||Inducing Remission in New Onset T1DM with Alefacept (Amevive®)
||National Institute of Allergy and Infectious Disease (NIAID) and the Immune Tolerance Network (ITN)
||Steven Willi, MD, Director of the Diabetes Center at CHOP
Who can participate?
New onset type 1 diabetes, within 100 days of diagnosis
- 12 to 35 years of age
- Show positive results for at least one diabetes-related antibody
- Still making a minimum amount of insulin
- In good general health
What is this study about?
The purpose of this research study is to see if alefacept will slow or halt the progression of Type 1 Diabetes Mellitus in newly diagnosed individuals and to learn more about its safety. Alefacept is a drug that subdues the immune system. It is currently approved by the FDA to treat adults for an autoimmune skin disorder called psoriasis.
What does participation involve?
If you decide that you want to determine if you qualify for this study, you will be scheduled to come to the research clinic at CHOP for a screening visit where you can expect:
- Interviews about you medical history
- Physical examination
- Blood and urine samples collection for testing
Eligible volunteers who consent to participate will be randomly assigned to one of two groups. One group will be given the study drug, alefacept, and the other group will receive an inactive substance made to look like the study drug, called a placebo. Neither you nor the study physicians or nurses will know to which group you have been assigned. There is no guarantee that alefacept will work, or that you will receive the active drug (rather than the placebo).
Participants will receive a total of 24 weekly intramuscular injections of either alefacept or placebo:
- Cycle 1 (12 weeks) – clinic visit once a week + alefacept / placebo
- Pause (12 weeks) – clinic visit once a month
- Cycle 2 (12 weeks) – clinic visit once a week + alefacept / placebo
- Follow-up (15 months) – clinic visits once every 6 months
Regardless of whether you receive the experimental treatment or placebo, all participants will receive intensive diabetes management from expert medical staff, with the goal to keep blood glucose as close to normal as possible, thus enhancing your overall care.
How long will this study last?
Total clinical trial participation will last about 2 years.
Is there any payment?
Participants will be compensated for their time and reimbursed for travel and related expenses. Study-related care and study-related diabetes supplies will be provided at no cost to you.
For more information please visit ClinicalTrials.gov and Immune Tolerance Network.
If interested please email firstname.lastname@example.org or call: 267-426-7519.
CHOP IRB#: 11-008125
Approval Date: 5/27/2011
Expiration Date: N/A