starting with a TNF inhibitor then switching to abatacept vs. staying on a TNF inhibitor.
Aim is to find a more effective and tolerable treatment path.
Requires ACPA positive RA and no prior use of advanced biologics.
Participation involves regular clinic visits and monitoring for 48 weeks.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have rheumatoid arthritis that has been confirmed by doctors. Your RA must also be considered 'ACPA positive', which is a type of antibody found in your blood that’s common in RA. You must currently be taking methotrexate or leflunomide for at least three months, but these medications aren't fully controlling your RA, meaning you still have some ongoing inflammation.

It's important that you haven't taken other advanced biologics or targeted synthetic medicines for RA before. The study also requires you to have a clear reason why your doctor would typically recommend starting a TNF inhibitor. There are also reasons why you might not be able to join, such as if you have certain heart conditions, untreated tuberculosis, or if you can't commit to all the study visits for 48 weeks. Pregnant or breastfeeding women, or women who could become pregnant and aren't using effective birth control, also cannot participate.

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 rheumatoid arthritis by a doctor?
Are your blood tests 'ACPA positive'?
Are you currently taking methotrexate or leflunomide for at least 3 months, but your RA is not fully controlled?
Have you never taken other advanced biologic or targeted synthetic RA medications before?
Are you able to attend all study visits over 48 weeks (almost a year)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for 48 weeks. You'll be randomly assigned to one of two groups: either you'll start with a TNF inhibitor medicine for 12 weeks and then switch to abatacept for the next 36 weeks, or you'll continue with a TNF inhibitor. You will have regular appointments at the clinic for assessments, which will include blood tests and checks of your RA symptoms and how you're feeling. These visits are important for the doctors to monitor your progress and ensure your safety throughout the study.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as receiving close medical attention and access to new treatment strategies that might work better for your RA. However, there are also potential risks, including side effects from the medicines, which can vary from person to person. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

Centre Hospitalier Universitaire de Montpellier
Verified postcode
Montpellier, France· Recruiting
CHU Bordeaux groupe Pellegrin
Verified postcode
Bordeaux, France· Recruiting
CHU de Brest La Cavale Blanche
Verified postcode
Brest, France· Recruiting
Centre Hospitalier de Cahors
Verified postcode
Cahors, France· Not yet recruiting
CHD Vendée
Verified postcode
La Roche-sur-Yon, France· Recruiting
CH du Mans
Verified postcode
Le Mans, France· Recruiting
CHU de Nantes
Verified postcode
Nantes, France· Recruiting
CHU de Nice
Verified postcode
Nice, France· Recruiting
CHU de Nîmes Carémeau
Verified postcode
Nîmes, France· Not yet recruiting
CHR Orléans Nouvel hôpital d'Orléans
Verified postcode
Orléans, France· Recruiting
APHP Bicêtre
Verified postcode
Paris, France· Not yet recruiting
APHP Cochin
Verified postcode
Paris, France· Recruiting

Common questions

What is ACPA positive?

ACPA positive means you have certain antibodies in your blood that are often found in people with rheumatoid arthritis.

What are TNF inhibitors and abatacept?

These are types of 'biologic' medicines that target specific parts of your immune system to reduce inflammation in rheumatoid arthritis.

How long does the study last?

The study will last for 48 weeks, which is about 11 months.

Will I have to stop my current RA medicine?

You will likely continue your current methotrexate or leflunomide, and the study medicines will be added on top of that.

Is this a new medicine?

The medicines themselves are not new, but this study is looking at a new way of using them in sequence.

How to find out more

Jacques MOREL, MD-PhD

j-morel@chu-montpellier.fr 467338710 Official trial record

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