EUCTR2010-020744-35-IT进行中（未招募）不适用
A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 900
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
- •For inclusion in the study subjects should fulfil the following criteria: 1. Provision of informed consent, prior to any study-specific procedures. NB: Patients agreeing to participate in the optional exploratory biomarker and/or exploratory genetic research must provide a separate informed consent. 2. Male or female aged 18 and over with a diagnosis of RA after the age of 16 according to the revised (1987) criteria of the American College of Rheumatology (see Appendix E for criteria). NB: Women of childbearing potential may be included only if using acceptable contraceptive methods (see Appendix H for definitions). All females must have 2 negative pregnancy tests, at least 14 days apart, prior to randomisation. 3. Active RA defined as: ? ?4 swollen joints and ?4 tender/painful joints (from 28 joint count) and either: ? ESR =28 mm/h, or ? CRP =10 mg/L. 4. At least 1 of the following: ? Documented history of positive rheumatoid factor ? Current presence of rheumatoid factor ? Radiographic erosion within 12 months prior to enrolment ? Presence of serum anti-cyclic citrullinated peptide antibodies (anti CCP). 5. Treatment with 1 of the following traditional DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine. NB: Those patients taking methotrexate should have been treated for at least 6 months prior to randomisation and with a stable dose between 7.5 mg and 25 mg per week for at least 6 weeks prior to randomisation. Those patients taking sulfasalazine should have had a stable dose for at least 6 weeks prior to randomisation. Those patients taking hydroxychloroquine or chloroquine should have had a stable dose for at least 12 weeks prior to randomisation. Patients receiving the lower doses of methotrexate (7.5 mg and 10 mg) should be doing so as a result of a documented history of intolerance to higher doses of methotrexate.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Females who are pregnant or lactating. 2. Any systemic inflammatory conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. 3. American College of Rheumatology functional Class IV or wheelchair/bed-bound. 4. Uncontrolled or poorly controlled hypertension defined as =140 mmHg systolic and/or =90 mmHg diastolic at baseline (Visit 2) with or without current anti hypertensive treatment. 5. Absolute neutrophil count (ANC) <1500/mm3 or 1.5 x 109/L. 6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.2 x upper limit of normal (ULN), or bilirubin >1.2 x ULN. 7. History of liver function abnormality requiring investigation, drug induced liver injury, chronic liver disease, excessive alcohol consumption or chronic alcohol induced disease. 8. Evidence of recent or significant CV disease 9. Evidence of active or recent infection including: ? Positive serological test for hepatitis B or hepatitis C (patients may be included if confirmed hepatitis C recombinant immunoblot assay negative or hepatitis C virus RNA negative [qualitative]), or patients with suspected human immunodeficiency virus (HIV). ? Treatment with intravenous antibiotics within previous month prior to randomisation, oral antibiotics within 2 weeks prior to randomisation or current evidence of a clinically significant active infection. 10. Evidence of tuberculosis (TB) infection. 11. Patients who have failed to respond to treatment with a TNF-? antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra. Patients who responded to treatment but where treatment was stopped for other reasons are allowed. Patients who have used anakinra or a TNF-? antagonist should have a minimum washout of 8 weeks prior to randomisation. 12. Patients who have previously been treated with other biologic agents including rituximab, abatacept and tocilizumab. 13. Use of any DMARDs other than methotrexate, sulfasalazine, hydroxychloroquine or chloroquine within 28 days prior to Visit 1, eg, leflunomide, azathioprine, cyclosporine, gold, penacillamine, minocycline or doxycycline. Any patient that has received leflunomide within 12 weeks prior to randomisation must have completed a cholestyramine washout prior to study randomisation. 14. Intramuscular, intravenous or intra-articular steroid injection within 6 weeks prior to randomisation. 15. Patients requiring doses of oral steroids >10 mg/day prednisolone (or equivalent). NB: Patients on doses =10 mg/day are permitted but should have a stable dose for at least 6 weeks prior to randomisation. 16. Administration of a live vaccine in the 4 weeks prior to randomisation. 17. History of malignancy or neoplastic disease, except successfully treated basal or squamous cell carcinoma of the skin >5 years ago. 18. Severely impaired renal function (estimated glomerular filtration rate =30 mL/min according to the Cockcroft-Gault formula). 19. Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
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