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Ativo, mas não recrutandoFASE2INTERVENCIONISTA

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.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2
Patrocinador
AnaptysBio, Inc.
Meta de inscrição
420
Iniciar
31 Ago 2023
Conclusão estimada
30 May 2025

Sobre o que é este estudo?

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.

Pontos principais

  • 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.

Quem pode ser elegível?

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.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Are you 18 to 65 years old?
  2. Do you have a diagnosis of rheumatoid arthritis for at least 3 months?
  3. Are you currently taking 1 or 2 standard rheumatoid arthritis medicines (DMARDs) at a steady dose?
  4. Has at least one of your past rheumatoid arthritis medicines not worked well or caused problems?
  5. Você não está grávida ou amamentando?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

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.

Riscos e benefícios potenciais

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.

Localizações (92)

  • AnaptysBio Investigative Site 10-132
    Código postal verificado
    Flagstaff, United States
  • AnaptysBio Investigative Site 10-130
    Código postal verificado
    Glendale, Estados Unidos
  • AnaptysBio Investigative Site 10-129
    Código postal verificado
    Phoenix, Estados Unidos
  • AnaptysBio Investigative Site 10-131
    Código postal verificado
    Tucson, Estados Unidos
  • AnaptysBio Investigative Site 10-105
    Código postal verificado
    Covina, United States
  • Anaptys Bio Investigative Site 10-119
    Código postal verificado
    Rancho Mirage, United States
  • AnaptysBio Investigative Site 10-113
    Código postal verificado
    San Diego, Estados Unidos
  • AnaptysBio Investigative Site 10-127
    Código postal verificado
    São Francisco, Estados Unidos
  • AnaptysBio Investigative Site 10-136
    Código postal verificado
    Temecula, United States
  • AnaptysBio Investigative Site 10-133
    Código postal verificado
    Upland, United States
  • AnaptysBio Investigative Site 10-112
    Apenas cidade
    Whitter, United States
  • AnaptysBio Investigative Site 10-103
    Código postal verificado
    Aventura, Estados Unidos

Perguntas frequentes

O que é artrite reumatoide?

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

O que é um '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.

Quanto tempo dura o estudo?

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

Posso parar de participar se mudar de ideia?

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

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

Discussão da comunidade

Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.