EUCTR2015-003289-97-PL进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 276
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
- •Female subjects of childbearing potential: test negative for pregnancy at screening and agree not to breastfeed
- •Female subjects: agree to use a reliable method of birth control from the start of screening until 28 days after the last dose of study drug or be of nonchildbearing potential:
- •oare postmenopausal
- •ohave undergone bilateral tubal ligation, bilateral oophorectomy, and/or hysterectomy
- •ohave another medical cause of female infertility
- •Male subjects: agree to use a reliable method of birth control from the start of screening until 2 weeks after the last dose of study drug or have undergone vasectomy at least 6 weeks prior to screening
- •Have a diagnosis of RA based on the 2010 ACR/European League against Rheumatism criteria
- •Have at least 1 of the following:
- •orheumatoid factor or anti-citrullinated peptide antibodies (ACPA) at screening OR
- •oradiographs documenting bony erosions
- •have active RA, defined as:
- •o Part A: =3 swollen joints (based on 66-joint counts)
- •o=6 swollen joints (based on 66-joint counts)
- •o=6 tender joints (based on 68-joint counts)
- •o hsCRP greater than the upper limit of normal (ULN) OR positive for ACPA
- •Part B only: have had inadequate response, loss of response, or intolerance to at least 1 synthetic or biologic DMARD treatment for RA, regardless of treatment duration
- •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 164
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Have received any of the following synthetic immunosuppressive therapies under the defined conditions:
- •omethotrexate (MTX), hydroxychloroquine, sulfasalazine, or leflunomide at an UNSTABLE PRESCRIBED DOSE (defined as a change in prescription) within 28 days prior to baseline
- •oconcomitant treatment with MTX PLUS leflunomide within 28 days prior to baseline gold salts, kinase inhibitors (such as tofacitinib), cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to screening
- •o Part B only: any prior treatment with a product directly targeting BTK (marketed or investigational)
- •Have received any of the following biologic immunosuppressive therapies:
- •oetanercept, adalimumab, or anakinra within 14 days prior to baseline
- •oinfliximab, certolizumab pegol, golimumab, abatacept, or tocilizumab within 4 weeks prior to baseline
- •obelimumab, natalizumab, or vedolizumab within 6 months prior to baseline
- •oPart A only: B-cell–depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-CD3 antibody) within 12 months prior to screening
- •o Part B only: B-cell–depleting agents (such as rituximab) or other cell-depleting biologics (eg, anti-CD3 antibody) at any time prior to screening
- •Have received any of the following:
- •oparenteral corticosteroids within 28 days prior to baseline (A single intra-articular corticosteroid injection is permitted within 28 days prior to baseline if no more than 40 mg triamcinolone [or equivalent])
- •ooral prednisone (or equivalent) >10 mg/day or UNSTABLE PRESCRIBED DOSE within 28 days prior to baseline
- •oa chronic narcotic drug at an UNSTABLE PRESCRIBED DOSE within 28 days prior to baseline
- •ogemfibrozil or alfentanil, dihydroergotamine, dofetilide, ergotamine, fentanyl, pimozide, or quinidine within 28 days prior to baseline
- •Have known hypogammaglobulinemia or a screening serum immunoglobulin G (IgG level) <565 mg/dL (<5.65 g/L)
- •Have hepatitis C virus (HCV) at screening. Subjects who are anti-HCVAb positive and HCV ribonucleic acid (RNA) negative can be enrolled in the study.
- •Have hepatitis B virus (HBV) at screening, defined as (1) positive for hepatitis B surface antigen OR (2) positive for anti-hepatitis B core antibody (HBcAb) AND positive for HBV DNA. Have human immunodeficiency virus antibody
- •Have active tuberculosis (TB)
- •Are at high risk of infection or have recent evidence of clinically significant infection
- •Have had lymphoma, leukemia, or any malignancy within the previous 5 years except for basal cell or squamous epithelial carcinomas of the skin
- •Have received a live (attenuated) vaccine within 28 days prior to baseline or plan to receive one during the study
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