NCT00777816暂停2 期
A Blinded, Placebo-controlled, Study of the Safety and Pharmacokinetics of XOMA 052 Administered to Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 18
- 主要终点
- Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
研究概览
简要总结
Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to patients with active, stable, moderate to severe rheumatoid arthritis (RA).
It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control in subjects with RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American College of Rheumatology (ACR) diagnostic criteria for RA
- •Moderate to severe disease, defined as follows - At least six tender and six swollen joints (28 joint count) AND ESR > 28 mm/hr or CRP > 1.0 mg/dL
- •Current duration of RA at Screening ≥ 6 months and ≤ 20 years
- •RA and other medical conditions must be stable.
- •Age ≥ 18 and ≤ 75 at Screening
- •Weight ≥ 80 lbs (36.3 kg) and ≤ 275 lbs (125.0 kg)
- •For females with child-bearing potential, a negative serum pregnancy test
排除标准
- •Major surgery within 28 days prior to Day 0
- •Joint replacement surgery within 60 days prior to Day 0 or joint replacement surgery planned within 9 months following Day 0
- •Known HIV antibody, or hepatitis B surface antigen
- •History of malignancy within 5 years prior to Screening other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
- •Immunodeficiency
- •History or symptoms of a demyelinating disease
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 < 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
- •History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma. A subject who has had a positive PPD test but has completed a course of treatment for tuberculosis, had a documented vaccination against tuberculosis, or had a negative QuantiFERON -TB test result is eligible.
- •Chronic obstructive pulmonary disease (COPD), asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily
- •Significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis)
- •Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function. If the diagnosis of liver disease was based on positive Hep C serology due to prior vaccination, the subject is eligible.
- •Pregnant or planning to become pregnant during the course of the study, or breast-feeding
研究组 & 干预措施
1
Active Comparator
干预措施: XOMA 052 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
时间窗: Day 0 pre-dose through Day 56
次要结局
- Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.(Day 0 Pre-dose through Day 56)
- Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.(Day 0 pre-dose through Day 56)
- Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol.(Day 0 pre-dose through Day 56)
研究者
相似试验
已完成
1 期
Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes MellitusType 2 DiabetesNCT00513214XOMA (US) LLC68
已完成
2 期
Efficacy, Safety and Tolerability of CX157 in Treatment Resistant DepressionTreatment Resistant DepressionNCT01246908CeNeRx BioPharma Inc.360
已完成
1 期
A randomised, double-blind, placebo-controlled, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of PMX205 in healthy volunteers.Motor Neuron DiseaseInflammatory and Immune System - Other inflammatory or immune system disordersNeurological - Neurodegenerative diseasesNeurological - Parkinson's diseaseNeurological - Alzheimer's diseaseParkinson's DiseaseACTRN12619001639112Alsonex Pty Ltd46
已完成
1 期
A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy VolunteersHealthyNCT01080820Chimerix36
已完成
2 期
Safety and Efficacy of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin MonotherapyType 2 Diabetes MellitusNCT01066715XOMA (US) LLC421