Active not recruitingPHASE2INTERVENTIONAL

A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)

The RENOIR study is testing a new drug called Rosnilimab for adults aged 18 to 65 who have moderate to severe rheumatoid arthritis. This condition causes pain and swelling in joints. We are comparing Rosnilimab to a 'placebo' (a dummy drug with no active ingredients) to see if it's both safe and effective in improving symptoms. Participants will be randomly assigned to receive either Rosnilimab or the placebo. Researchers will carefully monitor participants throughout the study to understand how the new medication works and if it can offer a new treatment option for rheumatoid arthritis. Taking part could help us learn more about this condition and discover new ways to manage it, potentially benefiting many people in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AnaptysBio, Inc.

Enrolment target

420

Start

31 Aug 2023

Estimated completion

30 May 2025

Rheumatoid Arthritis

What is this study about?

This study, called RENOIR, is looking into a new medicine named Rosnilimab for people living with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints. For some people, current treatments don't work well enough, and new options are needed.

The main goal of this study is to find out if Rosnilimab is safe to use and whether it can help improve the symptoms of moderate to severe rheumatoid arthritis. To do this, some people in the study will receive Rosnilimab, while others will receive a 'placebo', which looks like the study drug but doesn't contain any active medicine. This comparison helps us understand the true effects of Rosnilimab.

By taking part, you could contribute to important research that might lead to a new treatment for rheumatoid arthritis. This could potentially help improve the lives of many people with this condition in the future.

Key takeaways

Tests a new medicine (Rosnilimab) for rheumatoid arthritis.
Compares Rosnilimab to a dummy treatment (placebo).
Aimed at adults aged 18-65 with moderate to severe RA.
Could help find new treatment options for rheumatoid arthritis.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To join this study, you generally need to be an adult aged 18 to 65 years old and have been diagnosed with rheumatoid arthritis for at least three months. It's important that you are currently taking one or two standard rheumatoid arthritis medications (DMARDs) and have been on a steady dose of these for at least eight weeks before the study begins. You should also have found that at least one of your previous rheumatoid arthritis medications hasn't worked well enough for you, or you haven't been able to tolerate it.

There are also some reasons why you might not be able to join. For example, if you have other inflammatory joint diseases, or if you've had certain types of cancer in the last five years, you wouldn't be eligible. The study also can't include people who have a weakened immune system, or if you are pregnant or breastfeeding. If you've previously taken certain immune-system-affecting drugs, this would also prevent you from joining.

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 to 65 years old?
Do you have a diagnosis of rheumatoid arthritis for at least 3 months?
Are you currently taking 1 or 2 standard rheumatoid arthritis medicines (DMARDs) at a steady dose?
Has at least one of your past rheumatoid arthritis medicines not worked well or caused problems?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive Rosnilimab or a placebo (a dummy drug). This means neither you nor your study doctor will know which treatment you are receiving. You will need to attend regular appointments at the clinic over a period of time. These visits will involve various health checks, blood tests, and discussions about how you are feeling and any symptoms you are experiencing. You will also be given the study medication to take as instructed. The total duration of your participation in the study, including all follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study means you could potentially benefit from a new treatment for your rheumatoid arthritis, and you would be contributing to valuable medical research that could help others. However, there are also potential risks, as Rosnilimab is an investigational drug and its full effects are not yet known. Like all medications, it could cause side effects. The study team will explain all known risks to you before you decide to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (92)

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

AnaptysBio Investigative Site 10-132
Verified postcode
Flagstaff, United States
AnaptysBio Investigative Site 10-130
Verified postcode
Glendale, United States
AnaptysBio Investigative Site 10-129
Verified postcode
Phoenix, United States
AnaptysBio Investigative Site 10-131
Verified postcode
Tucson, United States
AnaptysBio Investigative Site 10-105
Verified postcode
Covina, United States
Anaptys Bio Investigative Site 10-119
Verified postcode
Rancho Mirage, United States
AnaptysBio Investigative Site 10-113
Verified postcode
San Diego, United States
AnaptysBio Investigative Site 10-127
Verified postcode
San Francisco, United States
AnaptysBio Investigative Site 10-136
Verified postcode
Temecula, United States
AnaptysBio Investigative Site 10-133
Verified postcode
Upland, United States
AnaptysBio Investigative Site 10-112
Unverified
Whitter, United States
AnaptysBio Investigative Site 10-103
Verified postcode
Aventura, United States

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition that causes your immune system to mistakenly attack your joints, leading to pain, swelling, and stiffness.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the study drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.

Will I know if I'm getting the drug or the placebo?

No, you won't. This is called 'double-blind,' and it means neither you nor the doctors will know, to keep the study results fair.

How long does the study last?

The precise length will be explained by the study team, but it involves several months of treatment and follow-up visits.

Can I stop taking part if I change my mind?

Yes, you can stop participating at any point, for any reason, without it affecting your current medical care.