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: 2021年1月25日

适应症

试验速览

•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

•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).

发起方

Academic Medical Center (AMC) (The Netherlands)