EUCTR2012-002324-32-GR进行中（未招募）不适用
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
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
- •Entry Criteria- Inclusion Criteria:
- •are at least 18 years of age
- •have a diagnosis of adult-onset RA as defined by ACR/EULAR 2010 Criteria for the Classification of RA (Aletaha et al. 2010)
- •have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test
- •have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
- •a.If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC for entry or enrollment purposes.
- •have a C-reactive protein (or hsCRP) measurement =1.2 times the upper limit of normal (ULN) based on the most recent data (if available)
- •have had limited or no treatment with MTX
- •a.Patients may have received up to 3 weeks of MTX therapy (administered as a single dose each week) and still be eligible for inclusion in this study.
- •are able to read, understand, and give written informed consent
- •Enrollment Criteria-Inclusion Criteria:
- •have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints assessed at Visit 1 and Visit 2 at the time of randomization
- •have an hsCRP measurement =1.2 times the ULN based on Visit 1 laboratory results by central laboratory testing
- •are rheumatoid factor or anti-CCP antibody positive on screening laboratory test
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Entry Criteria-Exclusion Criteria:
- •have received conventional DMARDs other than MTX
- •are currently receiving corticosteroids at doses >10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
- •have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
- •have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
- •have ever received any biologic DMARD
- •have received interferon therapy within 4 weeks prior to study
- •have received any parenteral corticosteroid administered by IM or IV injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
- •have had 3 or more joints injected with intraarticular corticosteroids within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
- •have active fibromyalgia that would make it difficult to appropriately assess RA activity
- •have a diagnosis of any systemic inflammatory condition other than RA
- •have a diagnosis of Felty’s syndrome
- •have had any major surgery within 8 weeks of study entry
- •have experienced within 12 weeks of study entry: myocardial infarction,unstable ischemic heart disease,stroke,NYHA SIV heart failure
- •have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness
- •are largely/wholly incapacitated permitting little or no self care
- •have an eGFR<40 mL/min/1.73 m2
- •have a history of chronic liver disease
- •have lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy,splenomegaly,active primary,recurrent malignant disease,or have been in remission from clinically significant malignancy for <5 years
- •have been exposed to a live vaccine within 12 weeks prior to randomization or expected to need/receive a live vaccine during the study
- •have a current or recent serious viral,bacterial,fungal,parasitic infection
- •have had symptomatic herpes zoster infection within 12 weeks prior to study entry
- •have a history of disseminated/complicated herpes zoster
- •are immunocompromised
- •have a history of active HBV,HCV,HIV
- •have had household contact with a person with active TB and did not receive prophylaxis
- •have evidence of active TB and did not receive treatment
- •are pregnant,nursing
- •are females of childbearing potential who do not agree to use 2 forms of highly effective birth control
- •are males who do not agree to use 2 forms of highly effective birth control
- •have donated >500 mL of blood within 30 days prior to study entry
- •have a history of chronic alcohol abuse,IV drug abuse,other illicit drug abuse within the 2 years prior to study entry
- •have previously been randomized in this study or any other study investigating baricitinib
- •are unable or unwilling to make themselves available for the duration of the study
- •have received prior treatment with an oral JAK inhibitor
- •are investigator site personnel affiliated with this study and/or their families
- •are Lilly or Incyte employees or either’s designee
- •are currently enrolled in or have discontinued within 30 days of study entry from a clinical trial involving an IP or nonapproved use of a drug or device
- •Enrollment Criteria-Exclusion Crite
研究者
相似试验
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitisMedDRA version: 20.0Level: PTClassification code 10072579Term: Granulomatosis with polyangiitisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 20.0Level: PTClassification code 10063344Term: Microscopic polyangiitisSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 20.1Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disordersEUCTR2016-001121-14-SEChemoCentryx, Inc.300
进行中（未招募）
不适用
A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisModerately to severely active rheumatoid arthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2012-002324-32-SEEli Lilly and Company550
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).EUCTR2016-001121-14-HUChemoCentryx, Inc.300
进行中（未招募）
不适用
A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisEUCTR2012-002324-32-DEEli Lilly and Company550
进行中（未招募）
1 期
A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).EUCTR2016-001121-14-IEChemoCentryx, Inc.300