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Trial record 1 of 2 for:    Active, not recruiting, Completed, Enrolling by invitation, Suspended, Terminated, Withdrawn, No longer available, Temporarily not available, Approved for marketing, Unknown status Studies | Sciatica | Switzerland
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Adalimumab in Severe and Acute Sciatica (ASAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00470509
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : April 22, 2019
Information provided by (Responsible Party):
Stephane Genevay, University Hospital, Geneva

Brief Summary:
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 or disease Intervention/treatment Phase
Sciatica Drug: Adalimumab Drug: Placebos Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adalimumab in Severe and Acute Sciatica
Study Start Date : May 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica
Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Adalimumab
adalimumab (2 subcutaneous 40 mg injections on day 0 and 7)
Drug: Adalimumab
2 subcutaneous injections on day 0 and 7
Other Name: Humira

Placebo Comparator: Placebo
2 placebo injections on day 0 and 7
Drug: Placebos
2 subcutaneous injections on day 0 and 7
Other Name: placebo injection

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

Secondary Outcome Measures :
  1. delta VAS [ Time Frame: 6 months ]
    Percentage of amelioration for VAS and ODI (Oswestry Disability Index)

  2. SF-12 [ Time Frame: 6 months ]
    Assessment of patient's statisfaction and expectations using the SF12 general health questionnaire.

  3. delta ODI [ Time Frame: 6 months ]
    Percentage of amelioration for ODI (Oswestry Disability Index)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00470509

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Geneva University Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
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Principal Investigator: Stéphane Genevay, MD Geneva University Hospital & Swiss Society of Rheumatology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stephane Genevay, Dr, University Hospital, Geneva Identifier: NCT00470509    
Other Study ID Numbers: ASAS
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Anti-Inflammatory Agents
Antirheumatic Agents