Lumbar Spinal Fibrosis and TNF Alpha Inhibition

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Publications: details revised at 1 of 1 entry
    • Collaborators expanded, about 5 words
    v6
  2. Study completion date changed from estimate of Jun 2013 to Dec 2014
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 40 to confirmed 38
    v5
  3. Primary completion date changed from estimate of Sep 2012 to Oct 2012
    • Study completion date: Jan 2013 to Jun 2013
    v4
  4. Trial status: Recruiting to Active, Not Recruitingv3 Show 6 more changesShow less
    • Primary completion date: Sep 2012
    • Study completion date: Nov 2008 to Jan 2013
    • Interventions: TNF blocker (Drug) to Placebo (Drug), TNF blocker (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Study arms: 0 to 2
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2006 to Feb 2007
    • Site details revised
    v2
  6. Study First Submitted
  • 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.
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
Trial Details
NCT Number NCT00385086
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions
(from sponsor)		 Post Operative Sciatica by Lumbar Spinal Fibrosis
Related terms Fibrosis, Pain, Sciatica
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov