Adalimumab (Anti TNF Alfa) in the Management of Acute Lumbar Disc Prolapses - a One Year, Randomized, Placebo Controlled, Double Blind, Single Center Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
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.
详细描述
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 will be compared up to 12 months after the start of study drug treatment. Primary objective of the study is to evaluate the clinical functionality of the patients with Oswestry Disability Score and VAS (leg and back pain) at the end of study drug treatment at week 6. Secondary objectives are to compare the need of operative treatment, sick leave days, pain killer consumption and quality of life between the two study groups up to 12 months after the start of study drug treatment.
Patients and study drug treatment:
The study population consist of 99 patients with sciatica caused by herniated disc prolapse. The patients will be randomized to 3 arms: 33 patients to adalimumab 40mg every week, 33 patients to adalimumab 40mg every other week, and 33 patients to placebo. Study drug treatment period will be six weeks.
The study population will be collected from the patient population with severe sciatica symptoms sent to Spine Unit of Department of Physical and Rehabilitation Medicine in Kuopio University Hospital. The patient information will be given orally by investigators at the first visit and also patient information letter will be given. The informed consent will be signed by the patient and the investigator before any study related procedures. Patient will receive a copy of the written information and signed informed consent form. The patient has the right to discontinue his participation at any time without giving any reason.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain
时间窗: one year
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.
次要结局
- need for operative treatment and functional status = proportion of patients operated after one year(one year)
- safety in general(During one year follow up.)
研究者
olavi airaksinen
MD, PhD Ass Proff, Head of the Department of Rehabilitation
Kuopio University Hospital