Lumbar Spinal Fibrosis and TNF Alpha Inhibition

Phase 3 Completed 38 enrolled Assistance Publique - Hôpitaux de Paris URC-CIC Paris Descartes Necker Cochin · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start: 2007-02
Primary completion: 2012-10
Completion: 2014-12

Outcome

Missed primary endpoint

paper At day 10, the placebo and IFX groups did not differ in the primary outcome PMID 26596627 ↗

paper 50 % reduction in sciatica pain observed in three (17.6 %) versus five (27.8 %) patients; p = 0.69 PMID 26596627 ↗

Publications

Results Nguyen C, Palazzo C, Grabar S, Feydy A, Sanchez K, Zee N, Quinquis L, Ben Boutieb M, Revel M, Lefevre-Colau MM, Poiraudeau S, Rannou F. Tumor necrosis factor-alpha blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study. Arthritis Res Ther. 2015 Nov 19;17:330. doi: 10.1186/s13075-015-0838-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	3 mg/kg	Intravenous