ISRCTN21216199已完成3 期
Prospective randomised study assessing the efficacy of Tocilizumab with synovial analysis in patients with rheumatoid arthritis
niversity of Leeds (UK)0 个研究点目标入组 15 人开始时间: 2010年4月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
2016 abstract in: http://dx.doi.org/10.1136/annrheumdis-2016-eular.5304 (added 20/05/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects meeting all of the following criteria will be considered for enrolment into the study:
- •1. Male and female patients aged between 18 and 80 years
- •2. Diagnosis of rheumatoid arthritis (1987 revised American College of Rheumatology [ACR] criteria) confirmed at least 6 months prior to screening
- •3. Persistent RA disease activity with inadequate response whilst being treated with an anti-TNF agent for at least 12 weeks, or patients who have previously discontinued anti-TNF due to toxicity, or patients have previously qualified for anti-TNF (NICE/BSR criteria) but therapy is contra-indicated
- •4. Methotrexate dose stable for 12 weeks prior to screening and to be continued for the duration of the study
- •5. Subjects with active RA at baseline are defined as: Disease Activity Scale (DAS28) greater than 5.1
- •6. Patients on non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids must have remained on an unchanged regimen for at least 28 days prior to study drug administration
- •7. Patients must be able and willing to comply with the terms of this protocol including attending for arthroscopy and imaging assessments
- •8. Informed consent must be obtained in writing for all subjects at enrolment into the study
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Patients unwilling or unable to receive methotrexate for the duration of the study
- •2. Patients with inflammatory joint disease of different origin, mixed connective tissue disease, Reiter's syndrome, psoriatic arthritis, systemic lupus erythematosus, or any arthritis with onset prior to 16 years of age
- •3. Suspicion of diagnosis of tuberculosis (positive tuberculosis test (greater than 5 mm induration if previous BCG or greater than 10 mm if no previous BCG) or abnormal chest x-ray)
- •4. Patients with concomitant medical condition which would in the investigator's opinion compromise the patient's ability to tolerate, absorb, metabolise or excrete the study medication
- •5. Patients with serious infections within 3 month of enrolment (screening) or persistent infections
- •6. 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])
- •7. Patients with malignancy (other than excised basal cell carcinoma) within the last 5 years before study entry (screening)
- •8. Patients with history of Felty's syndrome, uncontrolled diabetes, uncontrolled hypertension, unstable ischaemic heart disease, active bowel disease, active peptic ulcer disease, recent stroke (within three month before study entry screening), or other condition which, in the opinion of the investigator, would put the patient at risk to participate in the study
- •9. Known positive serology for hepatitis B or C, or human immunodeficiency virus (HIV)
- •10. Discontinuation of a prohibited disease-modifying anti-rheumatic drug (DMARD) (e.g. oral or injectable gold, chloroquine, hydroxychloroquine, cyclosporine, azathioprine, leflunomide, sulphasalazine) or TNF-blocker (infliximab, etanercept or adalimumab) must occur at least 28 days prior to study drug administration (week 0)
- •11. Patients with acute major trauma
- •12. Patients with body weight less than 45 kg
- •13. Clinically relevant cardiovascular, hepatic, neurologic (such as multiple sclerosis, optic neuritis etc.), endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- •14. Impaired hepatic function, as shown by:
- •14.1. Alanine aminotransferase (ALT) or alkaline phosphatase (ALP) greater than or equal to 2 times the laboratory upper limit of normal
- •14.2. Serum albumin less than 30 g/l
- •15. Patients with significantly impaired bone marrow function as for example significant anaemia, leukopenia, neutropenia or thrombocytopenia as shown by the following laboratory values:
- •15.1. Haemoglobin less than 8.5 g/dl
- •15.2. Haematocrit less than 30%
- •15.3. Platelet count less than 100 x 10^9/L
- •15.4. White blood cell count less than 3.5 x 10^9/L
- •15.5. Neutrophils count less than 1 x 10^9/L
- •16. Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome or impaired renal function, as shown by:
- •16.1. Serum creatinine greater than 150 umol/L
- •16.2. Creatinine clearance greater than 50 ml/min
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