EUCTR2016-003682-26-PL进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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. Males and females ages 18-75 years.
- •2. Meet the ACR/EULAR criteria for RA (Aletaha, 2010) (Appendix 1).
- •3. Not bed- or wheelchair-bound.
- •4. Active RA, as indicated by EULAR Disease Activity Score (DAS28) >3.2 (Fransen, 2005; DAS28, 2015; Appendix 3).
- •5. Demonstrate at least 6 swollen and at least 6 tender joints.
- •6. If taking an NSAID, dose has been stable for at least 1 month prior to the Screening Visit, and will remain unchanged during protocol participation.
- •7. If taking an oral corticosteroid, dose is =10 mg/day prednisone or equivalent, has been stable for at least 1 month prior to the Screening Visit, and will remain unchanged during protocol participation.
- •8. Willing to take oral folate (minimum dose of 5 mg/week) or folinic acid (up to 10 mg/week) for the duration of the study.
- •9. In the Investigator’s opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol.
- •10. Negative Screening serum pregnancy test for female subjects of childbearing potential.
- •11. Female subjects of childbearing potential must use highly effective contraception throughout
- •the course of the trial and for 3 months after. Highly effective methods include hormonal contraception (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants; each method must be used with a barrier method, preferably male condom), intrauterine device or system, tubal ligation, partner vasectomy, or dual (male plus female) barrier methods (each barrier method must be used with a hormonal method). Female subjects who use a hormonally based method must agree to use it in conjunction with a barrier method. Female partners of male study subjects should consider using one of the above methods of contraception as well. Post-menopausal status is defined as menopause for at least 1 year prior to the Screening Visit and must be confirmed by an elevated serum FSH level.
- •12. Male subjects must refrain from sperm donation during treatment and until at least 90 days
- •after the end of study drug dosing. Male subjects with fertile or pregnant partners must agree
- •to use condoms throughout the course of the trial and for 3 months after.
- •13. All aspects of the protocol explained and written informed consent obtained.
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Prior receipt of MTX.
- •2. Prior receipt of >1 regimen of synthetic small-molecule DMARDs.
- •3. Receipt of any non-MTX synthetic small-molecule DMARDs (including but not limited to sulfasalazine, chloroquine/hydroxychloroquine, azathioprine, and/or leflunomide) for at least 1 month prior to the Screening Visitor concomitantly during the trial.
- •4. Receipt of tofacitinib at any time during the 4-week period prior to the Screening Visit or concomitantly during the trial.
- •5. Receipt of a biologic anti-rheumatic agent (including, but not limited to, etanercept, abatacept, infliximab, golimumab, adalimumab, tocilizumab, certolizumab, and rituximab) at any time prior to or concomitantly during the trial.
- •6. Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the Screening Visit.
- •7. Participation in a previous trial CF101 trial.
- •8. Presence or history of uncontrolled arterial hypertension or symptomatic hypotension.
- •9. QTcF interval on Screening Visit ECG or on average of triplicate Baseline Visit ECGs > 450 milliseconds (msec) for males or >470 msec for females (except when QT prolongation is associated with right or left bundle branch block, in which case enrollment is allowed).
- •10. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, congenital Long QT Syndrome.
- •11. Heart disease which is, in the Investigator’s judgment, clinically unstable.
- •12. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades de Pointes (Appendix 5).
- •13. Clinical laboratory abnormalities at the Screening Visit as follows:
- •a. Hemoglobin level <9.0 gm/dL
- •b. Platelet count <125,000/mm3
- •c. White blood cell (WBC) count <3000/mm3
- •d. Serum creatinine level >1.25 times above the central laboratory’s normal limits
- •e. Liver aminotransferase (ALT and/or AST) levels greater than 2 times the central
- •laboratory’s upper limit of normal
- •14. Known or suspected immunodeficiency or human immunodeficiency virus positivity.
- •15. Active or chronic viral hepatitis (B and/or C).
- •16. Active or known latent tuberculosis requiring therapy.
- •17. Anticipated need for live-organism vaccine.
- •18. Pregnancy, lactation, or inadequate contraception as judged by the Investigator.
- •19. Participation in another investigational drug or vaccine trial concurrently or within 30 days
- •prior to Screening.
- •20. Active drug or alcohol dependence.
- •21. History of malignancy within the past 2 years (excluding excised basal or squamous cell
- •carcinoma of the skin).
- •22. Significant acute or chronic medical or psychiatric illness that, in the judgment of the
- •Investigator, could compromise subject safety, limit the subject’s ability to complete the
- •study, and/or compromise the objectives of the study.
研究者
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