EUCTR2006-001428-38-GB进行中（未招募）1 期
Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA
niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2006年9月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- •1. Age over 18 years
- •2. Synovial swelling of at least 1 joint confirmed by clinical assessment
- •3. Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of < 12 weeks.
- •4. Seropositivity for RF and anti-CCP Ab
- •5. 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.
- •6. Female subjects of childbearing potential must test negative for pregnancy
- •In addition,
- •1. All subjects must have provided written informed consent prior to admission to the study.
- •2. The subject must be able to understand and comply with the protocol requirements, instructions and restrictions.
- •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
- •1. Previous history of inflammatory arthritis.
- •2. Previous use of DMARDs or anti-TNF-agents.
- •3. Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders).
- •4. Clinical evidence of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to study entry.
- •5. Administration, or expected administration, of any live virus or bacterial vaccination within 3 months before the first administration of study agent, or during the trial.
- •6. A history of an infected joint prosthesis, or administration of antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced.
- •7. Known infection with HIV, hepatitis B, or hepatitis C.
- •8. A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent.
- •9. Serious and uncontrolled co-existing disease that in the opinion of the investigator preclude the use of TNF-blocking medication, methotrexate or depomedrone (including pulmonary disease on chest radiograph, congestive cardiac failure (NYHA grade 3 or 4), history of demyelinating disease such as multiple sclerosis or optic neuritis).
- •10. Bleeding disorder of the use of anti-coagulants
- •11. Any known malignancy or a history of malignancy within the previous 5 years (with the exception of a basal cell carcinoma that has been treated with no evidence of recurrence).
- •12. Any other contraindication to etanercept, methotrexate or parenteral depomedrone.
- •13. Patients will also be excluded with the following laboratory results: haemoglobin <8.5 gm/dl, total white cell count <3.5 x 109/litre, serum transaminase value more than twice the upper limit of normal, and serum creatinine >150 micromoles/litre.
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