EUCTR2012-004089-16-AT进行中（未招募）不适用
The effect of the interleukin-1 receptor antagonist Anakinra in patients with osteoarthritis of the hand: The AHOA (Anakinra in hand osteoarthritis) pilot study - The AHOA (Anakinra in hand osteoarthritis) pilot study
niversitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie, Medizinische Universität Wien0 个研究点开始时间: 2013年3月6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
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
- •A subject will be eligible for study participation if he/she meets the following criteria:
- •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.
- •Persistent or transient pain/aching at more than 3 days a week in at least one DIP and/or PIP joint with or without bony swelling
- •Hand X-ray showing alterations typical for OA
- •If NSAIDs are used to treat finger joint pain dosage must be stable for at least 4 weeks
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •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, seronegative spondylarthropathy, haemochromatosis, gout, chondrocalcinosis or other auto-immune diseases
- •Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, 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, she must use effective means of contraception during the study.
- •Use of anticoagulants (cumarins or low-molecular-weight-heparins)
- •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.
- •Patient who has a known blood coagulation disorder
- •History of cancer or lymphoproliferative disease
- •Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), recent stroke (within three months), uncontrolled hypertension (defined as screening systolic blood pressure > 160 mmHg or screening diastolic blood pressure > 100 mmHg), severe pulmonary disease requiring hospitalization or supplemental oxygen
- •Impaired renal function (CL Cr <30 ml/minute)
- •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.
- •Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis
- •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 give informed consent.
研究者
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