Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a Multicenter, Randomized, Double Blind, Parallel-group, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Subjects with Active Rheumatoid Arthritis despite Prior Treatment with Advanced Therapies (bDMARD or tsDMARD)

This study is investigating a new way to treat rheumatoid arthritis (RA) that hasn't responded well to current strong medicines. We're looking at a combination of two drugs, nipocalimab and certolizumab (also known as Cimzia). The aim is to see if taking these two medicines together can better reduce RA symptoms, like pain and swelling, compared to existing treatments. This is a phase 2a study, meaning it's an early-stage trial focusing on understanding if the treatment works and what doses are safe. Participants will be adults aged 18 and over who have active RA despite trying other advanced therapies. The main goal is to measure changes in RA activity after 12 weeks of treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen - Cilag International

Enrolment target

Start

09 Oct 2023

Rheumatoid Arthritis

What is this study about?

Rheumatoid arthritis (RA) is a long-lasting condition where your body's immune system mistakenly attacks its own joints, causing pain, swelling, and stiffness. For many people, existing medicines work well to manage these symptoms. However, some individuals continue to experience active RA even after trying strong treatments like biological disease-modifying antirheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs).

This study is called a 'Proof of Concept' study. This means we're exploring if a new combination of medicines, nipocalimab and certolizumab (Cimzia), could be a useful treatment for people whose RA hasn't responded to other advanced therapies. Nipocalimab is a type of drug that works on the immune system, and certolizumab is an established medicine often used for RA. By trying them together, researchers hope to find a more effective way to calm down the immune system and reduce RA symptoms.

Understanding how these two drugs work together is important. If this combination proves effective and safe in this early stage, it could potentially offer a new treatment option for those living with difficult-to-control RA in the future. The study will carefully monitor participants to see how their RA activity changes and to check for any side effects.

Key takeaways

This study explores a new combination of two medicines for rheumatoid arthritis.
It's for adults whose RA hasn't improved with other strong treatments.
The goal is to see if this combination is safe and helps reduce RA symptoms.
Participation involves regular clinic visits, blood tests, and taking study medication.
You have the right to withdraw from the study at any time.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There is no upper age limit, meaning older adults are welcome to participate if they meet other health requirements.

To be considered, you must have active rheumatoid arthritis. This means despite having tried strong treatments for your RA in the past, such as certain biological or targeted synthetic drugs, your arthritis is still causing you problems.

Both men and women can take part in this study. The medical team will check your overall health and specific medical history to make sure the study is a good and safe fit for you. You might already be taking certain medications for your RA that are allowed in this study, such as folic acid, methotrexate, sulfasalazine, chloroquine, hydroxychloroquine, calcium folinate, paracetamol, or leflunomide.

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?
Do you have active rheumatoid arthritis, even though you've tried advanced treatments?
Are you able to attend regular clinic appointments for about 12 weeks?
Do you understand that you might receive the new combination or another treatment?
Are you willing to follow study instructions, including taking medication and having tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of several groups. Some groups will receive the new combination of nipocalimab and certolizumab (Cimzia), while others might receive cimzia with a dummy treatment (placebo), or other standard treatments. You won't know which group you are in, nor will your study doctor, as this helps make the results fair.

You will have regular study visits to the clinic, which will include physical examinations, blood tests, and assessments to check your RA symptoms and how you are responding to the treatment. These visits will be scheduled over about 12 weeks, with follow-up appointments after that to monitor your health.

During the study, you will receive the study medication as prescribed. You might also continue to take some of your usual RA medications like methotrexate, folic acid, or others, as advised by the study team. The total duration of your active participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new treatment that could improve your rheumatoid arthritis symptoms if other treatments haven't worked well. However, there's no guarantee the new treatment will help you, and it might have side effects that are not yet fully known. Potential risks include discomfort from blood tests or injections, and possible reactions to the study medications. Throughout the study, your safety is a top priority, and you are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Poland
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Unverified
Hungary

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness.

What does 'Phase 2a' mean?

Phase 2a is an early stage of clinical research where doctors are trying to figure out if a new treatment works and what the right dose might be, as well as checking its safety.

What are nipocalimab and certolizumab (Cimzia)?

Nipocalimab is a new experimental drug, and certolizumab (Cimzia) is an approved medicine already used for rheumatoid arthritis. This study is looking at using them together.

Will I get the new combination treatment?

Participants are randomly assigned to different treatment groups, so you might get the new combination, or another treatment, or even a dummy treatment along with standard care. You won't know which one you're on to keep the study fair.

How long will the study last for me?

The main treatment period is about 12 weeks, but you will have follow-up visits after that. The study team will give you a detailed timeline.