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A Phase 3 Study Comparing TLL-018 to Tofacitinib in RA Subjects With Inadequate Response or Intolerance to bDMARDs

Study acronym: TARA
StatusCompleted
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Study completion date changed from estimate of Dec 31, 2026 to Aug 20, 2026
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 7 of 7 entries
  2. Primary completion moved earlier from Jul 31, 2026 to Jan 15, 2026
    • Study completion moved earlier from Dec 30, 2028 to Dec 31, 2026
    v5
  3. Primary completion date: Feb 28, 2025 to Jul 31, 2026v4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 450 to 459
    • Study completion date: Sep 30, 2025 to Dec 30, 2028
    • Eligibility criteria revised
    • Site details revised
  4. Start date changed from estimate of Nov 30, 2023 to Nov 15, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 30, 2023 to Nov 30, 2023
    • Site details revised
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A randomized, double-blind, double-dummy, positive-controlled, phase 3 study to assess the safety and efficacy of TLL-018 in active rheumatoid arthritis subjects who had an inadequate response or intolerance to Biologic DMARDs.
Trial Details
NCT Number NCT06020144
Lead Sponsor Hangzhou Highlightll Pharmaceutical Co., Ltd
Conditions
(from sponsor)		 Rheumatoid Arthritis
Related terms Arthritis, Rheumatoid
Enrollment 459 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov