EUCTR2011-000436-28-PL进行中（未招募）不适用
A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Each patient must meet all of the following inclusion criteria to be
- •enrolled in the study:
- •1.Prior to screening have voluntarily signed the informed consent form.
- •2.At Screening be at least 18 years of age.
- •3.At screening meet the ACR / EULAR criteria for classification of
- •RA which include:
- •o Joint involvement
- •o Acute-phase reactants
- •o Duration of symptoms
- •4. At screening have moderate to severe RA, defined as involving a
- •minimum (=6 total swollen and =6 total tender) of the 28 joints
- •5. At screening have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score =4.5.Retesting of the CRP and recalculation of DAS28-CRP (due to CRP <0.6 mg/dL) is allowed one time.
- •6. Have been on DMARD therapy for at least 90 days, have been on stable DMARD dose without dosage adjustment or modification for 6 weeks, and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy). Stable DMARD therapy may include a combination of DMARD agents (methotrexate and azsulfadine or methotrexate and hydroxychloroquine as examples).
- •7. At screening female patients of childbearing potential (18 to 55 years of age, inclusive) must have negative urinary BhCG tests at enrollment and study completion.
- •8. Female patients of childbearing potential (18 to 55 years of age,
- •inclusive) must use acceptable methods of birth control (including, but not limited to, IUD, oral or injectable contraceptives, or barrier methods) while in the study.
- •9. If currently taking the following medications she/he has been on a stable dose of the same drug for at least 3 months prior to entering into the trial and will continue on the same dose for the duration of the trial:
- •statins, diuretics, thyroid hormone, hypoglycemic medications, and
- •cardiovascular medications.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Female patient is pregnant,actating,or of child bearing potential not using acceptable methods of birth control including,but not limited to,IUD,oral or injectable contraceptives,barrier methods or abstinence
- •2.Patients who do not respond to therapies that include a dose < 10mg prednisone and either a DMARD combination,DMARDbiologic
- •combination or biologics alone
- •3.Active cardiovascular disease,unless well controlled by appropriate treatment for a minimum of 3months prior to screening
- •4. taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325mg
- •5.Taking oral steroids at a daily prednisone dose,or the equivalent,of >10mg/day within the past 2weeks
- •6.Intraarticular,intramuscular,or intravenous glucocorticoids must not have been given at least 6weeks prior to entering the study or be anticipated to be given at any time during the study
- •7.The need to continue the use of one or multiple NSAIDs at the same time,or the use of acetaminophen on a chronic basis.
- •Ataminophen/paracetamol will be permitted episodically for pain during the trial,not exceeding 1.5gper day for any 3days in any 7day interval.There are no exclusions during the 30day followup period
- •8.All opiate use is prohibited.Such agents include oxycodone,
- •hydrocodone,codeine,morphine sulfate,Demero (meperidine/pethidine),Dilaudid(hydromorphone),combi nation products including Percocet(oxycodone and acetaminophen),Hydrocet(dihydrocodeine
- •andacetaminophen),Tylenol(acetaminophen or paracetamol) with
- •codeine,Vicodin(hydrocodone and acetaminophen),Lorcet(hydrocodone and acetaminophen),Lortabs(hydrocodone and acetaminophen)and extended-release formulations
- •9.Use of any other medications or herbs or non pharmacological
- •treatments eg acupuncutre used for the treatment of pain is prohibited
- •10.Excluded medications include Drugs known to interact with
- •dipyridamole(egadenosine, cholinsteraseb inhibitors,theophylline,caffeine and other xanthine derivatives)or with prednisolone(eganticoagulants,antifungals and HIV protease
- •inhibitors)Systemic anticoagulants,including dipyridamole,Coumadin(warfarin),clopidogrel,ticlopidine and aspirin exceeding 325mg/day(whether or not taken for cardiovascular prophylaxis) All Systemic antifungal agents, including but not limited to the polyene macrolides(amphotericin B),the azole (ketoconazole,miconazole,itraconazole and fluconazole) and the
- •allylamines(terbinafine) All antiHIV drugs belonging to the following
- •classes:members of the nucleoside/nucleotide reverse transcriptase inhibitors,nonnucleoside/ nucleotide reverse transcriptase inhibitors,protease inhibitors,fusion and entry inhibitors and integrin inhibitors.These agents include but are not limited to abacavir,zidovudine,didanosine,tenofovir and efavirenz.
- •11.Has,or has had,any active severe infections,such as
- •osteomyelitis,sepsis,active infectious hepatitis,endocarditis, systemic fungal infection or recent invasive surgical procedures within 30days of study initiation
- •12.Tuberculosis At screening patients with a history of or currently
- •active tuberculosis as per specific country guidelines are excluded
- •Patients with a positive Chest XRay eg apical thickening compatible with TB exposure/latency are excluded Patients who have a positive PPD test, in association with compatible signs and symptoms and/or a positive or indeterminate QFT are
- •excluded Note:A patient with a previous positive PPD test is at risk for development
研究者
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