EUCTR2009-012566-32-HU进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate
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
- 240
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 is capable of understanding and giving written, voluntary informed consent before study screening
- •Male or female = 18 and = 70 years of age at time of screening
- •Subject is diagnosed with RA as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria
- •Subject has active RA defined as = 6 swollen joints (out of 66 joints examined) and = 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal [DIPs] joints) and at least 1 of the following at screening:
- •- ESR = 28 mm
- •- CRP > 15 mg/L
- •Subject has at least 1 of the following at screening:
- •- Rheumatoid factor (RF) positive
- •- Anti-cyclic citrullinated peptide (anti-CCP) antibody positive
- •Subject has had RA for at least 6 months
- •Subject has a negative test for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV)
- •Subject has a negative serum pregnancy test within 28 days before initiating IP
- •for female subjects (except those at least 3 years postmenopausal or surgically
- •sterile) and a negative urine pregnancy test at baseline
- •Subject is currently taking methotrexate consecutively for = 12 weeks and on a
- •stable dose of methotrexate at 15 to 25 mg weekly for = 4 weeks at day -1. A
- •lower methotrexate dose is acceptable (but no lower than 10 mg per week) if it is
- •the highest tolerated dose, however, toxicity documentation by the investigator is
- •required. Toxicities that would permit use of a lower dose of methotrexate
- •include hepatic, gastrointestinal, mucosal, and hematologic. All subjects must
- •take folic acid to minimize toxicity (at least 5 mg per week).
- •If the subject is currently taking non-steroidal anti-inflammatory drugs (NSAIDs),
- •the subject must be on stable use (eg, PRN use of a stable dose) = 4 weeks prior
- •to screening.
- •If the subject is currently taking oral corticosteroids (not to exceed the equivalent
- •of 10 mg of prednisone per day), the subject must be on a stable dose = 4 weeks
- •prior to screening.
- •Subject has had a chest radiograph within 3 months prior to the first
- •administration of IP that does not demonstrate abnormalities suggestive of a
- •malignancy or current active infection, including tuberculosis
- •Subject has a negative purified protein derivative (PPD) test within 30 days prior
- •to the first IP dose. Tuberculin skin tests should be considered positive when
- •they have greater than or equal to 5 mm of induration at 48 to 72 hours after test
- •is placed. Subjects with a positive tuberculin skin test (if less than or equal to
- •14 mm of induration) are allowed if they have a history of Bacillus
- •Calmette-Guerin vaccination with a negative Quantiferon test in the past year,
- •no symptoms per tuberculosis worksheet, and a negative chest X-ray.
- •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
- •Rheumatoid arthritis related
- •Subject had prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
- •Subject has Class IV RA according to ACR revised response criteria (see
- •Appendix C)
- •Subject is diagnosed with Felty’s syndrome (RA, splenomegaly and granulocytopenia)
- •Subject has a planned surgical intervention for a pretreatment condition within the duration of the study, including the follow up period
- •Other medical conditions
- •Subject has any active CTC grade 2 or higher infection (including chronic or localized infections) within 30 days prior to screening, at screening, or during screening period prior to first investigational product (IP) dose
- •Subject has a serious infection, defined as requiring hospitalization or IV antibiotics within 8 weeks before screening
- •Subject has recurrent or chronic infections, defined as = 3 infections requiring anti-microbials over the past 12 months prior to screening
- •Subject has one or more significant concurrent medical conditions, including:
- •- Type 1 diabetes
- •- Poorly controlled type 2 diabetes (hemoglobin A1c > 8.0)
- •- Symptomatic heart failure (New York Heart Association class II, III, or IV)
- •- Myocardial infarction within the last year
- •- Current or history of unstable angina pectoris within the last year
- •- Uncontrolled hypertension as defined by a resting blood pressure
- •= 160/95 mmHg prior to randomization (confirmed by a repeat assessment)
- •- Severe chronic pulmonary disease (eg, requiring oxygen therapy)
- •- Major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus), with the exception of secondary Sjögren’s syndrome
- •- Multiple sclerosis or any other demyelinating disease
- •- Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin).
- •- History of alcoholic liver disease
- •- Any condition that, in the opinion of the investigator, might cause this study to
- •be detrimental to the subject
- •Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject’s last study visit including the follow-up
- •Female subject is not willing to abstain from sexual intercourse or use 2 highly
- •effective forms of birth control for the duration of the study including the follow-up
- •period (except women at least 3 years postmenopausal or surgically sterile).
- •Highly effective methods of birth control for women include but are not limited to
- •birth control pills, Depo-Provera® injections, contraceptive implants, or occlusive
- •cap (barrier method) in combination with barrier methods used by the man.
- •Male subject is not willing to abstain from sexual intercourse or use 2 highly
- •effective forms of birth control for the duration of the study including the follow-up
- •period, plus an additional 10 weeks (except for men who are surgically sterile or
- •whose female partners are at least 3 years postmenopausal or surgically sterile).
- •Highly effective methods of birth control include but are not limited to a condom
- •in combination with hormonal birth control or barrier methods used by the
- •Male subject (including vasectomised males) with a pregnant female partner is
- •not willing to use effective methods to ensure that an unborn child is not exposed
- •to AMG 827 via semen. Effective methods to ensure that an unborn child is not
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