EUCTR2007-003994-18-NL进行中（未招募）不适用
EHOA: Etanercept as treatment for Hand OsteoArthritisA randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy and the structure modifying properties of etanercept 50/25 mg subcutaneous weekly in patients with eroive osteoarthritis of the interphalangeal finger joints - EHOA
eiden University Medical Center0 个研究点目标入组 90 人开始时间: 2007年10月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •Males and females > 18 years of age. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 30 days after the last dose of test article.
- •Subjects with hand OA showing or having suffered from transient inflammatory attacks of the IPJs characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA.
- •At least 4 OA nodes of the IPJs, e.g. Heberden's and Bouchard's nodes at screening
- •At least 1 inflamed IP (slight swelling or erythema) at screening
- •At least 1 IP with positive power Doppler signal at ultrasound
- •Subjects with hand OA in which at least 1 IPJ has the typical appearance on radiograph of an E” phase joint as defined by the criteria mentioned above.
- •OA pain at rest at screening visit of > 30 mm on the VAS
- •Flare of OA pain with activity at baseline (after NSAID washout) as defined by: >50mm on the VAS
- •Worsening by > 20 mm on the VAS compared to screening
- •Use of NSAIDs to treat finger joint pain at least 5 days per week with a stable dose for at least 4 weeks
- •Inadequate response to at least 1 NSAIDS other than the current NSAID.
- •Able and willing to self-administer sc injections or have available a suitable person to administer sc 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
- •Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer.
- •Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis or positive rheumatoid factor or positive anti-CCP antibodies, spondylarthropathy, psoriatic arthritis, haemochromatosis, gout, chondrocalcinosis or other auto-immune diseases
- •Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, corticosteroids, tetracyclines and estrogens is allowed.
- •Prior use of any immunomodulating drug with possible effects on pro-inflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, d-penicillamin, anti-malarials, cytotoxic drugs, TNF blocking agents
- •If the patient is of child-bearing age, he/she must use effective means of contraception during the study.
- •Patient who has a known blood coagulation disorder
- •History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia, with no recurrence within the last two years
- •Comorbidities: 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.
- •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 iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
- •Female subjects who are breast-feeding.
- •History of clinically significant drug or alcohol abuse in the last year.
- •Previous diagnosis or signs of central nervous system demyelinating diseases (e.g., optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).
- •Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis
- •Evolutive tuberculosis or other severe infections like sepsis and opportunistic infections
- •Patients with latent TB (positive PPD skin and/or chest X-ray indicative for TB) or having other risk factors for activation of latent TB, e.g. previous exposure to TB, who have not initiated a TB prophylaxis prior to the first etanercept treatment.
- •Current or prior history of blood dyscrasias. Abnormal safety baseline blood test e.g. hemoglobin =85 g/L; hematocrit =27 %; platelet count =125 x 109 /L; white blood cell count =3.5 x 109 /L; serum creatinine =175 µmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) =2 times the laboratory’s upper limit of normal.
- •Pre-existing or recent onset CNS demyelinating disease.
- •Uncontrolled conditions, e.g., diabetes mellitus, hypertension (defined as screening systolic blood pressure > 160mm Hg or screening diastolic blood pressure > 100 mm Hg), severe pulmonary disease requiring hospitalization or supplemental oxygen.
- •Latex sensitivity.
- •Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements or
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