Patients with acute or subacute (no more than 2 months) clinical sciatica caused by herniated disc prolapse MedDRA version: 8.1 Level: LLT Classification code 10036852 Term: Prolapsed lumbar disc
Conditions
Interventions
Trade Name: Humira 40 mg injektioneste, liuos esitäytetyssä kertakäyttöruiskussa
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Concentration unit: mg milligram(s)
Concent
Sponsors
Kuopio University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy and safety of adalimumab vs placebo in the treatment of acute disc prolapse compared up to 12 months after the start of the study drug treatment.;Secondary Objective: ;Primary end point(s): The functionality of the patients measured by Oswestry Disability Score and VAS (leg and back pain). Secondary endpoints: Functionality of the patient, need of operative treatment, sick leave days and pain killer consumption. | — |
Countries
Finland
Outcome results
None listed