EUCTR2009-012953-39-CZ进行中（未招募）不适用
A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 4SC AG
- 入组人数
- 244
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 with active RA
- •2. Age > 18 years
- •3. Gender: Males and females
- •4. Patients with active RA of functional classes I, II or III according to the criteria of American Rheumatism Association for RA
- •5. DAS28(ESR) = 4.5 (DAS28 formula with 4 variables using ESR)
- •6. Patients who have received weekly doses of MTX (10–25 mg/week) for a minimum of 3 months prior to Day 1 dosing, and who have received a stable MTX dose of 10–25 mg/week without any change in route or change in folic acid supplementation for at least 6 weeks prior to Day 1 dosing
- •7. Patients may receive up to 10 mg/day of oral prednisolone or steroid equivalent. Dose must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements.
- •8. Patients having sufficient intelligence to understand the nature of the study and are willing and able to communicate with the investigator and comply with all study requirements
- •9. Patients willing to give informed consent in writing at enrolment into the study
- •10. Males willing to utilize safe methods of contraception
- •11. Females of childbearing potential willing to utilize two safe and independent methods of contraception throughout the course of the study
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting any of the following exclusion criteria cannot be admitted to the trial:
- •1. Patients with RA of functional classes IV according to the criteria of American Rheumatism Association for RA
- •2. Patients who have received any of the following treatments must abide by the indicated washout period:
- •- Leflunomide requires a 6 month washout period prior toDay 1 dosing
- •- Oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing
- •- Cyclosporine, abatacept, etanercept, adalimumab, infliximab, and rituximab require a 60 day washout period prior to Day 1 dosing
- •- Cyclophosphamide requires a 180 day washout period prior to Day 1 dosing
- •- Parenteral or intra-articular corticosteroids require a 30 day washout period prior to Day 1 dosing
- •3. Receipt of the following drugs within 4 weeks prior to dosing:
- •- Sulfasalazine
- •- Hydroxychloroquine
- •- Use of corticosteroids > 10 mg/day
- •4. Non-pharmacological treatment (physical therapy)
- •5. Significant cardiac arrhythmia, bradycardia or tachycardia
- •6. Any other significant finding in the ECG
- •7. Congestive heart failure (with exception of NYHA I and II if adequately compensated by medical treatment)
- •8. Uncontrolled arterial hypertension
- •9. Haemoglobin < 8.0 g/dl
- •10. White blood cell count < 3500/mm3
- •11. Platelet count < 125 000/mm3
- •12. Uncontrolled asthma
- •13. History of HIV, Hepatitis B or C
- •14. Liver enzyme levels > twice the laboratory’s upper normal limit
- •15. Serum creatinine level > 1.5 mg/dl
- •16. Glomerular filtration rate < 50 ml / min / 1,73 m² (estimated GRF according to Cockroft-Gault)
- •17. Renal disease or conditions after kidney transplantation
- •18. History of or existence of urolithiasis
- •19. Haematuria (> 10 Ery/field on dipsticks) Exception: Females during menstruation
- •In this case a second examination after the end of menstruation will be performed
- •20. Psychiatric illness
- •21. Active tuberculosis
- •22. Known or suspected immunodeficiency
- •23. History of malignancy within the past 5 years (excl. basal cell carcinoma of the skin)
- •24. Inadequate contraception, pregnancy, lactation
- •25. History of serious drug sensitivity
- •26. History or existing alcohol and drug dependence
- •27. Subject is a heavy smoker (more than 20 cigarettes per day)
- •28. Participation in another investigational drug or vaccine trial within the last 3 months
- •29. Vaccination with life attenuated viruses within 4 weeks prior to study start
- •30. Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the
- •31. Patients possibly dependent on the investigator or the sponsor
研究者
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