Ongoing, recruitingTherapeutic use (Phase IV)Interventional

RCT part: CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. LTE part: CareRA2020 LTE: a 3 year longitudinal observational, multicenter, follow-up of early RA patients after participation in the CareRA2020 RCT.

This study, called CareRA2020, is looking into the best ways to treat people who have recently been diagnosed with rheumatoid arthritis (RA). It’s split into two main parts. The first part compares a common treatment plan (methotrexate with a special steroid plan) with the same plan but with quicker access to a different type of medicine called a 'biological' (like Enbrel or Benepali) if the first plan isn't working well enough. The second part is a longer-term follow-up that watches how people are doing for three years after their initial treatment. The main goal is to see how well these treatments control RA symptoms and keep the disease from getting worse over time.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

UZ Leuven

Enrolment target

442

Start

01 Feb 2024

Rheumatoid Arthritis

What is this study about?

This study, called CareRA2020, is designed to find the best way to treat people who have been recently diagnosed with rheumatoid arthritis, or RA. RA is a long-term condition that causes pain, swelling, and stiffness in the joints. Finding the right treatment early can really help to manage symptoms and prevent further damage.

The study has two main parts. The first part, called the 'RCT,' compares two treatment approaches over two years. Both approaches start with a combination of medicines including methotrexate and a specific steroid plan. However, one group might get faster access to a 'biological' medicine (which targets specific parts of the immune system, like Enbrel or Benepali) if their symptoms aren't improving enough with the initial treatment. The second part, called the 'LTE,' is a longer follow-up for three years after the main study. This helps researchers understand how the treatments work in the long run.

The main aim of the study is to see how well these different treatment plans control RA over time, measuring things like joint pain and swelling. Researchers also want to see if one approach is better at preventing joint damage, if there are any side effects, and how these treatments improve people's daily lives.

Key takeaways

The study explores the best initial treatments for early rheumatoid arthritis.
It compares standard treatment with faster access to 'biological' medicines.
Participation involves regular appointments, blood tests, and potentially X-rays.
The study lasts for several years to track long-term health.
Aims to improve care and long-term outcomes for people with RA.

Who may be eligible?

This study is looking for adults who have recently been diagnosed with rheumatoid arthritis. You must be at least 18 years old to take part.

Both men and women are welcome to participate in this research. The study aims to gather information from a wide range of people to understand how treatments work for different individuals.

There might be other specific health requirements or conditions that would determine if you can join, but your doctor can discuss all of these details with 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 old or older?
Have you recently been diagnosed with rheumatoid arthritis?
Are you able to attend regular clinic appointments?
Are you comfortable with the possibility of receiving different treatments based on random assignment?
Are you willing to participate in a study that involves long-term follow-up?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the necessary requirements. If you're eligible, you would then be randomly assigned to one of the two treatment groups. This means neither you nor your doctor would choose which group you are in, like flipping a coin.

Your participation would involve regular visits to the clinic for assessments, which might include blood tests, physical examinations to check your joints, and possibly X-rays to monitor joint changes. You would receive the study medication as prescribed. The initial part of the study lasts for about two years (104 weeks). After that, there's a longer follow-up period of three years (260 weeks) where researchers will continue to observe how you are doing, without necessarily changing your treatment as part of the study protocol.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving state-of-the-art treatment for your rheumatoid arthritis and close monitoring of your health by medical professionals. This could lead to a better understanding of how to manage your condition effectively. However, like all medical treatments, the medications used in this study may have potential side effects. These will be fully explained to you by the study team. There is also no guarantee that the treatment you receive will be effective for your specific condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is rheumatoid arthritis (RA)?

RA is a long-term condition where your body's immune system mistakenly attacks its own tissues, leading to pain, swelling, and stiffness in your joints, often in your hands and feet.

What is a 'biological' medicine?

Biological medicines are a newer type of drug made from living cells. They target specific parts of your immune system that cause inflammation in conditions like RA.

Why is this study important?

This study helps doctors learn the best and most effective ways to treat people who have just been diagnosed with RA, aiming to reduce symptoms and prevent long-term joint damage.

Will I know which treatment I'm getting?

In the main part of the study, you would be randomly assigned to a treatment group. This means neither you nor your doctor would choose which treatment you receive, to ensure fair comparison.

How long will I be involved in the study?

The main part of the study lasts about two years, followed by a longer observation period of three years to see how patients are doing in the long term.