EUCTR2006-005426-23-DK进行中（未招募）不适用
Evaluation of the efficacy and safety of adalimumab (Humira) s.c. injections eow. in patients with adhesive capsulitis (frozen shoulder). - The TEST Trial
Pierre Schydlowsky0 个研究点开始时间: 2006年11月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The diagnosis of adhesive capsulitis. Pain and stiffness of the shoulder predominantly for 3 weeks or more. Restriction of passive motion by more than 30 degrees in 2 or more planes. Age over 18 years. Pain defined as defined as a Constant score less or equal to 20 in Subjective assessment of Pain (maximum score 35). A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment. [Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)]Use of reliable method of contraception e.g. intra-uterine devices or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential during the entire study and 150 days after cessation of study medication. Able and willing to self-administer s.c. injections or have available a suitable person to administer s.c. injections. Able and willing to give written informed consent and to comply with the requirements of the study protocol.
- •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
排除标准
- •Positive serology for hepatitis B or C indicating active infection. History of positive HIV status, tuberculosis, histoplasmosis or listeriosis. Subjects with latent TB (positive PPD skin test and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB. Persistent or recurrent infections or severe infections requiring hospitalisation or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrolment. History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma or cervical dysplasia. Co morbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III-IV), active inflammatory bowel disease, 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. Female subjects who are pregnant or breastfeeding. History of clinically significant drug or alcohol abuse in the last year. History of or current acute or chronic inflammatory joint disease of origin other than adhesive capsulitis, e.g. radiological evidence of osteoarthritis of the glenohumeral joint on X-ray, ultrasonographic evidence of complete rotatorcuff tear. Previous diagnosis or signs of central nervous system demyelinating diseases (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia)
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