To determine the efficacy of adalimumab in disc herniation-induced sciatica in a controlled randomised double blind pilot study. MedDRA version: 8.1 Level: LLT Classification code 10039674 Term: Sciatica
Conditions
Sponsors
Dr. Valérie gangji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 18 year and 30 mm 5. Oswestry Score > 20 6. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion: · condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for 3 months prior to study drug administration) · a vasectomized partner 7. Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol. 8. Subject must be able and willing to self-administer SC injections or has available qualified person(s) to administer SC injections. 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: 1. Symptoms of cauda equida syndrome 2. CT or MRI showed evidence of nerve root compression from causes other than a herniated nucleus pulposus 3. patient had received a corticosteroids epidural for the current episode in the preceding 90 days 4. allergy to local anaesthetics 5. previous low back surgery 6. work accident, out of work for more than one year 7. Medical history of tuberculosis. Positive PPD/intradermal reaction or an abnormal chest x-ray suggestive of active TB. 8. History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. 9. Immuno-compromised conditions or history of HIV. 10. History of listeriosis, history of histoplasmosis, active TB, persistent chronic or active infections requiring treatment with intravenous (iv) antibiotics, iv antivirals, or iv antifungals within 30 days or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to study entry 11. History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease 12. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. There should be at least a 150-day period between the last dose of study drug and either conception or initiation of breast-feeding in women of childbearing potential. 13. Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. 14. Investigational biological and chemical agents within 5 half-lives prior to Screening visit or within a longer or shorter time period depending on the mechanism of action. 15. History of clinically significant drug or alcohol abuse 16. The investigator considers the subject, for any reason, to be unacceptable for study participation. 17. Patient who has a known blood coagulation disorder 18. Medical history of demyelinating disease 19. Medical history of systemic lupus erythematosus 20. Presence of acute or chronic Hepatitis B or a history of Hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome will be: success or failure of the treatment at 1 week. The patient will perceived the overall degree of improvement or deterioration on a descriptive four item scale (recovery, marked improvement, slight improvement, or worse). The patient rating recovery or marked improvement will be considered as a success; and rating slight improvement or worse will considered as a failure. ;Secondary Objective: Secondary outcomes : VAS, Oswestry questionnaire ;Primary end point(s): The primary outcome will be: success or failure of the treatment at 1 week. The patient will perceived the overall degree of improvement or deterioration on a descriptive four item scale (recovery, marked improvement, slight improvement, or worse). The patient rating recovery or marked improvement will be considered as a success; and rating slight improvement or worse will considered as a failure. | — |
Countries
Belgium
Outcome results
None listed