CTRI/2012/12/003205已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Daily CF101 Administered Orally as Monotherapy for 12 Weeks to Patients with Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine Receptors
CanFiteBioPharma Ltd0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Males and females ages 40-65 years
- •2.Meet the criteria of the American College of Rheumatology for RA (Arnett FC et al. Arthritis Rheum 1988;31:315-324, Appendix 1)
- •3.Not bed- or wheelchair-bound
- •4.Active RA, as indicated by the presence of (a)6 swollen joints (28 joint count); AND (b) 6 tender joints (28 joint count); AND either: (c) Westergren ESR of 28 mm/hour; OR (d) CRP level above the upper limit of normal for the central reference laboratory
- •5.Elevated PBMC A3AR expression level, defined as 1.5-fold over a predetermined normal population standard within 2 weeks of beginning dosing
- •6.If taking a nonsteroidal anti-inflammatory agent (NSAID), dose has been stable for at least 1 month prior to the A3AR Qualification 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 A3AR Qualification Visit, and will remain unchanged during protocol participation
- •8.In the Investigatorâ??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
- •9.Negative screening serum pregnancy test for female patients of childbearing potential
- •10.Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method)
- •11.All aspects of the protocol explained and written informed consent obtained
排除标准
- •1.Receipt of any of the following for at least a 1 month washout period prior to the A3AR Qualification Visit: methotrexate, sulfasalazine, oral or injectable gold, azathioprine, minocycline, penicillamine, anakinra
- •2.Receipt of etanercept for at least a 6 week washout period prior to the A3AR Qualification Visit
- •3.Receipt of chloroquine, hydroxychloroquine, cyclosporine, infliximab, golimumab or adalimumab for at least a 2 month washout period prior to the A3AR Qualification Visit
- •4.Receipt of leflunomide for at least a 2 month washout period prior to the A3AR Qualification Visit, unless patient has undergone cholestyramine washout at least 1 month prior to testing
- •5.Receipt of cyclophosphamide for at least a 6 month period prior to the A3AR Qualification Visit
- •6.Receipt of rituximab at any previous time
- •7.Previous failure to respond to methotrexate or any anti-rheumatic biological agent (Not applicable for subjects from India)
- •8.Participation in a previous trial CF101 trial
- •9.Use of oral corticosteroids 10 mg of prednisone, or equivalent, per day
- •10.Change in NSAID dose level for 1 month prior to the A3AR Qualification Visit
- •11.Change in oral corticosteroid dose level during the 1 month prior to the A3AR Qualification Visit
- •12.Receipt of parenteral or intra-articular corticosteroids during the 1 month prior to the A3AR Qualification Visit
- •13.Presence or history of uncontrolled arterial hypertension or symptomatic hypotension
- •14.Significant cardiac arrhythmia or conduction block, congestive heart failure, or any other evidence of clinically significant heart disease; other clinically significant findings on screening electrocardiogram (ECG)
- •15.Hemoglobin level 9.0 gm/dL at the screening visit
- •16.Platelet count 125,000/mm3 at the screening visit
- •17.White blood cell count 3000/mm3 at the screening visit
- •18.Serum creatinine level outside the central laboratoryâ??s normal limits at the screening visit
- •19.Liver aminotransferase (ALT and/or AST) levels greater than 2 times the central laboratoryâ??s upper limit of normal at the screening visit
- •20.Known or suspected immunodeficiency, including a Screening serum globulin value of 2.0 g/dL, or human immunodeficiency virus positivity
- •21.Pregnancy, lactation, or inadequate contraception as judged by the Investigator
- •22.Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to screening
- •23.History of active drug or alcohol dependence
- •24.History of malignancy within the past 5 years (excluding excised basal or squamous cell carcinoma of the skin)
- •25.Diagnosis of Parkinsonâ??s Disease
- •26.Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patientâ??s ability to complete the study, and/or compromise the objectives of the study
- •Additional India-specific Exclusion Criteria:
- •27.Prior receipt of any DMARD, including but not limited to those mentioned in the Exclusion Criteria 1-6 above
研究者
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