Adalimumab in Severe and Acute Sciatica

NCT00470509 | Completed Phase 2

• 1 other identifier: ASAS
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Sciatica

Outcome Measures

Primary Outcomes (1)

• Leg pain

  Evolution of leg pain over time. Pain will be assessed using a Visual Analog Scale (VAS).

  6 months

Secondary Outcomes (3)

• delta VAS

  6 months

• SF-12

  6 months

• delta ODI

  6 months

Study Arms (2)

Adalimumab

EXPERIMENTAL

adalimumab (2 subcutaneous 40 mg injections on day 0 and 7)

Drug: Adalimumab

Placebo

PLACEBO COMPARATOR

2 placebo injections on day 0 and 7

Drug: Placebos

Interventions

Adalimumab DRUG

2 subcutaneous injections on day 0 and 7

Also known as: Humira

Adalimumab

Placebos DRUG

2 subcutaneous injections on day 0 and 7

Also known as: placebo injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients older than 18
• Episode of radicular pain in one lower limb for less than 12 weeks.
• Medical evaluation requiring hospitalisation because of pain or functional handicap
• 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.
• Oswestry score greater than 50
• If there is a past history of radicular pain involving the same nerve root, a 6 months interval free of leg pain is required.
• 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.
• Written informed consent

You may not qualify if:

• 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.
• 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.
• Pregnancy.
• History of intolerance to adalimumab or any of its ingredients
• Previous participation in this clinical study.
• Participation in another clinical study within 4 weeks prior to the start of or during this study.
• Poor motivation or other emotional or intellectual problems that are likely to limit the ability of the patient to comply with the protocol requirements.
• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1211, Switzerland

Location

Related Publications (1)

• Genevay S, Viatte S, Finckh A, Zufferey P, Balague F, Gabay C. Adalimumab in severe and acute sciatica: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Aug;62(8):2339-46. doi: 10.1002/art.27499.

  PMID: 20506391 DERIVED

MeSH Terms

Conditions

Sciatica

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stéphane Genevay, MD

  Geneva University Hospital & Swiss Society of Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: May 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

CH (1)