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Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00095498
Recruitment Status : Completed
First Posted : November 8, 2004
Results First Posted : January 13, 2014
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: placebo Drug: denosumab Phase 2

Study Design
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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Denosumab 180 mg
Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
 Drug: denosumab
For subcutaneous injection
Other Name: AMG 162
Experimental: Denosumab 60 mg
Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
 Drug: denosumab
For subcutaneous injection
Other Name: AMG 162
Placebo Comparator: Placebo
Participants received placebo subcutaneous injections on Day 1 and at Month 6.
 Drug: placebo
placebo subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6 [ Time Frame: 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).


Secondary Outcome Measures :
  1. Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12 [ Time Frame: Baseline, Month 12 ]
    TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).

  2. Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6 [ Time Frame: Baseline, Month 6 ]
    TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).

  3. Change From Baseline in Radiographic Erosion Score at Month 12 [ Time Frame: Baseline, Month 12 ]
    The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.

  4. Change From Baseline in Radiographic Erosion Score at Month 6 [ Time Frame: Baseline, Month 6 ]
    The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.

  5. Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12 [ Time Frame: Baseline, Month 12 ]
    Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.

  6. Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6 [ Time Frame: Baseline, Month 6 ]
    Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.

  7. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1 [ Time Frame: Baseline, Month 1 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((month 1 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  8. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6 [ Time Frame: Baseline, month 6 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to month 6 calculated using ((month 6 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  9. Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 [ Time Frame: Baseline, Month 12 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  10. Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1 [ Time Frame: Baseline, Month 1 ]

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100.

    Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).


  11. Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6 [ Time Frame: Baseline, Month 6 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  12. Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12 [ Time Frame: Baseline, Month 12 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  13. Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1 [ Time Frame: Baseline, Month 1 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  14. Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6 [ Time Frame: Baseline, Month 6 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  15. Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12 [ Time Frame: Baseline, Month 12 ]
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).

  16. Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3 [ Time Frame: Baseline, Month 3 ]
    Percent change from baseline to Month 3 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.

  17. Percent Change From Baseline in Serum CTX at Month 6 [ Time Frame: Baseline, Month 6 ]
    Percent change from baseline to Month 6 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.

  18. Percent Change From Baseline in Serum CTX at Month 12 [ Time Frame: Baseline, Month 12 ]
    Percent change from Baseline to Month 12 in serum C-Telopeptide (CTX) Type I calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

  19. Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3 [ Time Frame: Baseline, Month 3 ]
    Percent change from baseline to Month 3 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.

  20. Percent Change From Baseline in P1NP at Month 6 [ Time Frame: Baseline, Month 6 ]
    Percent change from baseline to Month 6 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.

  21. Percent Change From Baseline in P1NP at Month 12 [ Time Frame: Baseline, Month 12 ]
    Percent change from baseline to Month 12 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

  22. Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3 [ Time Frame: Baseline, Month 3 ]
    Percent change from baseline to Month 3 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.

  23. Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6 [ Time Frame: Baseline, Month 6 ]
    Percent change from baseline to Month 6 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.

  24. Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12 [ Time Frame: Baseline, Month 12 ]
    Percent change from baseline to Month 12 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

  25. Number of Participants With Anti-Denosumab Binding Antibodies [ Time Frame: Assessed at Baseline and at Months 1, 3, 6 and 12. ]
    Serum from participants was tested for antibodies to denosumab by immuoassay at months 1, 3, 6 and 12. The number of participants with anti-denosumab antibodies at any assessment is reported.

  26. Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody [ Time Frame: Baseline to Month 12 ]
    Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab.

  27. Change From Baseline in Albumin at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory Chemistry Albumin

  28. Change From Baseline in Albumin at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry albumin

  29. Change From Baseline in Albumin at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry albumin

  30. Change From Baseline in Albumin at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry albumin

  31. Change From Baseline in Alkaline Phosphatase at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry alkaline phoshatatse

  32. Change From Baseline in Alkaline Phosphatase at Month 3 [ Time Frame: baseline, month 3 ]
    Laboratory chemisrty alkaline phosphatase

  33. Change From Baseline in Alkaline Phosphatase at Month 6 [ Time Frame: baseline, month 6 ]
    Laboratory chemistry alkaline phosphatase

  34. Change From Baseline in Alkaline Phosphatase at Month 12 [ Time Frame: baseine, month 12 ]
    Laboratory chemistry alkaline phosphatase

  35. Change From Baseline in Bicarbonate at Month 1 [ Time Frame: baseline, month 1 ]
    Laboratory chemistry bicarbonate

  36. Change From Baseline in Bicarbonate at Month 3 [ Time Frame: baseline, month 3 ]
    Laboratory chemistry bicarbonate

  37. Change From Baseline in Bicarbonate at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry bicarbonate

  38. Change From Baseline in Bicarbonate at Month 12 [ Time Frame: Baseline, Month 12 ]
    Laboratory chemistry bicarbonate

  39. Change From Baseline in Total Bilirubin at Month 1 [ Time Frame: baseline, month 1 ]
    Laboratory chemistry total bilirubin

  40. Change From Baseline in Total Bilirubin at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry total bilirubin

  41. Change From Baseline in Total Bilirubin at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry total bilirubin

  42. Change From Baseline in Total Bilirubin at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry total bilirubin

  43. Change From Baseline in Blood Urea Nitrogen at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry blood urea nitrogen

  44. Change From Baseline in Blood Urea Nitrogen at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry blood urea nitrogen

  45. Change From Baseline in Blood Urea Nitrogen at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry blood urea nitrogen

  46. Change From Baseline in Blood Urea Nitrogen at Month 12 [ Time Frame: baseline, month 12 ]
    Laboratory chemistry blood urea nitrogen

  47. Change From Baseline in Calcium at Month 1 [ Time Frame: baseline. month 1 ]
    Laboratory chemistry calcium

  48. Change From Baseline in Calcium at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry calcium

  49. Change From Baseline in Calcium at Month 6 [ Time Frame: baseline, month 6 ]
    Laboratory chemistry calcium

  50. Change From Baseline in Calcium at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry calcium

  51. Change From Baseline in Calcium (Corrected) at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry albumin-adjusted calcium

  52. Change From Baseline in Calcium (Corrected) at Month 3 [ Time Frame: baseline, month 3 ]
    Laboratory chemistry albumin-adjusted calcium

  53. Change From Baseline in Calcium (Corrected) at Month 6 [ Time Frame: Baseline, Month 6 ]
    Laboratory chemistry albumin-adjusted calcium

  54. Change From Baseline in Calcium (Corrected) at Month 12 [ Time Frame: Baselien, Month 12 ]
    Laboratory chemistry albumin-adjusted calcium

  55. Change From Baseline in Chloride at Month 1 [ Time Frame: baseline, month 1 ]
    Laboratory chemistry chloride

  56. Change From Baseline in Chloride at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry chloride

  57. Change From Baseline in Chloride at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry chloride

  58. Change From Baseline in Chloride at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry chloride

  59. Change From Baseline in Creatinine at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry creatinine

  60. Change From Baseline in Creatinine at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry creatinine

  61. Change From Baseline in Creatinine at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry creatinine

  62. Change From Baseline in Creatinine at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry creatinine

  63. Change From Baseline in Gamma-Glutamyl Transferase at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry gamma-glutamyl transferase

  64. Change From Baseline in Gamma-Glutamyl Transferase at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry gamma-glutamyl transferase

  65. Change From Baseline in Gamma-Glutamyl Transferase at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry gamma-glutamyl transferase

  66. Change From Baseline in Gamma-Glutamyl Transferase at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry gamma-glutamyl transferase

  67. Change From Baseline in Glucose at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry glucose

  68. Change From Baseline in Glucose at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry glucose

  69. Change From Baseline in Glucose at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry glucose

  70. Change From Baseline in Glucose at Month 12 [ Time Frame: baseline, month 12 ]
    Laboratory chemistry glucose

  71. Change From Baseline in Potassium at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry potassium

  72. Change From Baseline in Potassium at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry potassium

  73. Change From Baseline in Potassium at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry potassium

  74. Change From Baseline in Potassium at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry potassium

  75. Change From Baseline in Magnesium at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry magnesium

  76. Change From Baseline in Magnesium at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry magnesium

  77. Change From Baseline in Magnesium at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry magnesium

  78. Change From Baseline in Magnesium at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry magnesium

  79. Change From Baseline in Sodium at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry sodium

  80. Change From Baseline in Sodium at Month 3 [ Time Frame: Baseline, Month 3 ]
    Change From Baseline in Sodium at Month 3

  81. Change From Baseline in Sodium at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry sodium

  82. Change From Baseline in Sodium at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry sodium

  83. Change From Baseline in Phosphorus at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry phosphorus

  84. Change From Baseline in Phosphorus at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry phosphorus

  85. Change From Baseline in Phosphorus at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry phosphorus

  86. Change From Baseline in Phosphorus at Month 12 [ Time Frame: Baseline, month 12 ]
    Change From Baseline in Phosphorus at Month 12

  87. Change From Baseline in Total Protein at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry total protein

  88. Change From Baseline in Total Protein at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry total protein

  89. Change From Baseline in Total Protein at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry total protein

  90. Change From Baseline in Total Protein at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry total protein

  91. Change From Baseline in Aspartate Amino Transferase at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry aspartate amino transferase

  92. Change From Baseline in Aspartate Amino Transferase at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory chemistry aspartate amino transferase

  93. Change From Baseline in Aspartate Amino Transferase [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry aspartate amino transferase

  94. Change From Baseline in Aspartate Amino Transferase at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry aspartate amino transferase

  95. Change From Baseline in Alanine Amino Transferase at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory chemistry alanine amino transferase

  96. Change From Baseline in Alanine Amino Transferase at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory Chemistry alanine amino transferase

  97. Change From Baseline in Alanine Amino Transferase at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory chemistry alanine amino transferase

  98. Change From Baseline in Alanine Amino Transferase at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory chemistry alanine amino transferase

  99. Change From Baseline in Basophils at Month 1 [ Time Frame: baseline, month 1 ]
    Laboratory hematology basophils

  100. Change From Baseline in Basophils at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology basophils

  101. Change From Baseline in Basophils at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology basophils

  102. Change From Baseline in Basophils at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology basophils

  103. Change From Baseline in Eosinophils at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology eosinophils

  104. Change From Baseline in Eosinophils at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology eosinophils

  105. Change From Baseline in Eosinophils at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology eosinophils

  106. Change From Baseline in Eosinophils at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology eosinophils

  107. Change From Baseline in Hematocrit at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology hematocrit

  108. Change From Baseline in Hematocrit at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology hematocrit

  109. Change From Baseline in Hematocrit at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology hematocrit

  110. Change From Baseline in Hematocrit at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology hematocrit

  111. Change From Baseline in Hemoglobin at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology hemoglobin

  112. Change From Baseline in Hemoglobin at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology hemoglobin

  113. Change From Baseline in Hemoglobin at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology hemoglobin

  114. Change From Baseline in Hemoglobin at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology hemoglobin

  115. Change From Baseline in Lymphocytes at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology lymphocytes

  116. Change From Baseline in Lymphocytes at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology lymphocytes

  117. Change From Baseline in Lymphocytes at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology lymphocytes

  118. Change From Baseline in Lymphocytes at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology lymphocytes

  119. Change From Baseline in Monocytes at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology monocytes

  120. Change From Baseline in Monocytes at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology monocytes

  121. Change From Baseline in Monocytes at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology monocytes

  122. Change From Baseline in Monocytes at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology monocytes

  123. Change From Baseline in Total Neutrophils at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology total neutrophils

  124. Change From Baseline in Total Neutrophils at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology total neutrophils

  125. Change From Baseline in Total Neutrophils at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology total neutrophils

  126. Change From Baseline in Total Neutrophils at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology total neutrophils

  127. Change From Baseline in Platelets at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology platelets

  128. Change From Baseline in Platelets at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology platelets

  129. Change From Baseline in Platelets at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology platelets

  130. Change From Baseline in Platelets at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology platelets

  131. Change From Baseline in Red Blood Cells at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology red blood cells

  132. Change From Baseline in Red Blood Cells at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratory hematology red blood cells

  133. Change From Baseline in Red Blood Cells at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology red blood cells

  134. Change From Baseline in Red Blood Cells at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology red blood cells

  135. Change From Baseline in White Blood Cells at Month 1 [ Time Frame: Baseline, month 1 ]
    Laboratory hematology white blood cells

  136. Change From Baseline in White Blood Cells at Month 3 [ Time Frame: Baseline, month 3 ]
    Laboratpry hematology white blood cells

  137. Change From Baseline in White Blood Cells at Month 6 [ Time Frame: Baseline, month 6 ]
    Laboratory hematology white blood cells

  138. Change From Baseline in White Blood Cells at Month 12 [ Time Frame: Baseline, month 12 ]
    Laboratory hematology white blood cells

  139. Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3 [ Time Frame: Month 1, month 3, month 6, month 12 ]

    Participants with laboratory toxicity of grade 3 or 4, graded according to the Common Terminology Criteria for Adverse Events, version 3.0, on the following general guideline:

    Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death related to AE.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095498


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00095498    
Other Study ID Numbers: 20040144
First Posted: November 8, 2004    Key Record Dates
Results First Posted: January 13, 2014
Last Update Posted: March 15, 2017
Last Verified: February 2017
Keywords provided by Amgen:
arthritis
joint pain
Methotrexate
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs