Pain Clinical Trial
Official title:
Adalimumab (Anti TNF Alfa) in the Management of Acute Lumbar Disc Prolapses - a One Year, Randomized, Placebo Controlled, Double Blind, Single Center Trial
Verified date | October 2013 |
Source | Kuopio University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Finnish Medicines Agency |
Study type | Interventional |
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 type:
A one year,randomized, placebo controlled double blind single center trial.
Patients and study drug treatment:
The study population consist of 99 patients with sciatica caused by herniated disc prolapse.
The study has 3 arms: 33 patients randomized to adalimumab 40mg every week, 33 patients
randomized to adalimumab 40mg every other week, and 33 patients randomized to placebo. Study
drug treatment period will be six weeks.
Methods:
Clinical evaluation, global assessments and Oswestry Disability Score and visual analog
scale (VAS) will be used as the evaluation of clinical results with the disc prolapse
patients confirmed by Magnetic Resonance Imaging. Health related quality of life will be
assessed by 15-D questionnaire. Safety will be evaluated by medical examinations, adverse
events (AE) collection and laboratory measurements throughout the study period.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Kuopio University Hospital | Kuopio |
Lead Sponsor | Collaborator |
---|---|
Kuopio University Hospital |
Finland,
Cooper RG, Freemont AJ. TNF-alpha blockade for herniated intervertebral disc-induced sciatica: a way forward at last? Rheumatology (Oxford). 2004 Feb;43(2):119-21. Epub 2003 Sep 16. — View Citation
Cuellar JM, Montesano PX, Carstens E. Role of TNF-alpha in sensitization of nociceptive dorsal horn neurons induced by application of nucleus pulposus to L5 dorsal root ganglion in rats. Pain. 2004 Aug;110(3):578-87. — View Citation
Genevay S, Stingelin S, Gabay C. Efficacy of etanercept in the treatment of acute, severe sciatica: a pilot study. Ann Rheum Dis. 2004 Sep;63(9):1120-3. Epub 2004 Apr 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain | As primary endpoint the functionality of the patients measured by Oswestry Disability Score and VAS (leg and back pain) will be evaluated and the proportion of patients in each group for the need of surgery at week 6 at the end of the study drug injections. | one year | Yes |
Secondary | need for operative treatment and functional status = proportion of patients operated after one year | As secondary endpoints functionality of the patient, need of operative treatment, sick leave days and pain killer consumption will be evaluated at week 1, 2, 4 and 6, 3 months, 6 months and 12 months 1 year after the start of study treatment. | one year | Yes |
Secondary | safety in general | All patients who receive study medication will be included to the safety analysis. Blood tests before and after administration will be analysed. Vital signs and clinical examination will be recorded on each visits All adverse and serious adverse events will be evaluated in connection to study medication during the follow-up time. |
During one year follow up. | Yes |
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