EUCTR2013-002611-96-ES进行中（未招募）不适用
Pilot study to determine the efficacy of anakinra (antagonist of interleukin-1 receptor) administered for 3 months in improving inflammatory signs observed by MRI in patients with erosive/inflammatory hand osteoarthritis.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •-Patients over 18 years at the moment of the selection visit.
- •-Patients with erosive osteoarthritis of the interphalangeal joints with significant clinical activity acording to Anandarajah criteria.
- •- Important functional repercussions despite the conventional treatment reflected with a score 24 or more on the AUSCAN questionaire.
- •- Patients who can understand the study implications thus they are able to give the written informed consent.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Related to the study
- •-Pregnant or breast-feeding.
- •-Women of childbearing potential and sexually active not compliant with adequate contraceptive measures during the study.
- •-Participation in any clinical investigation within 3 months prior to drug administration
- •-Patients with scheduled surgery during the study.
- •-History of drug abuse.
- •-Patients with any restrictions related to the NMR test
- •Related to the medical history:
- •-History of malignancy within the last five years.
- •-Fibromyalgia and / or chronic fatigue syndrome.
- •-Uncontroled cardiovascular disease.
- •-Clinical history of inflammatory or systemic diseases.
- •-Secondary osteoarthritis such as chondrocalcinosis, Paget's disease, aseptic osteonecrosis, gout, ochronosis, acromegaly, hemochromatosis, Wilson's disease and osteochondromatosis
- •-More intense pain in other part of the body that could interfere with the evaluation.
- •-Poorly controlled diabetes mellitus, defined by a hemoglobin A1c>8%(25).
- •-History of immunosuppression.
- •-Acute or chronic infections requiring antibiotic treatment or serious fungal or viral infections (eg hepatitis, herpes zoster, HIV)
- •-Major defects of clotting.
- •-Active gastrointestinal disease.
- •-Acute or chronic liver disease
- •-Acute or chronic kidney disease with levels of blood urea nitrogen (BUN) or serum creatinine 2 times ULN or CrCl <30 ml / min at the screening visit.
- •-History of significant medical conditions, which in the opinion of the investigator would preclude the patient from participating in this trial
- •Related to the treatments:
- •-Patients taking corticosteroids (oral or injectable), methotrexate, hydroxychloroquine or SYSADOA 12 weeks prior to inclusion.
- •-Patients who have used intra-articular hyaluronic acid (in the hand of study) during the 24 weeks prior to the enrollment visit.
- •-Patients undergoing radioactive synoviorthesis (in the hand of study)
- •-Patients who have received any live virus vaccine within 12 weeks prior to starting the study (also not be allowed during the trial, including the 3 months following the last dose of study medication)
- •-Patients treated with other bDMARDs (Biological Disease Modifying Anti-Rheumatic Drugs)
- •-Patients treated with oral anticoagulants.
- •-Patients with known hypersensitivity to any component of the study drugs.
- •-Patients who have experienced asthma, urticaria or allergic reactions after administration of acetylsalicylic acid or NSAIDs.
研究者
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