Status:
UNKNOWN
ADALISKIAS: Adalimumab for Acute Disc Prolapse
Lead Sponsor:
Kuopio University Hospital
Conditions:
Disc Prolapse
Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Aims: To study the efficacy and safety of adalimumab versus placebo in the treatment of acute disc prolapse will be will be compared up to 12 months after the start of study drug treatment. Study ty...
Detailed Description
Aims of this study: TNF alpha is believed to have a major role in the pathogenesis of sciatica. The efficacy and safety of adalimumab versus placebo in the treatment of acute disc prolapse will be wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Males and females over 18 years of age
- Able and willing to give written informed consent
- Acute or subacute (no more than 2 months) clinical sciatica symptoms caused by herniated disc prolapse confirmed by Magnetic Resonance Imaging (MRI).
- Oswestry Disability Score at least 16% at entry.
- VAS (leg and back pain) at least 40 mm at entry.
- Able and willing to self-administer s.c. injections or have available a suitable person to administer s.c. injections.
- A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.
- Exclusion criteria:
- Prior treatment with any investigational agent within 30 days, or five half lives of the product whichever is longer.
- Prior treatment with infliximab or etanercept.
- History of chronic back pain.
- Previously operated disc prolapse or other spinal column operation
- Uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III-IV), recent stroke (within three months), chronic leg ulcer and any other condition (e.g. indwelling urinary catheter) which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- History of cancer or malignant lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- Positive serology for hepatitis B or C indicating active infection.
- History of positive HIV status.
- Persistent or recurrent infections or severe infections requiring hospitalization or treatment with i.v. antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
- Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g. optic neuritis, ataxia, apraxia).
- History of active tuberculosis, histoplasmosis or listeriosis.
- Female subjects who are pregnant or breast-feeding.
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01510548
Start Date
March 1 2007
End Date
July 1 2014
Last Update
October 11 2013
Active Locations (1)
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1
Kuopio University Hospital
Kuopio, Finland, 70210