Adalimumab (anti TNF alfa) in the management of acute lumbar disc prolapses -a one year, randomized, placebo controlled, double blind, single center trial

• Conditions: Patients with acute or subacute (no more than 2 months) clinical sciatica caused by herniated disc prolapse; MedDRA version: 8.1Level: LLTClassification code 10036852Term: Prolapsed lumbar disc

• Registration Number: EUCTR2006-003564-57-FI
• Lead Sponsor: Kuopio University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-males and females over 18 years old
-acute or subacute (no more than 2 months) clinical sciatica symptoms caused by herniated disc prolapse confirmed by MRI
-Oswestry Disability Score at least 16%
-VAS (leg and back pain) at least 40 mm
-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
-able and willing to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-prior treatment with any investigational agent within 30 days, or 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 3-4), 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-metastic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of cervix
-positive serology for hepatitis B or C indicating active infection
-history of active tuberculosis, histoplasmosis or listeriosis
-previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g. optic neuritis, ataxia, apraxia)
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified