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Study Complete
Sponsor ID
20040144

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

Sponsor ID
20040144
Clinicaltrials.gov ID
NCT00095498
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
227
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change From Baseline in RA-MRI Erosion Score at Month 6

Timeframe: Baseline, month 6

Secondary Outcome Measures

Change from Baseline in Radiographic Total Modified Sharp Score at Month 12

Timeframe: Baseline, month 12

Change from Baseline in Radiographic Total Modified Sharp Score at Month 6

Timeframe: Baseline, month 6

Change from Baseline in Radiographic Erosion Score at Month 12

Timeframe: Baseline, month 12

Change from Baseline in Radiographic Erosion Score at Month 6

Timeframe: Baseline, month 6

Change from Baseline in Radiographic Joint Space Narrowing Score at Month 12

Timeframe: Baseline, month 12

Change from Baseline in Radiographic Joint Space Narrowing Score at Month 6

Timeframe: Baseline, month 6

Percent Change from Baseline in Lumbar Spine Bone Mineral Density at Month 1

Timeframe: Baseline, month 1

Percent Change from Baseline in Lumbar Spine Bone Mineral Density at Month 6

Timeframe: Baseline, month 6

Percent Change from Baseline in Lumbar Spine Bone Mineral Density at Month 12

Timeframe: Baseline, month 12

Percent Change from Baseline in Femoral Neck Bone Mineral Density at Month 1

Timeframe: Baseline, month 1

Percent Change from Baseline in Femoral Neck Bone Mineral Density at Month 6

Timeframe: Baseline , month 6

Percent Change from Baseline in Femoral Neck Bone Mineral Density at Month 12

Timeframe: Baseline, month 12

Percent Change from Baseline in Total Hip Bone Mineral Density at Month 1

Timeframe: Baseline, month 1

Percent Change from Baseline in Total Hip Bone Mineral Density at Month 6

Timeframe: Baseline, month 6

Percent Change from Baseline in Total Hip Bone Mineral Density at Month 12

Timeframe: Baseline, month 12

Percent Change From Baseline in Serum CTX at Month 3

Timeframe: Baseline, month 3

Percent Change From Baseline in Serum CTX at Month 6

Timeframe: Baseline, month 6

Percent Change From Baseline in Serum CTX at Month 12

Timeframe: Baseline, month 12

Percent Change From Baseline in P1NP at Month 3

Timeframe: Baseline, month 3

Percent Change From Baseline in P1NP at Month 6

Timeframe: Baseline, month 6

Percent Change From Baseline in P1NP at Month 12

Timeframe: Baseline, month 12

Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 3

Timeframe: Baseline, month 3

Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6

Timeframe: Baseline, month 6

Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12

Timeframe: Baseline, month 12

Subject Incidence of Anti-Denosumab Binding Antibody

Timeframe: Baseline to month 12

Subject Incidence of Anti-Denosumab Binding Antibody and Neutralizing Antibody

Timeframe: Baseline to month 12

Change From Baseline in Albumin at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Albumin at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Albumin at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Albumin at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Alkaline Phosphatase at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Alkaline Phosphatase at month 3

Timeframe: baseline, month 3

Change From Baseline in Alkaline Phosphatase at Month 6

Timeframe: baseline, month 6

Change From Baseline in Alkaline Phosphatase at Month 12

Timeframe: baseine, month 12

Change From Baseline in Bicarbonate at Month 1

Timeframe: baseline, month 1

Change From Baseline in Bicarbonate at Month 3

Timeframe: baseline, month 3

Change From Baseline in Bicarbonate at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Bicarbonate at Month 12

Timeframe: Baseline, Month 12

Change From Baseline in Total Bilirubin at Month 1

Timeframe: baseline, month 1

Change From Baseline in Total Bilirubin at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Total Bilirubin at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Total Bilirubin at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Blood Urea Nitrogen at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Blood Urea Nitrogen at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Blood Urea Nitrogen at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Blood Urea Nitrogen at Month 12

Timeframe: baseline, month 12

Change From Baseline in Calcium at Month 1

Timeframe: baseline. month 1

Change From Baseline in Calcium at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Calcium at Month 6

Timeframe: baseline, month 6

Change From Baseline in Calcium at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Calcium (Corrected) at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Calcium (Corrected) at Month 3

Timeframe: baseline, month 3

Change From Baseline in Calcium (Corrected) at Month 6

Timeframe: Baseline, Month 6

Change From Baseline in Calcium (Corrected) at Month 12

Timeframe: Baselien, Month 12

Change From Baseline in Chloride at Month 1

Timeframe: baseline, month 1

Change From Baseline in Chloride at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Chloride at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Chloride at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Creatinine at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Creatinine at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Creatinine at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Creatinine at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Gamma-Glutamyl Transferase at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Gamma-Glutamyl Transferase at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Gamma-Glutamyl Transferase at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Gamma-Glutamyl Transferase at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Glucose at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Glucose at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Glucose at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Glucose at Month 12

Timeframe: baseline, month 12

Change From Baseline in Potassium at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Potassium at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Potassium at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Potassium at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Magnesium at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Magnesium at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Magnesium at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Magnesium at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Sodium at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Sodium at Month 3

Timeframe: Baseline, Month 3

Change From Baseline in Sodium at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Sodium at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Phosphorus at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Phosphorus at month 3

Timeframe: baseline, month 3

Change From Baseline in Phosphorus at Month 6

Timeframe: baseline, month 6

Change From Baseline in Phosphorus at Month 12

Timeframe: baseline, month 12

Change From Baseline in Total Protein at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Total Protein at Month 3

Timeframe: baseline, month 3

Change From Baseline in Total Protein at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Total Protein at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Aspartate Amino Transferase at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Aspartate Amino Transferase at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Aspartate Amino Transferase

Timeframe: Baseline, month 6

Change From Baseline in Aspartate Amino Transferase at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Alanine Amino Transferase at Month 1

Timeframe: baseline, month 1

Change From Baseline in Alanine Amino Transferase at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Alanine Amino Transferase at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Alanine Amino Transferase at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Basophils at Month 1

Timeframe: baseline, month 1

Change From Baseline in Basophils at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Basophils at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Basophils at Month 12

Timeframe: baseline, month 12

Change From Baseline in Eosinophils at Month 1

Timeframe: baseline, month 1

Change From Baseline in Eosinophils at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Eosinophils at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Eosinophils at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Hematocrit at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Hematocrit at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Hematocrit at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Hematocrit at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Hemoglobin at Month 1

Timeframe: baseline, month 1

Change From Baseline in Hemoglobin at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Hemoglobin at Month 6

Timeframe: baseline, month 6

Change From Baseline in Hemoglobin at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Lymphocytes at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Lymphocytes at Month 3

Timeframe: Baseline, month 3

Change From Baseline in Lymphocytes at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Lymphocytes at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Monocytes at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Monocytes at Month 3

Timeframe: baseline, month 3

Change From Baseline in Monocytes at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Monocytes at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Total Neutrophils at Month 1

Timeframe: baseline, month 1

Change From Baseline in Total Neutrophils at Month 3

Timeframe: baseline, month 3

Change From Baseline in Total Neutrophils at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Total Neutrophils at Month 12

Timeframe: Baseline, month 12

Change From Baseline in Platelets at Month 1

Timeframe: Baseline, month 1

Change From Baseline in Platelets at Month 3

Timeframe: baseline, month 3

Change From Baseline in Platelets at Month 6

Timeframe: baseline, month 6

Change From Baseline in Platelets at month 12

Timeframe: Baseline, month 12

Change From Baseline in Red Blood Cells at Month 1

Timeframe: baseline, month 1

Change From Baseline in Red Blood Cells at Month 3

Timeframe: baseline, month 3

Change From Baseline in Red Blood Cells at Month 6

Timeframe: Baseline, month 6

Change From Baseline in Red Blood Cells at Month 12

Timeframe: Baseline, month 12

Change From Baseline in White Blood Cells at Month 1

Timeframe: Baseline, month 1

Change From Baseline in White Blood Cells at Month 3

Timeframe: Baseline, month 3

Change From Baseline in White Blood Cells at Month 6

Timeframe: Baseline, month 6

Change From Baseline in White Blood Cells at Month 12

Timeframe: Baseline, month 12

Subject Incidence of Laboratory CTCAE grade greater or equal to 3

Timeframe: Month 1, month 3, month 6, month 12

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Rheumatoid Arthritis
    • Sex
    All
    Trial Dates
    Aug 2004 - Apr 2007
    Inclusion and Exclusion 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.