Adalimumab in Severe and Acute Sciatica (ASAS)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00470509
First received: May 4, 2007
Last updated: June 6, 2008
Last verified: June 2008
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Adalimumab in Severe and Acute Sciatica

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Evolution of leg pain over time. Pain will be assessed using a Visual Analog Scale (VAS). [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Percentage of amelioration for VAS and ODI (Oswestry Disability Index) [ Time Frame: 6 months ]
  • Assessment of patient's statisfaction and expectations using the SF12 general health questionnaire. [ Time Frame: 6 months ]

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients older than 18
  2. Episode of radicular pain in one lower limb for less than 12 weeks.
  3. Medical evaluation requiring hospitalisation because of pain or functional handicap
  4. Patients presenting a characteristic leg pain in the L3, L4, L5, or S1 territories plus at least one of the following: :

    • positive straight-leg-raising test with an elevation of less than 70°
    • positive femoral stretched
    • clear clinical sign of nerve root involvement

      • muscle strength deficiency or
      • sensory disturbances in clear cut dermatome or
      • lower limb reflex asymmetry.
  5. Oswestry score greater than 50
  6. If there is a past history of radicular pain involving the same nerve root, a 6 months interval free of leg pain is required.
  7. A confirmed herniated disc on usual imaging techniques (CT scan or MRI) in the vicinity of the clinically involved nerve root that has been performed within the last 2 years.
  8. Written informed consent

Exclusion Criteria:

  1. The presence of recent (<48 hours) severe muscle weakness (<3/5) or clinical signs of cauda equina compression, requiring immediate surgery.

    • If surgical procedure is required but is denied, either because of surgeon's decision or because of patient's fully informed decision, then this patient could be included in the protocol.
  2. Comorbidities such as :

    • Coexisting infections (Chest X-ray will be performed to all patients and tuberculin skin test in case of doubt concerning a past history of tuberculous infection).
    • Autoimmune disease (other than RA).
    • History of cancer or malign lymphoproliferative disorders (unless the patient has been declared in remission for more than 5 years)
    • History of demyelinating disorders.
  3. Pregnancy.
  4. History of intolerance to adalimumab or any of its ingredients
  5. Previous participation in this clinical study.
  6. Participation in another clinical study within 4 weeks prior to the start of or during this study.
  7. Poor motivation or other emotional or intellectual problems that are likely to limit the ability of the patient to comply with the protocol requirements.
  8. The use of cortisone prior to the inclusion IS NOT an exclusion criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470509

Locations
Switzerland
Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Stéphane Genevay, MD Geneva University Hospital & Swiss Society of Rheumatology
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00470509     History of Changes
Other Study ID Numbers: ASAS
Study First Received: May 4, 2007
Last Updated: June 6, 2008
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014