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临床试验/NCT00095498
NCT00095498已完成2 期

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

Amgen0 个研究点目标入组 227 人开始时间: 2004年8月11日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Amgen
入组人数
227
主要终点
Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).

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

  • •Diagnosis of RA.
  • •All subjects will be required to have been taking a stable dose of methotrexate.
  • •Active RA at screening defined as greater than or equal to 6 swollen joints.
  • •The presence of erosive disease

排除标准

  • •Received any biologic agent (e.g., Enbrel®, Remicade®, Humira®, Kineret®) or Arava® within 8 weeks before randomization; past use of these agents is allowed.
  • •Steroid use greater than 15 mg/day.
  • •Scheduled for surgery or joint replacement in the hands, wrists or feet.

研究组 & 干预措施

Denosumab 180 mg

Experimental

Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.

干预措施: denosumab (Drug)

Denosumab 60 mg

Experimental

Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.

干预措施: denosumab (Drug)

Placebo

Placebo Comparator

Participants received placebo subcutaneous injections on Day 1 and at Month 6.

干预措施: placebo (Drug)

结局指标

主要结局

Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6

时间窗: Baseline, Month 6

Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism \[EULAR\]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion).

次要结局

  • Change From Baseline in Total Bilirubin at Month 12(Baseline, month 12)
  • Change From Baseline in Bicarbonate at Month 3(baseline, month 3)
  • Change From Baseline in Bicarbonate at Month 12(Baseline, Month 12)
  • Change From Baseline in Total Bilirubin at Month 6(Baseline, month 6)
  • Change From Baseline in Alanine Amino Transferase at Month 3(Baseline, month 3)
  • Change From Baseline in Blood Urea Nitrogen at Month 1(Baseline, month 1)
  • Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6(Baseline, Month 6)
  • Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6(Baseline, Month 6)
  • Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12(Baseline, Month 12)
  • Percent Change From Baseline in Serum CTX at Month 12(Baseline, Month 12)
  • Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12(Baseline, Month 12)
  • Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody(Baseline to Month 12)
  • Change From Baseline in Albumin at Month 6(Baseline, month 6)
  • Change From Baseline in Albumin at Month 12(Baseline, month 12)
  • Change From Baseline in Blood Urea Nitrogen at Month 12(baseline, month 12)
  • Change From Baseline in Alkaline Phosphatase at Month 3(baseline, month 3)
  • Change From Baseline in Total Bilirubin at Month 1(baseline, month 1)
  • Change From Baseline in Blood Urea Nitrogen at Month 3(Baseline, month 3)
  • Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12(Baseline, Month 12)
  • Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3(Baseline, Month 3)
  • Change From Baseline in Albumin at Month 3(Baseline, month 3)
  • Change From Baseline in Bicarbonate at Month 1(baseline, month 1)
  • Change From Baseline in Radiographic Erosion Score at Month 12(Baseline, Month 12)
  • Change From Baseline in Radiographic Erosion Score at Month 6(Baseline, Month 6)
  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12(Baseline, Month 12)
  • Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1(Baseline, Month 1)
  • Percent Change From Baseline in Serum CTX at Month 6(Baseline, Month 6)
  • Percent Change From Baseline in P1NP at Month 6(Baseline, Month 6)
  • Number of Participants With Anti-Denosumab Binding Antibodies(Assessed at Baseline and at Months 1, 3, 6 and 12.)
  • Change From Baseline in Albumin at Month 1(Baseline, month 1)
  • Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12(Baseline, Month 12)
  • Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6(Baseline, Month 6)
  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1(Baseline, Month 1)
  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6(Baseline, month 6)
  • Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1(Baseline, Month 1)
  • Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12(Baseline, Month 12)
  • Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6(Baseline, Month 6)
  • Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3(Baseline, Month 3)
  • Percent Change From Baseline in P1NP at Month 12(Baseline, Month 12)
  • Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3(Baseline, Month 3)
  • Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6(Baseline, Month 6)
  • Change From Baseline in Alkaline Phosphatase at Month 6(baseline, month 6)
  • Change From Baseline in Alkaline Phosphatase at Month 12(baseine, month 12)
  • Change From Baseline in Total Bilirubin at Month 3(Baseline, month 3)
  • Change From Baseline in Alkaline Phosphatase at Month 1(Baseline, month 1)
  • Change From Baseline in Bicarbonate at Month 6(Baseline, month 6)
  • Change From Baseline in Blood Urea Nitrogen at Month 6(Baseline, month 6)
  • Change From Baseline in Calcium at Month 6(baseline, month 6)
  • Change From Baseline in Calcium (Corrected) at Month 3(baseline, month 3)
  • Change From Baseline in Calcium (Corrected) at Month 12(Baselien, Month 12)
  • Change From Baseline in Chloride at Month 12(Baseline, month 12)
  • Change From Baseline in Gamma-Glutamyl Transferase at Month 12(Baseline, month 12)
  • Change From Baseline in Glucose at Month 3(Baseline, month 3)
  • Change From Baseline in Chloride at Month 1(baseline, month 1)
  • Change From Baseline in Creatinine at Month 6(Baseline, month 6)
  • Change From Baseline in Creatinine at Month 12(Baseline, month 12)
  • Change From Baseline in Glucose at Month 1(Baseline, month 1)
  • Change From Baseline in Potassium at Month 6(Baseline, month 6)
  • Change From Baseline in Magnesium at Month 3(Baseline, month 3)
  • Change From Baseline in Magnesium at Month 6(Baseline, month 6)
  • Change From Baseline in Sodium at Month 6(Baseline, month 6)
  • Change From Baseline in Calcium at Month 1(baseline. month 1)
  • Change From Baseline in Calcium (Corrected) at Month 6(Baseline, Month 6)
  • Change From Baseline in Gamma-Glutamyl Transferase at Month 6(Baseline, month 6)
  • Change From Baseline in Potassium at Month 1(Baseline, month 1)
  • Change From Baseline in Magnesium at Month 12(Baseline, month 12)
  • Change From Baseline in Sodium at Month 1(Baseline, month 1)
  • Change From Baseline in Phosphorus at Month 6(Baseline, month 6)
  • Change From Baseline in Lymphocytes at Month 6(Baseline, month 6)
  • Change From Baseline in Calcium at Month 3(Baseline, month 3)
  • Change From Baseline in Chloride at Month 3(Baseline, month 3)
  • Change From Baseline in Creatinine at Month 3(Baseline, month 3)
  • Change From Baseline in Gamma-Glutamyl Transferase at Month 1(Baseline, month 1)
  • Change From Baseline in Glucose at Month 6(Baseline, month 6)
  • Change From Baseline in Magnesium at Month 1(Baseline, month 1)
  • Change From Baseline in Total Protein at Month 3(Baseline, month 3)
  • Change From Baseline in Total Protein at Month 6(Baseline, month 6)
  • Change From Baseline in Total Protein at Month 12(Baseline, month 12)
  • Change From Baseline in Alanine Amino Transferase at Month 1(Baseline, month 1)
  • Change From Baseline in Alanine Amino Transferase at Month 6(Baseline, month 6)
  • Change From Baseline in Eosinophils at Month 6(Baseline, month 6)
  • Change From Baseline in Calcium at Month 12(Baseline, month 12)
  • Change From Baseline in Calcium (Corrected) at Month 1(Baseline, month 1)
  • Change From Baseline in Chloride at Month 6(Baseline, month 6)
  • Change From Baseline in Creatinine at Month 1(Baseline, month 1)
  • Change From Baseline in Gamma-Glutamyl Transferase at Month 3(Baseline, month 3)
  • Change From Baseline in Glucose at Month 12(baseline, month 12)
  • Change From Baseline in Potassium at Month 12(Baseline, month 12)
  • Change From Baseline in Sodium at Month 3(Baseline, Month 3)
  • Change From Baseline in Phosphorus at Month 12(Baseline, month 12)
  • Change From Baseline in Aspartate Amino Transferase at Month 12(Baseline, month 12)
  • Change From Baseline in White Blood Cells at Month 3(Baseline, month 3)
  • Change From Baseline in Red Blood Cells at Month 6(Baseline, month 6)
  • Change From Baseline in Potassium at Month 3(Baseline, month 3)
  • Change From Baseline in Sodium at Month 12(Baseline, month 12)
  • Change From Baseline in Phosphorus at Month 1(Baseline, month 1)
  • Change From Baseline in Phosphorus at Month 3(Baseline, month 3)
  • Change From Baseline in Aspartate Amino Transferase(Baseline, month 6)
  • Change From Baseline in Basophils at Month 3(Baseline, month 3)
  • Change From Baseline in Basophils at Month 12(Baseline, month 12)
  • Change From Baseline in Eosinophils at Month 12(Baseline, month 12)
  • Change From Baseline in Hematocrit at Month 3(Baseline, month 3)
  • Change From Baseline in Hematocrit at Month 6(Baseline, month 6)
  • Change From Baseline in Lymphocytes at Month 3(Baseline, month 3)
  • Change From Baseline in Monocytes at Month 12(Baseline, month 12)
  • Change From Baseline in Total Neutrophils at Month 1(Baseline, month 1)
  • Change From Baseline in Platelets at Month 6(Baseline, month 6)
  • Change From Baseline in Total Protein at Month 1(Baseline, month 1)
  • Change From Baseline in Aspartate Amino Transferase at Month 1(Baseline, month 1)
  • Change From Baseline in Aspartate Amino Transferase at Month 3(Baseline, month 3)
  • Change From Baseline in Alanine Amino Transferase at Month 12(Baseline, month 12)
  • Change From Baseline in Basophils at Month 1(baseline, month 1)
  • Change From Baseline in Basophils at Month 6(Baseline, month 6)
  • Change From Baseline in Hematocrit at Month 1(Baseline, month 1)
  • Change From Baseline in Hemoglobin at Month 3(Baseline, month 3)
  • Change From Baseline in Lymphocytes at Month 12(Baseline, month 12)
  • Change From Baseline in Monocytes at Month 1(Baseline, month 1)
  • Change From Baseline in Monocytes at Month 6(Baseline, month 6)
  • Change From Baseline in Platelets at Month 3(Baseline, month 3)
  • Change From Baseline in Total Neutrophils at Month 6(Baseline, month 6)
  • Change From Baseline in Red Blood Cells at Month 12(Baseline, month 12)
  • Change From Baseline in White Blood Cells at Month 1(Baseline, month 1)
  • Change From Baseline in Eosinophils at Month 1(Baseline, month 1)
  • Change From Baseline in Eosinophils at Month 3(Baseline, month 3)
  • Change From Baseline in Hematocrit at Month 12(Baseline, month 12)
  • Change From Baseline in Hemoglobin at Month 1(Baseline, month 1)
  • Change From Baseline in Hemoglobin at Month 12(Baseline, month 12)
  • Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3(Month 1, month 3, month 6, month 12)
  • Change From Baseline in Hemoglobin at Month 6(Baseline, month 6)
  • Change From Baseline in Lymphocytes at Month 1(Baseline, month 1)
  • Change From Baseline in Monocytes at Month 3(Baseline, month 3)
  • Change From Baseline in Total Neutrophils at Month 3(Baseline, month 3)
  • Change From Baseline in Total Neutrophils at Month 12(Baseline, month 12)
  • Change From Baseline in Platelets at Month 1(Baseline, month 1)
  • Change From Baseline in White Blood Cells at Month 6(Baseline, month 6)
  • Change From Baseline in White Blood Cells at Month 12(Baseline, month 12)
  • Change From Baseline in Platelets at Month 12(Baseline, month 12)
  • Change From Baseline in Red Blood Cells at Month 1(Baseline, month 1)
  • Change From Baseline in Red Blood Cells at Month 3(Baseline, month 3)

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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