NCT01712178已完成2 期
Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis
AbbVie (prior sponsor, Abbott)42 个研究点 分布在 8 个国家目标入组 100 人开始时间: 2012年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 42
- 主要终点
- Serum Concentrations of Adalimumab at Weeks 12 and 24
研究概览
简要总结
A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for pharmacodynamics, pharmacokinetics, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject, 18 years or older who has a diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR)-classification criteria or the new American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010-classification criteria and has a disease duration for a minimum of 3 months.
- •Subjects must be naïve to biologic therapy.
- •Subject must meet the following criteria for the joint assessment: • At least 6 swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.
- •Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) Subjects not on methotrexate at baseline must remain without methotrexate throughout the study. Subjects on prior Methotrexate (MTX) must have discontinued at least 28 days prior to Week 0 (Day 1). b) Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapy other than Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10 mg) must discontinue it for at least 28 days before the first dose of investigational product at Week 0 (Day 1).
- •Female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least 1 of the following methods of birth control throughout the study and for at least 150 days after the last dose of study drug: • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD). • Hormonal contraceptives for 90 days prior to study drug administration. • Vasectomized partner(s).
- •Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer subcutaneous (SC) injections.
- •Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile, chest x-ray (CXR), and 12 lead electrocardiogram (ECG) performed during Screening.
- •Subject has a negative Tuberculosis (TB) screening assessment (including a (Purified Protein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test or equivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) at Screening. If a subject has evidence of a latent Tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks of anti-Tuberculosis (TB) therapy or have documented completion of a course of anti-Tuberculosis (TB) therapy prior to Baseline.
- •Subjects must be willing to provide written consent and to comply with the requirements of this study protocol.
排除标准
- •Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks from Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed. Oral of less than or equal to 10 mg/d prednisone equivalent are allowed.
- •Subject has been treated with any investigational drug of a chemical or biological nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Baseline Visit.
- •Subject has a history of acute inflammatory joint disease of different origin other than Rheumatoid Arthritis (RA) (e.g., seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, gouty arthritis, or any arthritis with onset prior to age 17 years).
- •Known hypersensitivity to adalimumab or its excipients.
- •Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
- •History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
- •History of invasive infection (e.g., listeriosis and histoplasmosis), human immunodeficiency syndrome (HIV).
- •Chronic recurring infections or active Tuberculosis (TB).
- •History of moderate to severe congestive heart failure (New York Heart Association (NYHA) class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- •Subject received any live vaccine within 3 months prior to study drug administration. - Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis).
- •Positive pregnancy test at Screening or Baseline.
- •Subject is considered by the investigator, for any reason, to be unsuitable candidate for the study
研究组 & 干预措施
New formulation of adalimumab 40 mg every other week
Experimental
New formulation adalimumab 40 mg every other week
干预措施: Adalimumab, new formulation (Biological)
Current formulation adalimumab 40 mg every other week
Active Comparator
Current formulation adalimumab 40 mg every other week
干预措施: Adalimumab, current formulation (Biological)
结局指标
主要结局
Serum Concentrations of Adalimumab at Weeks 12 and 24
时间窗: Measured at Weeks 12 and 24
Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.
Mean Disease Activity Scores (DAS28) at Weeks 12 and 24
时间窗: Measured at Weeks 12 and 24
The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
次要结局
- Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24(Measured at Weeks 12 and 24)
- Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24(Measured at Weeks 12 and 24)
- Percentage of Participants Positive for Anti-adalimumab Antibody(Measured through Week 24)
- Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24(Measured at Weeks 12 and 24)
- Number of Participants With Adverse Events(From time of informed consent to 70 days following the last dose of study drug)
- Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24(Measured at Weeks 12 and 24)
- Mean Injection Site Pain on a Visual Analogue Scale (VAS)(Immediately after injections on Day 1)
研究者
研究点 (42)
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