ISRCTN18262002已完成未知
Investigating relationships between IL-17, Th17 pathway activation and therapeutic response to TNF inhibition in rheumatoid arthritis patients: an observational cohort study
Queen Mary University of London (UK)0 个研究点目标入组 50 人开始时间: 2015年8月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Men and women = 18 and = 65 years of age, with RA as defined by the 2010 revised EULAR/ACR classification criteria
- •2. An RA diagnosis as defined by the 2010 revised EULAR/ACR classification criteria
- •3. Subjects who fulfill the NICE guidelines for biologic therapy as their first-line treatment following failure of standard disease modifying anti-rheumatic therapy
- •4. Subjects may be on cDMARDs of which one must be MTX, or on MTX monotherapy, but should be receiving it for at least 2 months, with a stable dose of 7.525 mg/week for a minimum of 4 weeks
- •5. Subjects may be on oral steroids (prednisone =10 mg/day, or equivalent corticosteroid) with a stable dose for the 4 weeks prior to Visit 0
- •6. Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) for the duration of the study
- •7. Patient must be able to adhere to the study visit schedule
- •8. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures
- •9. Must have a chest X-ray within 3 months prior to commencement of anti-TNF therapy with no evidence of malignancy, infection or fibrosis
- •Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years
排除标准
- •1. Women who are pregnant or breastfeeding
- •2. Previous use of rheumatoid arthritis anti-TNF biologics, or ANY other type of biologic therapy or investigational medicinal product
- •3. Treatment with any other therapeutic agent targeted at reducing TNF within 3 months of screening
- •4. Serious infections (such as, HIV, HBV, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator
- •5. Have active TB or have evidence of latent TB (old or latent TB on chest x-ray,without adequate therapy for TB initiated prior to first dose of study drug). Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy. Patients with a current close contact with an individual with active TB and patients who have completed treatment for active TB within the previous 2 years are explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrolment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies
- •6. Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening)
- •7. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
- •8. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly
- •9. Known recent substance abuse (drug or alcohol)
- •10. Poor tolerability of venepuncture required blood sampling during the study period
- •11. Planning to have surgery for RA or other significant surgery during the period of study
研究者
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