The Rituximab Study
(This study is no longer recruiting patients)
Type 1 diabetes is an autoimmune disease. That means your immune system – there to protect you against potentially harmful outside substances – is mistakenly attacking your own insulin-producing cells. As these cells, called beta cells, are destroyed, you develop diabetes. This study is trying to see if it is possible to stop or slow down the immune system's attack in newly diagnosed type 1 diabetes patients so that the remaining beta cells can survive and keep making some of the insulin your body needs.
- Brief summary of study
- Why are researchers interested in rituximab?
- Who can be in the study?
- Who should not be in the study?
- What are the benefits of being in the study?
- Where can I find clinical centers who are recruiting?
Brief summary of 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.
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.
Why are researchers interested in rituximab?
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.
Who can be in the study?
All clinical trials have their own set of research study guidelines to help select the right type of patient for each study, i.e., those who can benefit most. Guidelines also help protect all study participants.
You can be in the rituximab study, if you:
- 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.
Who should not be in the study?
Guidelines for clinical studies also describe people who are not well suited for the study, in other words, those who would benefit least.
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.
What are the benefits of being in the study?
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.
Where can I find clinical centers who are recruiting?
If you wish to see if you might be eligible for this study, complete the online screening or call toll free anytime:
1- 800- HALT- DM1 (1-800-425-8361)
Or contact one of the participating clinical centers directly.
- Regional Area
- Participating Clinical Center
- Alaska, Idaho, Montana, Oregon, and Washington
-
Benaroya Research Institute at Virginia Mason
Seattle, WA
800-888-4187 - Colorado, Kansas, Missouri, Utah, and Wyoming
-
Barbara Davis Center for Childhood Diabetes
University of Colorado
Aurora, CO
800-572-3992 - Delaware, District of Columbia, Maryland, Ohio, Pennsylvania, Virginia, West Virginia and Southern New Jersey
-
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA
412-692-5210
Karen.Riley@chp.edu - Canada
-
The Hospital for Sick Children
Toronto, Ontario
866-699-1899 - New York and Northern New Jersey
-
Naomi Berrie Diabetes Center
Columbia University
New York, NY
212-851-5425
emg25@columbia.edu -
Indiana, Illinois, Kentucky and
Lower Peninsula Michigan -
Riley Hospital for Children
Indiana University
Indianapolis, IN
866-230-8486
pedsdiab@iupui.edu - Central California and Nevada
-
Stanford University Medical Center
Stanford, CA
877-232-5182
dwilson@stanford.edu - Northern California and Hawaii
-
University of California, San Francisco
San Francisco, CA
415-353-9084
kfraserh@ucsf.edu - Georgia, North Carolina, South Carolina, Tennessee, and Northern Florida
-
University of Florida
Gainesville, FL
800-749-7424, dial 1, Ext. 334-0857
cookrb@peds.ufl.edu
abraa@peds.ufl.edu - Alabama, Arkansas, Louisiana, Mississippi, Southern Florida, and Puerto Rico
-
University of Miami
School of Medicine
Miami, FL
305-243-3781 - Iowa, Minnesota, Nebraska, North Dakota, South Dakota, Wisconsin, and Upper Peninsula Michigan
-
University of Minnesota
Minneapolis, MN
800-688-5252, Ext. 58944
schmi094@umn.edu
pete5601@umn.edu - New Mexico, Oklahoma, and Texas
-
University of Texas
Southwestern Medical Center at Dallas
Dallas, TX
214-648-4844
marilyn.alford@utsouthwestern.edu
maria.pruneda@utsouthwestern.edu