Comparing single drug (prednisone alone) with combination drug (prednisone + methotrexate) treatment in people with polymyositis or dermatomyositis

Start Date
01/05/2008
Expected end Date
01/04/2012
Location
Europe
Status
Recruiting

What is the aim of the trial?

This phase 3 trial will compare the use of a single drug (prednisone) with the use of a combination of two drugs (prednisone and methotrexate). The main aim is to find out if the combined treatment is safe and more effective than single drug treatment.

Polymyositis and dermatomyositis are both diseases in which the immune system mistakenly attacks the body’s own tissues (“autoimmunity”). This inappropriate immune response can result in chronic inflammation of muscle and skin. This is usually treated with “steroid” hormones (also known as corticosteroids) that slow down the immune response and reduce inflammation.

In this trial, the steroid prednisone is used in combination with another drug (methotrexate), which is also known to suppress the immune response. The study will show if methotrexate and prednisone are safe if used together, and if their combination improves the treatment.

This study is similar to another trial focusing on dermatomyositis in children (see link below under the heading “Background information and related links”).

Who can be involved in the trial?

This trial aims to recruit 50 people aged between 18 and 80 years. Participants must have a confirmed diagnosis of dermatomyositis or polymyositis. Their physician must judge them suitable for immunosuppressive treatment.

People are not eligible if they have been treated with any immunosuppressive drugs before the trial (except a maximum of 8 weeks prednisone treatment). Also excluded are pregnant women, children and people with immunodeficiency syndrome, HIV or inclusion body myositis.

Some heart, kidney, digestive or hormonal problems may also exclude participation.

What happens during the trial?

The 50 study participants will be randomly divided into two groups of 25. Both groups receive prednisone at a starting dose of 1 mg per kg body weight per day. Methotrexate will be given only to the first group, starting with 10 mg per week increasing to 25 mg. Five to ten mg of folic acid will be given as tablets 24 hours after methotrexate.

Treatment lasts 12 months with a final exam after 24 months. Participants will undergo different tests during and after the trial. These include exams of muscle strength, blood and urine tests, muscle biopsies (removal of a small tissue sample), magnetic resonance imaging and questionnaires.

Samples of genetic material (DNA and RNA) will also be taken and stored for potential future studies.

Where is the study taking place?

The study will take place in:
• Institute of Rheumatology, Prague, Czech Republic
• Stockholm, Sweden
• Warsaw, Poland
• Debrecin, Hungary
• Zurich, Switzerland

In most circumstances, for somebody to participate in a clinical trial, they need to live near the team of people who are conducting the research, because they need to be closely monitored.

How could the results of the trial benefit patients?

The trial will show if combined treatment with prednisone and methotrexate is safe and more effective than prednisone alone. If successful, the combined treatment may be implemented into clinical practice giving doctors another treatment option to offer patients with polymyositis and dermatomyositis especially if they don’t respond to steroid treatment on its own. Longer term safety and outcome may also be monitored in a phase 4 clinical trial.

Trial results:

The results of this trial are expected to be available 2013.

Contact Details:

Jiri Vencovsky

Tel: +42 (0)2 3407 5340

Email: venc@revma.cz

Who is funding this study?

  • Institute of Rheumatology, Prague, Czech Republic
  • Karolinska Institutet, Stockholm, Sweden

Official name of the Trial:

A Prospective, Randomised, Assessor-blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients with polymyositis and dermatomyositis.

Trial study number:

NCT00651040

Further trial details:

For further information on the trial and detailed inclusion and exclusion please click on the link below. Sometimes these details can be quite technical. If you have any questions please discuss this with your clinician or contact the clinical trial organisers.

http://clinicaltrials.gov/show/NCT00651040

Background information and related links:

This phase 3 trial will compare the use of a single drug (prednisone) with the use of a combination of two drugs (prednisone and methotrexate). The main aim is to find out if the combined treatment is safe and more effective than single drug treatment.

Polymyositis and dermatomyositis are both diseases in which the immune system mistakenly attacks the body’s own tissues (“autoimmunity”). This inappropriate immune response can result in chronic inflammation of muscle and skin. This is usually treated with “steroid” hormones (also known as corticosteroids) that slow down the immune response and reduce inflammation.

In this trial, the steroid prednisone is used in combination with another drug (methotrexate), which is also known to suppress the immune response. The study will show if methotrexate and prednisone are safe if used together, and if their combination improves the treatment.

This study is similar to another trial focusing on dermatomyositis in children (see link below under the heading “Background information and related links”).

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