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Sponsored by: |
University Hospital, Geneva |
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Information provided by: | University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT00470509 |
The purpose of this study is to determine whether adalimumab (a TNF-alpha inhibitor) is effective in the treatment of severe and acute sciatica.
Condition | Intervention | Phase |
---|---|---|
Sciatica |
Drug: adalimumab (2 subcutaneous 40 mg injections on day 0 and 7) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Adalimumab in Severe and Acute Sciatica |
Enrollment: | 61 |
Study Start Date: | May 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Sciatica and low back pain are common problems that lead to major costs in Western countries. The presence of herniated disc is generally considered as the leading cause of sciatica. However, recent findings indicate that the presence of this mechanism is not sufficient to explain all the clinical signs of radiculopathy and that inflammatory mechanisms contribute also to the pathophysiology of sciatica. Indeed, herniated discs contain large amounts of tumor necrosis factor (TNF-alpha) which can induce acute and chronic inflammation and pain. It has recently been demonstrated that TNF-alpha inhibitors (infliximab or etanercept) were able to prevent the occurrence of pain in an experimental model of sciatica. In addition, two independent preliminary studies have shown that patients treated with TNF-alpha inhibitors had better evolution than an historical control group. This study has been designed to verify the hypothesis that TNF-alpha has a major role in human sciatica and that anti-TNF-alpha agents are interesting therapeutic approaches in severe sciatica.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients presenting a characteristic leg pain in the L3, L4, L5, or S1 territories plus at least one of the following: :
clear clinical sign of nerve root involvement
Exclusion Criteria:
The presence of recent (<48 hours) severe muscle weakness (<3/5) or clinical signs of cauda equina compression, requiring immediate surgery.
Comorbidities such as :
The investigators will also be allowed to exclude an individual patient from the study and remove the blinding in case of a superimposed infection or any severe side effect during the trial.
Switzerland | |
Geneva University Hospital | |
Geneva, Switzerland, 1211 |
Principal Investigator: | Stéphane Genevay, MD | Geneva University Hospital & Swiss Society of Rheumatology |
Study ID Numbers: | ASAS |
Study First Received: | May 4, 2007 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00470509 |
Health Authority: | Switzerland: Swissmedic |
Sciatica Signs and Symptoms Neuromuscular Diseases Neuralgia Peripheral Nervous System Diseases |
Neurologic Manifestations Pain Adalimumab Mononeuropathies |
Anti-Inflammatory Agents Sciatic Neuropathy Therapeutic Uses |
Nervous System Diseases Antirheumatic Agents Pharmacologic Actions |