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

Study acronym: TN25
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Feb 17, 2026, no change to tracked fieldsv18-v19
  2. Primary completion date: Mar 2027 to Mar 31, 2027 Completion date: Mar 2029 to Mar 31, 2029v17 Show 1 more changeShow less
    • Completion date: Mar 2029 to Mar 31, 2029
  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Oct 2027 to Mar 2027 · Completion date: Oct 2029 to Mar 2029 · Eligibility criteria expanded, about 68 words · 1 morev16 Show 4 more changesShow less
    • Primary completion date: Oct 2027 to Mar 2027
    • Completion date: Oct 2029 to Mar 2029
    • Eligibility criteria expanded, about 68 words
    • Site details revised at 19 of 19 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 18 to 19 Eligibility criteria expanded, about 24 wordsv15 Show 1 more changeShow less
    • Eligibility criteria expanded, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  5. Eligibility criteria expanded, about 4 wordsv14 See this version in full on ClinicalTrials.gov ↗
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 14 to 18v13
  2. Study sites: 12 to 14v12
  3. Study sites: 9 to 12v11
  4. Start date changed from estimate of Nov 2023 to Oct 30, 2023v10
  5. Trial status: Suspended to Recruiting Enrollment target: 36 to 74 · Primary completion date: Apr 30, 2026 to Oct 2027 · Start date: Feb 17, 2020 to Nov 2023 · 10 morev9 Show 13 more changesShow less
    • Enrollment target: 36 to 74
    • Primary completion date: Apr 30, 2026 to Oct 2027
    • Start date: Feb 17, 2020 to Nov 2023
    • Primary endpoints: 5 to 1
    • Study sites: 7 to 9
    • Completion date: Apr 30, 2027 to Oct 2029
    • Interventions: Abatacept (Drug), Rituximab (Drug) to Abatacept (Drug), Rituximab-pvvr (Drug), Sterile Sodium Chloride (Drug)
    • Eligibility criteria expanded, about 274 words
    • Secondary endpoints: 17 to 2
    • Study description expanded, about 92 words
    • Collaborators: 2 to 1
    • Study arms: 1 to 2
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Jul 2025 to Apr 30, 2026 Completion date: Jul 2026 to Apr 30, 2027v8 Show 1 more changeShow less
    • Completion date: Jul 2026 to Apr 30, 2027
  7. Trial status: Recruiting to Suspended Sponsor's reason: Enrollment suspended by Sponsor. Site details revised at 7 of 7 sitesv7 Show 1 more changeShow less
    • Site details revised at 7 of 7 sites
  8. Study sites: 3 to 7v6
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Mar 1, 2020 to Feb 17, 2020v5 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Mar 1, 2020 to Feb 17, 2020
  10. Start date: Oct 2019 to Mar 1, 2020v4
  11. Start date: Jul 1, 2019 to Oct 2019v3
  12. Secondary endpoints: details revised at 2 of 17 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.
Trial Details
NCT Number NCT03929601
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: National Institutes of Health (NIH)
Conditions Type 1 Diabetes Mellitus
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov