CompletedPhase 2

Adalimumab in Severe and Acute Sciatica

Switzerland61 participantsStarted 2005-05

Plain-language 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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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: :
✓. 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

✕. The presence of recent (\<48 hours) severe muscle weakness (\<3/5) or clinical signs of cauda equina compression, requiring immediate surgery.
✕. Comorbidities such as :
✕. 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 use of cortisone prior to the inclusion IS NOT an exclusion criteria

Leg pain

Timeframe: 6 months

NCT IDNCT00470509

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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: :
✓. 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

✕. The presence of recent (\<48 hours) severe muscle weakness (\<3/5) or clinical signs of cauda equina compression, requiring immediate surgery.
✕. Comorbidities such as :
✕. 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 use of cortisone prior to the inclusion IS NOT an exclusion criteria