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Trial of Belimumab in Early Lupus

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Aug 2026 to Sep 2028 Completion date: Dec 2026 to Mar 2029v12 Show 1 more changeShow less
    • Completion date: Dec 2026 to Mar 2029
  2. Primary completion date: Aug 2025 to Aug 2026 Completion date: Dec 2025 to Dec 2026v11 Show 1 more changeShow less
    • Completion date: Dec 2025 to Dec 2026
  3. Primary completion date: Nov 2022 to Aug 2025 Completion date: Jan 2023 to Dec 2025 · Eligibility criteria expanded, about 9 wordsv10 Show 2 more changesShow less
    • Completion date: Jan 2023 to Dec 2025
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv9
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2020 to Sep 15, 2020 · Site details revisedv8 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2020 to Sep 15, 2020
    • Site details revised
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Mar 2020 to Sep 2020v7
  2. Start date: Aug 2019 to Mar 2020v6
  3. Start date: Jun 2019 to Aug 2019v5
  4. Start date: Apr 2019 to Jun 2019v4
  5. Start date: Aug 2018 to Apr 2019v3
  6. Start date: May 2018 to Aug 2018v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Northwell Health
133 trials monitored
See 10 trials at risk
Lupus (SLE)
651 trials monitored
See 25 trials at risk
This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.
Trial Details
NCT Number NCT03543839
Lead Sponsor Northwell Health
Collaborators: GlaxoSmithKline
Conditions Lupus Erythematosus, Systemic, Lupus Erythematosus
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov