Back to resultsRituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes (TN25)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Abatacept
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Participant in TrialNet Pathway to Prevention Study (TN01).
- Age ≥ 8 years old at time of enrollment in this trial
- Participant (or parent or legal guardian if the participant is a minor) is willing to provide Informed Consent.
- Individuals <18 years of age at time of enrollment must have had a TrialNet-conducted OGTT demonstrating abnormal glucose tolerance within 7 weeks (52 days) of the baseline visit (visit 0).
- Individuals ≥18 years of age at time of enrollment must have had two consecutive TrialNet conducted OGTTs demonstrating abnormal glucose tolerance, the most recent of which must have been within 7 weeks (52 days) of the baseline visit (visit 0).
- The participant must be positive for two or more diabetes-related autoantibodies on two occasions. The second occasion must occur within the six months prior to study drug administration, but does not need to involve the same two autoantibodies as were found on the first occasion. The autoantibodies that are to be confirmed are anti-GAD65, anti-ICA512, anti-insulin (MIAA), ZnT8 and/or ICA.
- Weigh at least 20 kg.
- If participant is female with reproductive potential, she must have a negative pregnancy test at screening be willing to avoid pregnancy for duration of the treatment period.
- Willing to forego other forms of experimental treatment during the study.
- Willing and medically acceptable to postpone live vaccine immunizations for 3 months after treatment.
Exclusion Criteria:
- Diabetes
- Immunodeficient or have clinically significant chronic lymphopenia
- Require use of other immunosuppressive agents
- Chronic active infection other than localized skin infections.
- Active infection at the time of infusion.
- A positive PPD or Quantiferon test, or history of previous treatment for TB.
- Vaccination with a live virus within 4 weeks prior to enrollment.
- Vaccination with a killed virus within 4 weeks prior to enrollment.
- A history of confirmed infectious mononucleosis within the 3 months prior to enrollment, as documented by EBV serology.
- Not up-to-date on current immunizations
- Laboratory or clinical evidence of acute infection with EBV or CMV, either via serology or PCR.
- Serological evidence of current or past HIV, Hepatitis B or Hepatitis C infection.
- Be currently pregnant or lactating, or anticipate getting pregnant within 2 years and 4 months of enrollment
- Chronic use of steroids or other immunosuppressive agents.
- Known and untreated hypothyroidism or active Graves' disease at enrollment.
- Administration of a monoclonal antibody within the year before enrollment.
- History of malignancy.
- Use of exogenous insulin or any other anti-hyperglycemic drugs.
- Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant.
- Have severe obesity: adults BMI ≥ 40; children BMI-z score ≥ 2.0.
Sites / Locations
- University of California - San Francisco
- Stanford University
- University of Florida
- Indiana University - Riley Hospital for Children
- University of Minnesota
- University of Pittsburgh
- Benaroya Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab followed by Abatacept
Arm Description
Rituximab will be given by IV infusion over a 3-8 hour period, at a dose of 375mg/m2 on four visits each one week apart, starting at Week 1 of the study. Abatacept will be given by a subcutaneous formulation weekly for 2 years, beginning at Week 16 (Month 4) of the study. Dosing will be determined by weight: Up to 25 kg: 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL).
Outcomes
Primary Outcome Measures
Assessment of Insulin Production during course of study
The insulin data gathered from regular monitoring of glucose tolerance will be used to measure changes in insulin secretion.
Assessment of C-peptide during course of study
The C-peptide data gathered from regular monitoring of glucose tolerance will be used to measure changes in insulin secretion.
Assessment of Glucose Tolerance Status to Evaluate Progression to Stage 3 Type 1 Diabetes
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine the glucose levels in the blood. Changes in blood glucose levels will be utilized to measure the progression to Stage 3 type 1 diabetes throughout the study.
Assessment of Glucose Tolerance Status to Evaluate Reversal to Normal Glucose Tolerance
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine the glucose levels in the blood. Changes in blood glucose levels will be utilized to measure reversal to normal glucose tolerance throughout the study.
Assessment of Insulin Production (post-diagnosis)
For those participants that progress to stage 3 Type 1 Diabetes during the course of this trial, a Mixed Meal Tolerance Test (MMTT) will be performed at six month intervals. C-peptide and Insulin data from the MMTT will be used to measure insulin criteria.
Secondary Outcome Measures
Assessment of the Incidence of Treatment-Emergent Adverse Events of rituximab followed by Abatacept in this Population, as Assessed by CTCAE criteria
Incidence of Treatment-Emergent Adverse Events will be assessed throughout the course of the study by using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Assessment of the Proportion of Subjects who End Treatment Due to Adverse Reactions, as Assessed by CTCAE criteria.
The proportion of subjects who end treatment due to adverse reactions will be assessed throughout the course of the study by using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Effect of Rituximab followed by Abatacept on the reversal of dysglycemia as defined by reversion to a normal OGTT
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine if glucose reverses to normal levels.
Effect of Rituximab followed by Abatacept on the reversal of dysglycemia as defined by the duration of normoglycemia
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine duration of normoglycemia.
Effect of Rituximab followed by Abatacept on changes in C-peptide secretion levels.
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine c-peptide secretion levels.
Effect of Rituximab followed by Abatacept on changes in insulin secretion levels.
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine insulin secretion levels.
Effect of Rituximab Followed by Abatacept on Changes in B-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Disease Activity
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in B-Cell response.
Effect of Rituximab Followed by Abatacept on Changes in T-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Disease Activity
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in T-Cell response.
Effect of Rituximab Followed by Abatacept on Changes in B-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Identification of Surrogate Immune Markers that Correlate with and May Predict Clinical Response
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in B-Cell response.
Effect of Rituximab Followed by Abatacept on Changes in T-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Identification of Surrogate Immune Markers that Correlate with and May Predict Clinical Response
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in T-Cell response.
Assessment of the Presence of Previous Autoimmune Disease within the Participant's Family, as Assessed by the Past Medical History Questionnaire
Presence of previous autoimmune disease within the participant's family will be assessed throughout the course of the study by using participant and/or parent/guardian responses to the Past Medical History Questionnaire. The Past Medical History Questionnaire will utilize a set of fourteen dichotomous questions to determine the presence of previous autoimmune disease within the participant's family. The choices will range from "yes" or "no". If they choose "yes" to one of the answers, the participants will also enter a qualitative free-response to specify which relative has been previously diagnosed (i.e. Parent, Child, Sibling, Half-Sibling, Grandparent, Grandchild, Aunt/Uncle, Cousin, Niece/Nephew). This questionnaire is utilized to obtain medical history; thus, questionnaire outcomes will not be defined as better or worse for the purposes of the assessment. Subscales will not be combined to compute a total score.
Assessment of the Concentration of Participant's Abnormalities to Body Systems, as Assessed by the Past Medical History Questionnaire
Body system abnormalities will be assessed throughout the course of the study by using participant and/or parent/guardian responses to the Past Medical History Questionnaire. The Past Medical History Questionnaire will utilize a set of thirteen dichotomous questions to determine the concentration of participant's abnormalities to body systems. The choices will range from "Normal" or "Abnormal". If the questionnaire author chooses "Abnormal" to one of the answers, a qualitative free-response to specify why the body system was deemed abnormal will need to be entered. This questionnaire is utilized to obtain medical history; thus, questionnaire outcomes will not be defined as better or worse for the purposes of the assessment. Subscales will not be combined to compute a total score.
Assessment of participant's height to determine safety
Safety of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Assessment of participant's height to determine tolerability
Tolerability of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Assessment of participant's weight to determine safety
Safety of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Assessment of participant's weight to determine tolerability.
Tolerability of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Assessment of the Number of Concomitant Medications, as Assessed by the Past Medical History Questionnaire
The number of concomitant medications the participant is consuming will be assessed throughout the course of the study by using participant and/or parent/guardian responses to the Past Medical History Questionnaire.
Full Information
NCT ID
NCT03929601
First Posted
May 16, 2018
Last Updated
April 13, 2022
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institutes of Health (NIH), Juvenile Diabetes Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03929601
Brief Title
Rituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes
Acronym
TN25
Official Title
Rituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Why Stopped
Enrollment suspended by Sponsor.
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institutes of Health (NIH), Juvenile Diabetes Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is a clinical trial testing sequential therapy with rituximab followed by abatacept in individuals destined to develop clinical type 1 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
The arm for this study is experimental. It consists of a rituximab dose followed by an abatacept dose. Rituximab will be given by IV infusion over a 3-8 hour period, at a dose of 375mg/m2 on four visits each one week apart, starting at Week 1 of the study. Abatacept will be given by a subcutaneous formulation weekly for 2 years, beginning at Week 16 (Month 4) of the study. Dosing will be determined by weight: Up to 25 kg: 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL).
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rituximab followed by Abatacept
Arm Type
Experimental
Arm Description
Rituximab will be given by IV infusion over a 3-8 hour period, at a dose of 375mg/m2 on four visits each one week apart, starting at Week 1 of the study.
Abatacept will be given by a subcutaneous formulation weekly for 2 years, beginning at Week 16 (Month 4) of the study. Dosing will be determined by weight: Up to 25 kg: 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL).
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Participants will receive Rituximab dosing from Week 1 to Week 4 of the trial. Rituximab will be given by IV infusion over a 3-8 hour period, at a dose of 375mg/m2 on four visits each one week apart.
Intervention Type
Drug
Intervention Name(s)
Abatacept
Intervention Description
Participants will receive initial Abatacept dosing at Week 16 of trial. Abatacept will be given by a subcutaneous (SC) formulation weekly for two years, and dosing be will determined according to weight: Up to 25 kg: 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL). Abatacept treatment will continue for full 24-month period regardless of whether participants have progressed to stage 3 type 1 diabetes during treatment.
Primary Outcome Measure Information:
Title
Assessment of Insulin Production during course of study
Description
The insulin data gathered from regular monitoring of glucose tolerance will be used to measure changes in insulin secretion.
Time Frame
Collected during initial study visit and during Visit Months 4, 8, 12, 18, 24, 30, and 36.
Title
Assessment of C-peptide during course of study
Description
The C-peptide data gathered from regular monitoring of glucose tolerance will be used to measure changes in insulin secretion.
Time Frame
Collected during initial study visit and during Visit Months 4, 8, 12, 18, 24, 30, and 36.
Title
Assessment of Glucose Tolerance Status to Evaluate Progression to Stage 3 Type 1 Diabetes
Description
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine the glucose levels in the blood. Changes in blood glucose levels will be utilized to measure the progression to Stage 3 type 1 diabetes throughout the study.
Time Frame
Collected during initial study visit and during Visit Months 4, 8, 12, 18, 24, 30, and 36
Title
Assessment of Glucose Tolerance Status to Evaluate Reversal to Normal Glucose Tolerance
Description
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine the glucose levels in the blood. Changes in blood glucose levels will be utilized to measure reversal to normal glucose tolerance throughout the study.
Time Frame
Collected during initial study visit and during Visit Months 4, 8, 12, 18, 24, 30, and 36
Title
Assessment of Insulin Production (post-diagnosis)
Description
For those participants that progress to stage 3 Type 1 Diabetes during the course of this trial, a Mixed Meal Tolerance Test (MMTT) will be performed at six month intervals. C-peptide and Insulin data from the MMTT will be used to measure insulin criteria.
Time Frame
Individuals who develop stage 3 diabetes will undergo MMTT at 6 and 12 months after diagnosis.
Secondary Outcome Measure Information:
Title
Assessment of the Incidence of Treatment-Emergent Adverse Events of rituximab followed by Abatacept in this Population, as Assessed by CTCAE criteria
Description
Incidence of Treatment-Emergent Adverse Events will be assessed throughout the course of the study by using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Assessment of the Proportion of Subjects who End Treatment Due to Adverse Reactions, as Assessed by CTCAE criteria.
Description
The proportion of subjects who end treatment due to adverse reactions will be assessed throughout the course of the study by using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Effect of Rituximab followed by Abatacept on the reversal of dysglycemia as defined by reversion to a normal OGTT
Description
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine if glucose reverses to normal levels.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Effect of Rituximab followed by Abatacept on the reversal of dysglycemia as defined by the duration of normoglycemia
Description
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine duration of normoglycemia.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Effect of Rituximab followed by Abatacept on changes in C-peptide secretion levels.
Description
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine c-peptide secretion levels.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Effect of Rituximab followed by Abatacept on changes in insulin secretion levels.
Description
An Oral Glucose Tolerance test (OGTT) will be performed approximately every 4-6 months during this trial, or more frequently if clinically indicated, to determine insulin secretion levels.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Effect of Rituximab Followed by Abatacept on Changes in B-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Disease Activity
Description
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in B-Cell response.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Effect of Rituximab Followed by Abatacept on Changes in T-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Disease Activity
Description
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in T-Cell response.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Effect of Rituximab Followed by Abatacept on Changes in B-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Identification of Surrogate Immune Markers that Correlate with and May Predict Clinical Response
Description
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in B-Cell response.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Effect of Rituximab Followed by Abatacept on Changes in T-Cell Response, as Assessed by Mechanistic Assessments, Characteristic of Identification of Surrogate Immune Markers that Correlate with and May Predict Clinical Response
Description
Mechanistic assessments, including RNA, plasma, serum, DNA, and measures of B and T cell number and function, will be performed approximately every 2-4 months during this trial up to 36 months, to identify changes in T-Cell response.
Time Frame
Assessed during initial study visit and assessment period continues for up to 36 months.
Title
Assessment of the Presence of Previous Autoimmune Disease within the Participant's Family, as Assessed by the Past Medical History Questionnaire
Description
Presence of previous autoimmune disease within the participant's family will be assessed throughout the course of the study by using participant and/or parent/guardian responses to the Past Medical History Questionnaire. The Past Medical History Questionnaire will utilize a set of fourteen dichotomous questions to determine the presence of previous autoimmune disease within the participant's family. The choices will range from "yes" or "no". If they choose "yes" to one of the answers, the participants will also enter a qualitative free-response to specify which relative has been previously diagnosed (i.e. Parent, Child, Sibling, Half-Sibling, Grandparent, Grandchild, Aunt/Uncle, Cousin, Niece/Nephew). This questionnaire is utilized to obtain medical history; thus, questionnaire outcomes will not be defined as better or worse for the purposes of the assessment. Subscales will not be combined to compute a total score.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Assessment of the Concentration of Participant's Abnormalities to Body Systems, as Assessed by the Past Medical History Questionnaire
Description
Body system abnormalities will be assessed throughout the course of the study by using participant and/or parent/guardian responses to the Past Medical History Questionnaire. The Past Medical History Questionnaire will utilize a set of thirteen dichotomous questions to determine the concentration of participant's abnormalities to body systems. The choices will range from "Normal" or "Abnormal". If the questionnaire author chooses "Abnormal" to one of the answers, a qualitative free-response to specify why the body system was deemed abnormal will need to be entered. This questionnaire is utilized to obtain medical history; thus, questionnaire outcomes will not be defined as better or worse for the purposes of the assessment. Subscales will not be combined to compute a total score.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Assessment of participant's height to determine safety
Description
Safety of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Assessment of participant's height to determine tolerability
Description
Tolerability of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Assessment of participant's weight to determine safety
Description
Safety of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Assessment of participant's weight to determine tolerability.
Description
Tolerability of sequential therapy will be assessed for consideration of outcome measurement for the duration of the study.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
Title
Assessment of the Number of Concomitant Medications, as Assessed by the Past Medical History Questionnaire
Description
The number of concomitant medications the participant is consuming will be assessed throughout the course of the study by using participant and/or parent/guardian responses to the Past Medical History Questionnaire.
Time Frame
Collected during initial study visit and collection period continues for up to 36 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant in TrialNet Pathway to Prevention Study (TN01).
Age ≥ 8 years old at time of enrollment in this trial
Participant (or parent or legal guardian if the participant is a minor) is willing to provide Informed Consent.
Individuals <18 years of age at time of enrollment must have had a TrialNet-conducted OGTT demonstrating abnormal glucose tolerance within 7 weeks (52 days) of the baseline visit (visit 0).
Individuals ≥18 years of age at time of enrollment must have had two consecutive TrialNet conducted OGTTs demonstrating abnormal glucose tolerance, the most recent of which must have been within 7 weeks (52 days) of the baseline visit (visit 0).
The participant must be positive for two or more diabetes-related autoantibodies on two occasions. The second occasion must occur within the six months prior to study drug administration, but does not need to involve the same two autoantibodies as were found on the first occasion. The autoantibodies that are to be confirmed are anti-GAD65, anti-ICA512, anti-insulin (MIAA), ZnT8 and/or ICA.
Weigh at least 20 kg.
If participant is female with reproductive potential, she must have a negative pregnancy test at screening be willing to avoid pregnancy for duration of the treatment period.
Willing to forego other forms of experimental treatment during the study.
Willing and medically acceptable to postpone live vaccine immunizations for 3 months after treatment.
Exclusion Criteria:
Diabetes
Immunodeficient or have clinically significant chronic lymphopenia
Require use of other immunosuppressive agents
Chronic active infection other than localized skin infections.
Active infection at the time of infusion.
A positive PPD or Quantiferon test, or history of previous treatment for TB.
Vaccination with a live virus within 4 weeks prior to enrollment.
Vaccination with a killed virus within 4 weeks prior to enrollment.
A history of confirmed infectious mononucleosis within the 3 months prior to enrollment, as documented by EBV serology.
Not up-to-date on current immunizations
Laboratory or clinical evidence of acute infection with EBV or CMV, either via serology or PCR.
Serological evidence of current or past HIV, Hepatitis B or Hepatitis C infection.
Be currently pregnant or lactating, or anticipate getting pregnant within 2 years and 4 months of enrollment
Chronic use of steroids or other immunosuppressive agents.
Known and untreated hypothyroidism or active Graves' disease at enrollment.
Administration of a monoclonal antibody within the year before enrollment.
History of malignancy.
Use of exogenous insulin or any other anti-hyperglycemic drugs.
Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant.
Have severe obesity: adults BMI ≥ 40; children BMI-z score ≥ 2.0.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Greenbaum
Organizational Affiliation
Type 1 Diabetes TrialNet
Official's Role
Study Chair
Facility Information:
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Indiana University - Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Benaroya Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.trialnet.org/
Description
Related Info
Learn more about this trial
Rituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes
We'll reach out to this number within 24 hrs