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

4SC AG0 个研究点目标入组 244 人2009年7月3日

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注册库

who.int

开始日期

2009年7月3日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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

•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