Todos os estudos
Ainda não recrutandoFASE2, FASE3INTERVENCIONISTA

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

This research study is investigating a medicine called methotrexate for a specific type of severe hand osteoarthritis called erosive hand osteoarthritis. This is for people whose hand pain and stiffness haven't got better with usual treatments. The study aims to see if methotrexate can help reduce further damage to the hand joints. Researchers will compare methotrexate injections with a placebo (a dummy injection that looks the same but contains no medicine) to understand its effectiveness. This is a crucial step in finding better ways to manage this painful condition, and it's currently in the later stages of testing (Phases 2 and 3), meaning it's been through initial safety checks.

Em resumo

Status
Ainda não recrutando
Fase
FASE2, FASE3
Patrocinador
Centre Hospitalier Universitaire de Nice
Meta de inscrição
170
Iniciar
02 May 2026
Conclusão estimada
01 Out 2027

Sobre o que é este estudo?

This study is about a kind of arthritis that affects the hands, specifically called erosive hand osteoarthritis. This form of arthritis can cause significant pain and damage to the small joints in your fingers. Sometimes, standard treatments don't work well enough, and people continue to suffer from discomfort and stiffness.

Researchers are investigating whether a medicine called methotrexate, which is used for some other inflammatory conditions, could be helpful here. They want to see if it can slow down or even stop the damage to the hand joints caused by this type of osteoarthritis. This is important because finding effective treatments for those who don't respond to usual care could dramatically improve their quality of life.

The study is designed as a 'randomized' trial. This means that participants will be randomly assigned to receive either the methotrexate injection or a placebo injection (which looks exactly like the real medicine but contains no active ingredient). This helps researchers fairly compare how well methotrexate works, without anyone knowing whether they're getting the active drug or the placebo until the end of the study. This kind of research is vital for developing new and effective treatments.

Pontos principais

  • This study is for severe hand (erosive) osteoarthritis that hasn't responded to other treatments.
  • It's testing an injected medicine called methotrexate against a dummy treatment (placebo).
  • The goal is to see if methotrexate can reduce joint damage in the hands.
  • Participation involves regular clinic visits for injections and check-ups.
  • You must meet specific health and age criteria to be eligible (40-85 years old).
  • Você pode parar de participar a qualquer momento.

Quem pode ser elegível?

To be considered for this study, you generally need to be between 40 and 85 years old. Your doctor would need to confirm you have osteoarthritis in your finger joints (specifically IPD and IPP joints) based on special criteria, and X-rays taken recently (within the last 3 months) should show damage in at least three of these joints. Your symptoms, like pain and stiffness, should also have been present for more than three months.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant or breastfeeding, or if you've had certain recent injections in your hand joints (like hyaluronic acid in the last 6 months or cortisone in the last 3 months). You also couldn't take part if you have certain other medical conditions like psoriasis, inflammatory arthritis, or serious liver or kidney problems. Similarly, if you have certain infections like hepatitis B, C, HIV, or uncontrolled infections, or if you're taking specific medications like strong painkillers (morphine derivatives), certain antibiotics (Bactrim), or high doses of aspirin, you wouldn't be suitable for this study. Your doctor would carefully check all these points.

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 entre 40 e 85 anos?
  2. Has your doctor diagnosed you with erosive osteoarthritis in your finger joints?
  3. Have your hand pain and stiffness lasted for more than 3 months, even with other treatments?
  4. Have you not had hyaluronic acid injections in your hand in the last 6 months, or cortisone in the last 3 months?
  5. Are you NOT pregnant or breastfeeding and do you NOT have conditions like psoriasis, severe liver/kidney issues, or certain infections?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you would be randomly assigned to receive either methotrexate or a placebo injection. You would need to attend regular appointments for assessments, which might include check-ups, blood tests, and possibly more X-rays of your hands to monitor your condition and how you are responding to the treatment. The injections would be given as part of these visits. The study would involve a period of treatment followed by observation to see the long-term effects. The total duration of your participation would be explained in detail before you agree to join.

Riscos e benefícios potenciais

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. You would also be contributing to medical knowledge that could help countless others with similar conditions in the future. However, there are potential risks, as with any medication, and methotrexate can have side effects. These would be fully explained to you before you consent to participate. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Localizações (1)

  • CHU de Nice
    Código postal verificado
    Nice, France

Perguntas frequentes

What is erosive hand osteoarthritis?

It's a more severe type of hand osteoarthritis where the joint surfaces can become eroded or worn away, often causing more pain and damage than typical osteoarthritis.

What is methotrexate and how is it given?

Methotrexate is a medicine often used for inflammatory conditions. In this study, it's given as an injection, not as a tablet.

O que é um placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but doesn't contain any active drug. It helps researchers fairly compare the active treatment's effects.

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

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving the methotrexate or the placebo until the study is over. This helps keep the results unbiased.

Quanto tempo durará o estudo?

The exact duration of your participation will be fully explained by the study team, but clinical trials often last for several months or even longer.

Como saber mais

Christian ROUX, Pr

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

Interessado em participar?

Registre seu interesse

Compartilhe seus detalhes e a equipe de pesquisa para "Methotrexate Treatment in Hand Osteoarthritis Refractory to …" entrará em contato com você se você for elegível. Sempre fale com seu médico antes de concordar em participar.

Discussão

Discussão da comunidade

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