Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04474847 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Abatacept for the Treatment of Giant Cell Arteritis

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 9 to 10v15
  2. Study sites: 8 to 9v14
  3. Start date: Mar 15, 2021 to Mar 29, 2021v13
  4. Primary and study completion dates: Dec 2026 to Dec 2029 Study sites: 7 to 8v12 Show 1 more changeShow less
    • Study sites: 7 to 8
  5. Trial status: Active, Not Recruiting to Recruiting Site details revised at 7 of 7 sitesv11 Show 1 more changeShow less
    • Site details revised at 7 of 7 sites
Show 9 earlier versionsHide 9 earlier versions
  1. 2 versions Re-verified since Jun 12, 2023, no change to tracked fieldsv9-v10
  2. Study sites: 6 to 7v8
  3. Primary and study completion dates: Dec 2024 to Dec 2026 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 6 of 6 sitesv7 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
  4. Study sites: 3 to 6v6
  5. Study sites: 1 to 3v5
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2021 to Mar 15, 2021 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2021 to Mar 15, 2021
    • Site details revised
  7. Start date: Nov 2020 to Mar 2021v3
  8. Start date: Aug 2020 to Nov 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped. Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.
Trial Details
NCT Number NCT04474847
Lead Sponsor University of Pennsylvania
Conditions Giant Cell Arteritis
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov