Download What will happen in this study? Most visits

Study Name: Janssen CNTO148DML2001
Study Sponsors: Janssen Research & Development, LLC
Principal Investigator: Leonard Chuck, PhD, MD
Who is eligible: Type 1 Diabetes diagnosed within 100 days of first drug dose in patients aged 6-21
Volunteers must have lab values related to recent onset diabetes, full age-appropriate immunization
Volunteers cannot have any of the following conditions: Other autoimmune diseases, known allergies
to human immunoglobulin proteins, golimumab or any of its components or excipients, live virus or
bacterial vaccination 90 days before study drug administered
What is this study about? To determine whether golimumab, a monoclonal antibody against TNFά,
can preserve beta-cell function in children and young adults with recently diagnosed Type 1
Diabetes Mellitus
What will happen in this study? Most visits consist of physical exam, vitals, lab draw and study drug
administration; 4 visits include an extended stay of 5 hours on site to assess residual beta cell function
How long will this study last? The study lasts 2 years: Treatment in the first year but observation in the
second year when there are only 2 visits to our facility in Walnut Creek
Reimbursement: $100-$250 per visit for the participant; $70 per visit for the caregiver if an adult
accompanies the under 18 patients to the visits
For more information, please contact: Leonard Chuck 925-930-7267 X231
Participant's rights questions, contact: Sterling Institutional Review Board Regulatory Department, 6300
Powers Ferry Road, Suite 600-351, Atlanta, GA 30339 or 1-888-636-1062 (toll free).