EUCTR2013-002777-22-DE进行中（未招募）1 期
Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA
niversity of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine0 个研究点目标入组 230 人开始时间: 2013年11月22日最近更新:
适应症
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
- 230
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. Patients fulfilling the ACR/EULAR classification criteria 2010 for RA
- •Patients must be:
- •2. Within the two years of starting on methotrexate AND
- •3. Within 5 years of diagnosis AND
- •4. a) In a stable clinical disease activity state (clinical remission/LDAS /other physician deemed state) for at least 8 successive weeks before screening visit (with no change in DMARD +/- steroid therapy)
- •b) On methotrexate (as monotherapy or combination +/- = prednisolone 5mg oral daily)
- •c) On an acceptable (maximal tolerated) methotrexate dose, which, in the clinician's opinion would justify escalation to adalimumab if a flare in disease activity occurs as detailed in the protocol
- •5. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Subjects must agree to use adequate contraception during the study and for at least 5 months after study completion (or longer if on relevant therapy and in line with local regulations). Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 5 months after the end of the study period.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients not on a stable dose of methotrexate within 8 weeks of screening, intolerance or contraindications (as per clinician judgment)
- •2. intra-articular or change in oral corticosteroid within 8 weeks of screening visit.
- •3. Oral Prednisolone dose > 5 mg within 8 weeks of screening
- •4. Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening.
- •5. Patients who have previously received any biological therapy for RA.
- •6. History of severe allergic or anaphylactic reactions to human, humanised or murine monoclonal antibodies
- •7. Evidence of serious +/- uncontrolled concomitant disease which in the investigator’s judgment would deem the patient inappropriate for inclusion in the study: including (but not exclusively) cardiovascular (NYHA class III/IV heart failure), nervous system (demyelination), pulmonary (including obstructive pulmonary disease, pulmonary fibrosis), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn’s disease.).
- •8. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, Hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
- •9. Any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. Patients with persistent infections and patients at significant risk of infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1 year (or ever if prosthetic joint still in situ).
- •10. Tuberculosis
- •a) Active tuberculosis (TB) requiring treatment within the previous 3 years. Patients previously treated for tuberculosis with no recurrence in 3 years are permitted.
- •b) Patients should be screened for latent TB (as per local guidelines) and, if positive, treated in line with local practice guidelines prior to commencing the study.
- •11. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.
- •12. Malignancy
- •Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including haematological malignancies and solid tumours, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years unless related to primary disease under investigation.
研究者
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