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Information for Study Participants

The Rituximab Study

Status: No Longer Recruiting

Eligibility Criteria

To join this study, you must fulfill the conditions below:

  • were diagnosed with type 1 diabetes within the past 3 months.
  • are 8 to 45 years of age.
  • have blood tests that show your body is still making insulin.
  • have antibodies in your blood that are present in people with type 1 diabetes.
  • are willing to use birth control and take urine pregnancy tests at regular intervals (if female and sexually active).
  • agree to manage your diabetes daily. This means checking your blood sugar 3 to 4 times each day and taking multiple insulin injections or using an insulin pump.

You cannot be in the rituximab study, if you:

  • had any immunizations within 1 month of starting the study.
  • have any medical conditions that would make it difficult or unsafe for you.
  • have certain infections like HIV, hepatitis, or tuberculosis.
  • take medicine (like steroids) for other conditions that make your immune system less active.
  • are pregnant or lactating, or expect to get pregnant during the study.
  • have a history of serious illness (like cancer, for example).
  • use non-insulin medications that affect your blood sugar.
  • are already in another type 1 diabetes treatment study.
  • have chronic lymphopenia.

About this Study

The goal of the study is to find out if the medicine rituximab can prevent further beta cell destruction. Rituximab has been successfully used in other illnesses to slow down the immune response. TrialNet researchers hope it will help here to scale down the attack on beta cells and allow them to keep making insulin. Even if rituximab works, you will still need to take insulin but your blood sugar (glucose) should be easier to control.

With your blood sugar controlled better, you'll have less chance of getting a) severe hypoglycemia (low blood sugar), and b) long-term problems of diabetes such as blindness, kidney failure, nerve damage, heart attack, and stroke.

Scientists have learned that two types of immune cells, B cells and T cells, are involved in causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells that make insulin. Although they don't attack insulin producing cells, B cells may be what trigger the T cells to attack.

With fewer insulin producing cells your blood glucose increases, causing hunger, thirst, and unexplained weight loss. By the time you have these symptoms, many (but not all) insulin producing cells have already been destroyed. It is hoped rituximab can help lower the number of immune B cells in patients recently diagnosed with type 1 diabetes and prevent destruction of the remaining insulin producing beta cells. If this approach works, your diabetes will be easier to manage and cause you fewer problems later on.

Medicines that slow down the immune system have been used to treat other diseases. Rituximab is such a medicine. Its effects on the immune system are well understood. It is approved by the FDA for the treatment of a condition called B-lymphocyte lymphoma. Research has shown that it might be helpful in treating other conditions caused by T cells and B cells, including type 1 diabetes.

What will I be asked to do?

If you decide to be in the study, you will be randomly assigned to receive rituximab or receive a placebo (a pretend medicine that does nothing). The group you are assigned to is decided by chance (as by the toss of a coin or drawing straws). Neither you nor your doctor will be able to choose which group you are in. Also, neither you nor the researchers will know which group you are in.

Two out of three people will be assigned to the group taking rituximab. One out of three people will be assigned to the group taking the placebo. Working with two separate groups in this way allows researchers to compare and measure the benefits of taking rituximab to not taking rituximab.

You will take rituximab, or the placebo once a week during the first 4 weeks in the study. It will be given in your vein using an intravenous catheter (an IV) at a clinical center.

Afterwards, you will return to the clinical center for a visit about every 3 months for two years. At those visits, you'll have blood drawn for testing and you'll meet with a doctor. At 5 of the visits, you will take a longer test, called a Mixed Meal Tolerance Test. It requires an IV be put in your arm and you to drink a special protein drink. Then, blood samples will be taken from the IV over the next 2 to 4 hours.

Benefits

Researchers hope that rituximab will help protect your remaining beta cells and their ability to produce insulin. If researchers are right, your participation could lead to better blood sugar control and reduced risk of long-term, diabetes-related problems. Information gained from these studies may also help other people at risk for type 1 diabetes.

Participation

To see if you might be eligible for this study and for a referral to a TrialNet site:

The blood test to determine whether or not you are at risk for Type 1 Diabetes is part of the Natural History study. Please see the list of Clinical Centers for more information.

Information will be kept confidential.

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