A Clinical Study for People with Myositis

IM101-611 Trial

A Clinical Study for People with Myositis

We are looking for patients who:

  • Have active idiopathic inflammatory myopathy (IIM), like dermatomyositis and polymyositis
  • Are taking medication for myositis

If this sounds like you, consider this clinical study

Why are we running this clinical study?

IM101-611 will answer this major research question about abatacept:

  • Is the combination of abatacept with standard treatment more effective in treating IIM than standard treatment alone?

This question will be answered by comparing results of the two treatment groups.

The Summary of IM101-611

In the IM101-611 clinical study, you may receive abatacept (study drug), which aims to block the proteins that cause inflammation.

In this study you will continue to take the standard treatment you have been receiving for IIM, and you will be assigned to treatment group A or B. For the first 24 weeks of the study, half of the study participants will receive abatacept, and half will receive placebo. Placebo will look like abatacept, but contain no active drug.

After 24 weeks, all study participants will receive abatacept for the next 28 weeks of the study.

What can I expect in this study?

Clinical Study Experience

Everyone participating in IM101-611 will receive the study drug or placebo.

  • You will receive study drugs for the length of the study, at no cost.
  • The study drug will be given by sub-cutaneous (under the skin) injection. Your study doctor will tell you how and how often to take it.
  • Study tests may include blood and urine samples, CT and MRI scans, an X-ray during screening, and physical examinations.
  • You will have 12 office visits and each visit will take about 60–90 minutes.
  • Your study team will call to see how you are feeling between certain visits.
  • Your participation in this study is completely voluntary. You are free to leave this study at any time.

About the Study Drug

Abatacept is currently approved to treat moderate to severe rheumatoid arthritis and polyarticular juvenile idiopathic arthritis. Abatacept has not been approved to treat IIM and is therefore considered an experimental medication in this study. Abatacept works early in the chain of events leading to inflammation, like that seen in IIM. It works by getting in the way of T-cell activation, reducing the amount of
signals that can be sent.

Common Side Effects

Here are some of the most frequently seen side effects experienced by people taking abatacept:

  • Headache
  • Upper respiratory tract infection or cough
  • Nausea
  • Pain and inflamed nose and throat
  • Dizziness

Please see more detailed information about side effects in the Informed Consent Form or discuss with your doctor.

Each study participant’s experience is different. How you respond to study treatment may not be the same as how other study participants respond.

Have any questions?

If you have more questions speak with your doctor or study nurse for more information. If you would like to participate in the study, click the “Apply Here” button to set up a screening appointment.