ISRCTN49455679已完成2 期
A randomised, double blind, placebo-controlled, phase 2a study of the efficacy, safety and pharmacokinetics of MLN3897 in patients with rheumatoid arthritis taking methotrexate
Academic Medical Center (AMC) (The Netherlands)0 个研究点目标入组 191 人开始时间: 2007年1月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 191
研究概览
简要总结
2009 results in https://pubmed.ncbi.nlm.nih.gov/19950299/ (added 15/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18 to 70
- •2. Meeting American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis (RA)
- •3. RA Global Functional Class I,II or III
- •4. Taking MethoTreXate (MTX) for a minimum of six months before screening, dose stable three months
- •5. No more than 10 mg/day prednisone/equivalent
- •6. Stable use of (if on) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), for at least two weeks
- •7. Willing/able to comply to the protocol
- •8. Female of childbearing potential must not be pregnant, or breastfeeding
- •9. Females of childbearing potential and all males must use two accepted forms of contraception for the duration of the study
- •10. Have at least six tender and six swollen joints plus two of the following:
- •a. morning stiffness more than 45 minutes
- •b. Erythrocyte Sedimentation Rate (ESR) more than 28 mm/hr
- •c. C-Reactive Protein (CRP) more than 1.5 mg/dl
排除标准
- •1. Use of any other Disease Modifying Anti-Rheumatic Drugs (DMARDs) than MTX concomitantly or within one month prior to enrolment (in case of leflunomide, three months prior to enrolment or washout with cholestyramine)
- •2. Currently being treated with Tumour Necrotising Factor (TNF)-antagonists or other biologicals (washout period eight weeks)
- •3. Tuberculosis (TB) infection
- •4. Have received investigational drug one month prior to day one
- •5. Have received intra-articular or systemic injection with corticosteroids within one month prior to screening
- •6 to 26. Summary: have any other condition or increased risk of a condition or concomitant use of medication incompatible with the study (including infections, liver and kidney diseases, cardiac conditions/arrythmia, etc.) or have a history of cancer, except for distant history of cured carcinoma in situ of the cervix or Basal Cell Carcinoma (BCC).
研究者
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