EUCTR2006-004673-98-HU进行中（未招募）不适用
Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker
Roche (Hungary) Ltd.0 个研究点目标入组 20 人开始时间: 2006年9月8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
- 20
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
- •Women or men 18 years of age or older
- •Diagnosis of RA according to the revised 1987 criteria of the ARA for at least 3 months prior to first administration of study medication
- •Inadequate response or intolerance to one or more anti-TNF-therapies alone or in combination with MTX
- •Wash out period for anti-TNF therapies: 4 weeks for etanercept, 8 weeks for infliximab and for adalimumab
- •Active disease at the time of screening as defined by:
- •- = 6 swollen on a 66/68 joint count
- •- = 6 tender joints on a 66/68 joint count
- •And one out of the following 3 categories:
- •- ESR = 28 mm/ h
- •- CRP = 1.5 mg/ dl
- •- Morning stiffness = 45 min
- •And one out of the following 2 categories:
- •-Anti-cyclic citrullinated peptide (Anti-CCP) antibody-positive
- •-Rheumatoid factor (RF)-positive at screening
- •If using NSAIDs or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent.
- •If using oral corticosteroids, must be on a stable dose equivalent to = 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 2 weeks prior to first administration of study medication.
- •Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent.
- •Female subjects of childbearing potential must test negative for pregnancy. A pregnancy test will be performed at the beginning and at the end of the study.
- •The screening laboratory test must meet the following criteria:
- •- Hemoglobin = 8.5 g/ dl providing the low hemoglobin level is not due to other diseases than anemia of chronic inflammation.
- •- WBC = 3500 / µl
- •- Neutrophils = 1500 / µl
- •- Platelets = 100 000 / µl
- •- Serum transaminase = 2 times the upper limit of normal
- •- Serum creatinine = 1.7 mg/ dl
- •The patient must be able to adhere the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
- •Patients who, in the opinion of the investigator, are able to understand and complete the questionnaires, are willing and able to comply with the protocol requirements;
- •Patients who have signed the 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant women, nursing mothers or a planned pregnancy within six months after last scheduled treatment.
- •Patients with other inflammatory diseases that might interfere with the evaluation of the RA.
- •Severe heart failure ( NYHA class IV) or severe, uncontrolled cardiac disease
- •Patients with fibromyalgia syndrome.
- •Use of IM, IV, IA cortocisteroids within 4 weeks prior to screening.
- •Treatment with any investigational drug within 3 months prior to screening.
- •A history of known allergy to murine proteins, e.g. allergy to Infliximab.
- •History of infected joint prothesis within the previous 5 years.
- •Chronic infections.
- •Known active bacterial, viral, fungal, mycobacterial or other infection (including tuberculosis, or atypical mycobacterial disease, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- •History of recurrent significant infection or history of recurrent bacterial infections.
- •Primary or secondary immunodeficiency (history of, or currently active).
- •Current signs or symptoms of other severe uncontrolled disease which in the investigators opinion would put the patient at an unacceptable risk.
- •History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin.
- •History of drug abuse.
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