ISRCTN49682259已完成未知
Remission Induction in Very Early Rheumatoid Arthritis: a comparison of etanercept plus methotrexate plus steroid with standard therapy
Record Provided by the NHSTCT Register - 2007 Update - Department of Health0 个研究点目标入组 20 人开始时间: 2007年9月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •Patients with very early synovitis of less than 12 week duration will be identified via the rapid access early arthritis clinics run at the participating centres. Patients fulfilling clinical inclusion criteria and not meeting exclusion criteria will have measurements of their serum levels of rheumatoid factor and anti-CCP antibody and will be given an information sheet on the study. They will be asked to attend for follow up review after 2-7 days. Those patients who are seropositive for both rheumatoid factor and anti-CCP antibody will be invited to participate in the trial.
- •1. Age over 18 years
- •2. Synovial swelling of at least 1 joint confirmed by clinical assessment
- •3. Seropositivity for RF and anti-CCP Ab
- •4. 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
- •5. Female subjects of childbearing potential must test negative for pregnancy
- •6. Patients should be able to give informed consent to study entry
排除标准
- •1. Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of >1 hour) of >12 weeks
- •2. Previous history of inflammatory arthritis
- •3. Previous use of DMARDs or anti-TNF-agents
- •4. Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders)
- •6. A history or other evidence of latent or active granulomatous infection, including TB, histoplasmosis or coccidioidomycosis, prior to study entry
- •7. 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
- •8. 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
- •9. Known infection with HIV, hepatitis B, or hepatitis C
- •10. A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent
- •11. 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, heart failure, history of demyelinating disease such as multiple sclerosis or optic neuritis)
- •12. Bleeding disorder or the use of anti-coagulants
- •13. 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)
- •14. Any contraindication to etanercept, methotrexate or parenteral depomedrone
研究者
相似试验
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 - RIVERAEUCTR2006-001428-38-GBniversity Hospitals Birmingham NHS Foundation Trust20
尚未招募
4 期
Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanerceptrheumatoid arthritisJPRN-C000000452Johoku Biological Summit50
已完成
不适用
Remission induction in early rheumatoid arthritis.Observational study.NL-OMON20139/A200
进行中（未招募）
1 期
REMission INDuction in very early Rheumatoid ArthritisEUCTR2015-004858-17-NLniversity Medical Center Utrecht (UMCU)267
已完成
4 期
REMission INDuction in very early Rheumatoid ArthritisRAArthritis10013361NL-OMON47431niversitair Medisch Centrum Utrecht267