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Co-stimulatory Blockade

Rituximab + Abatacept for Type 1 Diabetes (TN25 Trial)

Phase 2

Recruiting

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Positive for at least one islet cell autoantibody: GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A

Body weight must be ≥ 20.0 kg for study agent administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, month 2, 4, 5, 6, 12, 13, 18, 24, 25, 30, and 36

Awards & highlights

TN25 Trial Summary

This trial will test if Abatacept can improve diabetes (T1D) response when used after Rituximab-pvvr. Primary outcome is C-peptide response 24 months after enrollment.

Who is the study for?

This trial is for people aged 8-45 with new onset Type 1 Diabetes who have certain levels of C-peptide, are positive for specific autoantibodies, and meet other health criteria. They must be up to date on vaccinations, not pregnant or planning pregnancy soon, willing to use contraception and follow intensive diabetes management.Check my eligibility

What is being tested?

The study compares the effect of Rituximab-pvvr followed by Abatacept versus Rituximab-pvvr alone on C-peptide response in newly diagnosed Type 1 Diabetes patients. It's a double-blinded trial where participants don't know which treatment they're getting.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to immune system suppression, potential liver enzyme elevations, and general symptoms like headache or nausea.

TN25 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My body has antibodies related to diabetes.

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My body weight is at least 20 kg.

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I am up to date with all my vaccinations.

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I am between 8 and 45 years old.

TN25 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, month 2, 4, 5, 6, 12, 13, 18, 24, 25, 30, and 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, month 2, 4, 5, 6, 12, 13, 18, 24, 25, 30, and 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, month 2, 4, 5, 6, 12, 13, 18, 24, 25, 30, and 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

C-Peptide Response to 2-hr MMTT at 24 months post-randomization

Secondary outcome measures

Analysis of changes in immune responses to known diabetes antigens and a neoantigen over time by treatment group

C-peptide AUC Means

TN25 Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Rituximab-pvvr followed by AbataceptActive Control2 Interventions

Rituximab-pvvr 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 0 of the study. Abatacept will be given by a subcutaneous formulation weekly for 20 months, 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).

Group II: Rituximab-pvvr followed by PlaceboPlacebo Group2 Interventions

Rituximab-pvvr 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 0 of the study. Placebo will be given by a subcutaneous isotonic saline formulation weekly for 20 months, beginning at Week 16 (Month 4) of the study. Dosing will be match to active comparator, determined by weight: Up to 25 kg: 0.4 mL; 25 to <50 kg rec 0.7 mL, and > 50 kg receive 1.0 mL.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,314,518 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,776 Total Patients Enrolled

Juvenile Diabetes Research FoundationOTHER

232 Previous Clinical Trials

141,710 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the upper age limit for this clinical trial greater than 85 years?

"The parameters for this clinical trial necessitate that participants must be aged 8 to 45. Notably, there are 218 trials available for minors and 951 specifically designed for individuals over 65."

Answered by AI

What is the scope of enrollment for this clinical trial?

"This trial necessitates the participation of 74 suitable patients. People living in and around San Francisco, California or New Haven, Connecticut may find it easy to join as University of California San Francisco and Yale Univeristy are both recruiting participants."

Answered by AI

What number of medical institutions are presently conducting this clinical trial?

"The University of California San Francisco, Yale University and the Children's Mercy Hospital are among the 15 medical facilities participating in this clinical trial. The other locations span across various US states."

Answered by AI

Is the trial still open for participants?

"Confirmed, according to clinicaltrials.gov this medical trial is open for recruitment as of today's date. It was first made available on November 1st 2023 and the most recent update was performed on October 30th 2023."

Answered by AI

To what extent is the combination of Rituximab-pvvr and Abatacept considered safe for individuals?

"With safety data but no efficacy evidence in Phase 2 trials, the Rituximab-pvvr and Abatacept combination has been rated a two by our team at Power."

Answered by AI

What criteria must be met for individuals to qualify as participants in this trial?

"This clinical trial seeks 74 participants between 8 and 45 years old with type 1 diabetes. To qualify, the individual must have already participated in TrialNet Pathway to Prevention Study (TN01), be willing to sign an informed consent form if they are a minor, have had two consecutive abnormal OGTT's within 7 weeks of baseline visit 0, test positive for at least 2 diabetes-related autoantibodies on two separate occasions within 6 months prior to study drug administration, weigh no less than 20kgs, women of reproductive potential must take a pregnancy test and abstain from conception during treatment period as well as forego any other experimental treatments"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes

2023. "Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03929601.

All > Type 1 Diabetes