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A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

This research study is for adults living with specific muscle conditions, such as myositis, dermatomyositis, or polymyositis. We are looking into a new medication called efgartigimod, given as an injection under the skin. The main goal is to understand if this medicine is safe and effective for long-term use in people who have already tried it in a previous study. Participants will receive the medicine for up to 51 months, and then their health will be checked for two more months after they stop taking it. This helps researchers learn more about how the medicine works over time and if it can improve the lives of those with these conditions.

Em resumo

Status
Inscrição por convite
Fase
FASE3
Patrocinador
argenx
Meta de inscrição
240
Iniciar
12 Sep 2023
Conclusão estimada
01 Set 2028

Sobre o que é este estudo?

This study is investigating a new medication called efgartigimod, which is given as an injection under the skin, for adults with certain muscle diseases. These diseases are sometimes called idiopathic inflammatory myopathies, which include conditions like dermatomyositis, polymyositis, and immune-mediated necrotizing myopathy. These conditions can cause muscle weakness and other symptoms.

The main purpose of this research is to see how safe and helpful efgartigimod is over a long period. All participants in this study would have already taken part in a previous study for efgartigimod. This follow-up study helps doctors understand the long-term effects of the medication.

By taking part, you would help doctors learn more about this medication. This knowledge could potentially lead to better treatments for people with these challenging muscle conditions in the future.

Pontos principais

  • This study evaluates a new medication called efgartigimod for muscle conditions.
  • It's a long-term study for adults who participated in a previous trial.
  • The medication is given as an injection under the skin.
  • The main goals are to check the medication's long-term safety and effectiveness.
  • Participation helps future patients with these conditions.

Quem pode ser elegível?

To join this study, you must be an adult aged 18 or older and have previously taken part in a specific trial called ARGX-113-2007. You should be able to understand the study details and give your official consent to participate.

There are also some reasons why you might not be able to join. For example, if you plan to have major surgery during the study, or if you've developed a serious medical condition since the last study that the doctors think would make it risky for you to participate or affect the study results. You also can't take part if you are allergic to the study medicine or any of its ingredients, or if you've developed any new or returning cancer (other than a common type of skin cancer).

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. Você tem 18 anos ou mais?
  2. Did you previously take part in the ARGX-113-2007 study?
  3. Are you able to follow study instructions and give your informed consent?
  4. Are you not planning to have major surgery during the study?
  5. Are you not allergic to the study drug or its ingredients?
  6. Have you not developed any new cancer (other than certain skin cancers)?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to join this study, you will receive the study medication, efgartigimod, as an injection under your skin regularly for up to 51 months (about 4 years and 3 months). During this time, you will have regular visits to the clinic so doctors can monitor your health and how the medication is affecting you. After you finish taking the medication, there will be a follow-up period of about 8 weeks (56 days) where your health will continue to be checked to ensure your safety. The total duration of your involvement could be up to 53 months, including the treatment and follow-up periods.

Riscos e benefícios potenciais

Taking part in this study may offer potential benefits, such as continued access to a new medication for your condition and close medical monitoring. However, there are potential risks, including side effects from the medication or the need for frequent clinic visits. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Localizações (92)

  • Neuromuscular Clinical and Research Center - Neurology
    Código postal verificado
    Phoenix, Estados Unidos
  • Attune Health Research, Inc
    Código postal verificado
    Beverly Hills, Estados Unidos
  • UCI Health - ALS and Neuromuscular Center - Neurology
    Código postal verificado
    Orange, Estados Unidos
  • UCSF Health - ALS and Neurodegenerative Disease Center - Dermatology
    Código postal verificado
    São Francisco, Estados Unidos
  • Yale Cancer Center-Yale University School Of Medicine
    Código postal verificado
    New Haven, Estados Unidos
  • UF Health - Rheumatology Medical Specialties Medical Plaza
    Código postal verificado
    Gainesville, Estados Unidos
  • Mayo Clinic - Florida - Neurology
    Código postal verificado
    Jacksonville, Estados Unidos
  • University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)
    Código postal verificado
    Tampa, Estados Unidos
  • Emory Healthcare - Emory Clinic - Rheumatology
    Código postal verificado
    Atlanta, Estados Unidos
  • Northwestern Medicine - Northwestern Memorial Hospital
    Código postal verificado
    Chicago, Estados Unidos
  • John Hopkins Medicine - Johns Hopkins Myositis Center
    Código postal verificado
    Baltimore, Estados Unidos
  • Northwell Health Physician Partners Rheumatology
    Código postal verificado
    Great Neck, United States

Perguntas frequentes

What is efgartigimod?

Efgartigimod is the name of the study medication being tested for treating certain muscle conditions.

What medical conditions are being studied?

The study focuses on adult patients with specific muscle conditions, such as myositis, dermatomyositis, and polymyositis.

How is the study medicine given?

The study medicine is given as an injection under the skin.

Quanto tempo estarei no estudo?

You could be in the study for up to 51 months receiving the treatment, plus a two-month follow-up period, making the total up to roughly 4 and a half years.

Posso sair do estudo a qualquer momento?

Yes, you are free to leave the study at any point without having to give a reason and without your medical care being affected.

Como saber mais

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

Interessado em participar?

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