EUCTR2017-001944-36-BG进行中（未招募）1 期
A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 153
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
- •- Subject has provided informed consent prior to initiation of any study specific
- •activities/procedures.
- •- Age = 18 to = 70 years of age at screening
- •- A diagnosis of RA consistent with the 1987 or 2010 American College of
- •Rheumatology (ACR)/European League Against Rheumatism classification
- •- Active RA defined as:
- •Phase 1b: DAS-28-CRP > 2.6 at screening. The 28-joint count consists of
- •the finger joints excluding the distal interphalangeal joints, the wrists, elbows,
- •shoulders, and knees.
- •Phase 2a: = 6 swollen joints (based on 66-joint count) and = 6 tender joints
- •(based on 68-joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility. Additionally, C-reactive protein (CRP) must be greater than the upper limit of normal (ULN) per the central laboratory at screening.
- •- Receiving treatment with methotrexate for = 12 weeks and on a stable dose
- •= 15 mg weekly for = 8 weeks prior to day 1. A lower methotrexate dose is
- •acceptable (but no lower than 10 mg weekly) if it is the highest tolerated dose
- •and gastrointestinal or hematologic toxicity at doses = 15 mg weekly is
- •documented by the investigator.
- •- Receiving treatment with folic or folinic acid per investigator judgment or
- •according to local standard of care.
- •- Phase 1b only: Subject may be receiving a stable dose of leflunomide,
- •sulfasalazine, hydroxychloroquine, minocycline in combination with methotrexate and the dose must be stable for = 8 weeks prior to day 1.
- •- Subject may be receiving a stable dose of prednisone = 10mg daily or other
- •equivalent corticosteroid dose and the dose must be stable for = 2 weeks prior to
- •- Phase 1b only. Normal or clinically acceptable ECG values (12-lead reporting
- •ventricular rate and PR, QRS, QT and QTc interval) at screening and baseline
- •based on opinion of the investigator.
- •- Immunizations (tetanus, diphtheria, pertussis, seasonal influenza [during flu
- •season], and pneumococcal [polysaccharide] vaccinations) up to date per local
- •standards as determined by the investigator.
- •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 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
排除标准
- •Disease Related:
- •- Class IV RA according to ACR revised response criteria
- •- Diagnosis of Felty’s Syndrome (RA, splenomegaly and granulocytopenia)
- •Other Medical Conditions
- •- Prosthetic joint infection within 3 years of screening or native joint infection within 1 year prior to screening.
- •- Active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to day 1 OR presence of serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to day 1.
- •- Known history of active tuberculosis
- •- Positive test for tuberculosis during screening
- •- Positive for hepatitis B surface antigen, hepatitis B core antibody .
- •- Phase 1b only: Positive for Human Immunodeficiency Virus (HIV) at screening or
- •known to be HIV positive. Phase 2a only: Known history of HIV
- •- Positive drug or alcohol urine test at screening.
- •- Presence of one or more significant concurrent medical conditions per
- •investigator judgment, including but not limited to the following:
- •poorly controlled diabetes or hypertension
- •chronic kidney disease stage IIIb, IV, or V
- •symptomatic heart failure (New York Heart Association class II, III, or IV)
- •myocardial infarction or unstable angina pectoris within the past
- •12 months prior to randomization
- •severe chronic pulmonary disease (eg, requiring oxygen therapy)
- •multiple sclerosis or any other demyelinating disease
- •major chronic inflammatory disease or connective tissue disease other
- •- Malignancy except non-melanoma skin cancers, cervical or breast ductal
- •carcinoma in situ within the last 5 years.
- •- History of alcohol or substance abuse within 6 months of screening
- •- Phase 1b only: Current smoker, and/or use of any nicotine or tobacco containing products within the last 6 months prior to day 1.
- •- Phase 1b only: Subject unwilling to limit alcohol consumption
- •Subjects who have received intra-articular or systemic corticosteroid injections
- •for treatment of acute RA flare (not being part of a regular therapeutic regimen)
- •within 4 weeks prior to screening.
- •- Currently receiving or had treatment with cyclophosphamide, chlorambucil,
- •nitrogen mustard, or any other alkylating agent = 6 months prior to day 1.
- •- Prior treatment with more than a total of 3 therapies that include biologic
- •DMARDs or oral synthetic DMARDs (such as tofacinitib, baricitinib). Prior
- •treatment consists of at least 4 doses of a given therapy where the doses
- •were given solely for treatment of RA disease. Prior therapies must not
- •have been used within the following time periods:
- •? = 4 weeks prior to day 1 for etanercept and anakinra
- •? = 6 months for rituximab
- •? = 2 weeks for oral janus kinase inhibitors
- •? = 9 weeks prior to day 1 for all therapies not listed above
- •- Currently receiving or had treatment with any of the following = 12 weeks prior to day 1:
- •azathioprine
- •cyclosporine
- •mycophenolate mofetil
- •Prosorba column
- •Tacrolimus
- •- Phase 2a only: Currently receiving or had treatment with leflunomide = 12 weeks prior to day 1 unless an active washout with cholestyramine has been performed.
- •- Phase 2a only: Currently receiving or had treatment with any of the following
- •= 4 weeks prior to day 1:
- 另有 6 项未显示
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