ADALISKIAS: Adalimumab for Acute Disc Prolapse

Summary

Aims: To study the efficacy and safety of adalimumab versus placebo in the treatment of acute disc prolapse will be will be compared up to 12 months after the start of study drug treatment. Study type: A one year,randomized, placebo controlled double blind single center trial. Patients and study drug treatment: The study population consist of 99 patients with sciatica caused by herniated disc prolapse. The study has 3 arms: 33 patients randomized to adalimumab 40mg every week, 33 patients randomized to adalimumab 40mg every other week, and 33 patients randomized to placebo. Study drug treatment period will be six weeks. Methods: Clinical evaluation, global assessments and Oswestry Disability Score and visual analog scale (VAS) will be used as the evaluation of clinical results with the disc prolapse patients confirmed by Magnetic Resonance Imaging. Health related quality of life will be assessed by 15-D questionnaire. Safety will be evaluated by medical examinations, adverse events (AE) collection and laboratory measurements throughout the study period.

Timeline

Start

2007-03

Primary completion

2014-07

Completion

2014-07

Publications

• Background Cooper RG, Freemont AJ. TNF-alpha blockade for herniated intervertebral disc-induced sciatica: a way forward at last? Rheumatology (Oxford). 2004 Feb;43(2):119-21. doi: 10.1093/rheumatology/keh013. Epub 2003 Sep 16. No abstract available.
• Background Cuellar MJ, Montesano XP, Carstens E. Role of TNF-alpha in sensitization of nociceptive dorsal horn neurons induced by application of nucleus pulposus to L5 dorsal root ganglion in rats. Pain. 2004 Aug;110(3):578-587. doi: 10.1016/j.pain.2004.03.029.
• Background Genevay S, Stingelin S, Gabay C. Efficacy of etanercept in the treatment of acute, severe sciatica: a pilot study. Ann Rheum Dis. 2004 Sep;63(9):1120-3. doi: 10.1136/ard.2003.016451. Epub 2004 Apr 28.

Drugs

Indications