Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis
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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 : October 25, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: placebo Drug: denosumab | Phase 2 |
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 |
Actual Study Start Date : | August 11, 2004 |
Actual Primary Completion Date : | April 1, 2007 |
Actual Study Completion Date : | April 1, 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Denosumab 180 mg
Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
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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.
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Drug: placebo
placebo subcutaneous injection |
- 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).
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Change From Baseline in Albumin at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory Chemistry Albumin
- Change From Baseline in Albumin at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry albumin
- Change From Baseline in Albumin at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry albumin
- Change From Baseline in Albumin at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry albumin
- Change From Baseline in Alkaline Phosphatase at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry alkaline phoshatatse
- Change From Baseline in Alkaline Phosphatase at Month 3 [ Time Frame: baseline, month 3 ]Laboratory chemisrty alkaline phosphatase
- Change From Baseline in Alkaline Phosphatase at Month 6 [ Time Frame: baseline, month 6 ]Laboratory chemistry alkaline phosphatase
- Change From Baseline in Alkaline Phosphatase at Month 12 [ Time Frame: baseine, month 12 ]Laboratory chemistry alkaline phosphatase
- Change From Baseline in Bicarbonate at Month 1 [ Time Frame: baseline, month 1 ]Laboratory chemistry bicarbonate
- Change From Baseline in Bicarbonate at Month 3 [ Time Frame: baseline, month 3 ]Laboratory chemistry bicarbonate
- Change From Baseline in Bicarbonate at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry bicarbonate
- Change From Baseline in Bicarbonate at Month 12 [ Time Frame: Baseline, Month 12 ]Laboratory chemistry bicarbonate
- Change From Baseline in Total Bilirubin at Month 1 [ Time Frame: baseline, month 1 ]Laboratory chemistry total bilirubin
- Change From Baseline in Total Bilirubin at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry total bilirubin
- Change From Baseline in Total Bilirubin at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry total bilirubin
- Change From Baseline in Total Bilirubin at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry total bilirubin
- Change From Baseline in Blood Urea Nitrogen at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry blood urea nitrogen
- Change From Baseline in Blood Urea Nitrogen at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry blood urea nitrogen
- Change From Baseline in Blood Urea Nitrogen at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry blood urea nitrogen
- Change From Baseline in Blood Urea Nitrogen at Month 12 [ Time Frame: baseline, month 12 ]Laboratory chemistry blood urea nitrogen
- Change From Baseline in Calcium at Month 1 [ Time Frame: baseline. month 1 ]Laboratory chemistry calcium
- Change From Baseline in Calcium at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry calcium
- Change From Baseline in Calcium at Month 6 [ Time Frame: baseline, month 6 ]Laboratory chemistry calcium
- Change From Baseline in Calcium at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry calcium
- Change From Baseline in Calcium (Corrected) at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Calcium (Corrected) at Month 3 [ Time Frame: baseline, month 3 ]Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Calcium (Corrected) at Month 6 [ Time Frame: Baseline, Month 6 ]Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Calcium (Corrected) at Month 12 [ Time Frame: Baselien, Month 12 ]Laboratory chemistry albumin-adjusted calcium
- Change From Baseline in Chloride at Month 1 [ Time Frame: baseline, month 1 ]Laboratory chemistry chloride
- Change From Baseline in Chloride at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry chloride
- Change From Baseline in Chloride at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry chloride
- Change From Baseline in Chloride at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry chloride
- Change From Baseline in Creatinine at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry creatinine
- Change From Baseline in Creatinine at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry creatinine
- Change From Baseline in Creatinine at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry creatinine
- Change From Baseline in Creatinine at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry creatinine
- Change From Baseline in Gamma-Glutamyl Transferase at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Gamma-Glutamyl Transferase at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Gamma-Glutamyl Transferase at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Gamma-Glutamyl Transferase at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry gamma-glutamyl transferase
- Change From Baseline in Glucose at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry glucose
- Change From Baseline in Glucose at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry glucose
- Change From Baseline in Glucose at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry glucose
- Change From Baseline in Glucose at Month 12 [ Time Frame: baseline, month 12 ]Laboratory chemistry glucose
- Change From Baseline in Potassium at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry potassium
- Change From Baseline in Potassium at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry potassium
- Change From Baseline in Potassium at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry potassium
- Change From Baseline in Potassium at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry potassium
- Change From Baseline in Magnesium at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry magnesium
- Change From Baseline in Magnesium at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry magnesium
- Change From Baseline in Magnesium at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry magnesium
- Change From Baseline in Magnesium at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry magnesium
- Change From Baseline in Sodium at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry sodium
- Change From Baseline in Sodium at Month 3 [ Time Frame: Baseline, Month 3 ]Change From Baseline in Sodium at Month 3
- Change From Baseline in Sodium at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry sodium
- Change From Baseline in Sodium at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry sodium
- Change From Baseline in Phosphorus at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry phosphorus
- Change From Baseline in Phosphorus at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry phosphorus
- Change From Baseline in Phosphorus at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry phosphorus
- Change From Baseline in Phosphorus at Month 12 [ Time Frame: Baseline, month 12 ]Change From Baseline in Phosphorus at Month 12
- Change From Baseline in Total Protein at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry total protein
- Change From Baseline in Total Protein at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry total protein
- Change From Baseline in Total Protein at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry total protein
- Change From Baseline in Total Protein at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry total protein
- Change From Baseline in Aspartate Amino Transferase at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry aspartate amino transferase
- Change From Baseline in Aspartate Amino Transferase at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory chemistry aspartate amino transferase
- Change From Baseline in Aspartate Amino Transferase [ Time Frame: Baseline, month 6 ]Laboratory chemistry aspartate amino transferase
- Change From Baseline in Aspartate Amino Transferase at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry aspartate amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory chemistry alanine amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory Chemistry alanine amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory chemistry alanine amino transferase
- Change From Baseline in Alanine Amino Transferase at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory chemistry alanine amino transferase
- Change From Baseline in Basophils at Month 1 [ Time Frame: baseline, month 1 ]Laboratory hematology basophils
- Change From Baseline in Basophils at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology basophils
- Change From Baseline in Basophils at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology basophils
- Change From Baseline in Basophils at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology basophils
- Change From Baseline in Eosinophils at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology eosinophils
- Change From Baseline in Eosinophils at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology eosinophils
- Change From Baseline in Eosinophils at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology eosinophils
- Change From Baseline in Eosinophils at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology eosinophils
- Change From Baseline in Hematocrit at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology hematocrit
- Change From Baseline in Hematocrit at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology hematocrit
- Change From Baseline in Hematocrit at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology hematocrit
- Change From Baseline in Hematocrit at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology hematocrit
- Change From Baseline in Hemoglobin at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology hemoglobin
- Change From Baseline in Hemoglobin at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology hemoglobin
- Change From Baseline in Hemoglobin at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology hemoglobin
- Change From Baseline in Hemoglobin at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology hemoglobin
- Change From Baseline in Lymphocytes at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology lymphocytes
- Change From Baseline in Lymphocytes at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology lymphocytes
- Change From Baseline in Lymphocytes at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology lymphocytes
- Change From Baseline in Lymphocytes at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology lymphocytes
- Change From Baseline in Monocytes at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology monocytes
- Change From Baseline in Monocytes at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology monocytes
- Change From Baseline in Monocytes at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology monocytes
- Change From Baseline in Monocytes at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology monocytes
- Change From Baseline in Total Neutrophils at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology total neutrophils
- Change From Baseline in Total Neutrophils at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology total neutrophils
- Change From Baseline in Total Neutrophils at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology total neutrophils
- Change From Baseline in Total Neutrophils at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology total neutrophils
- Change From Baseline in Platelets at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology platelets
- Change From Baseline in Platelets at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology platelets
- Change From Baseline in Platelets at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology platelets
- Change From Baseline in Platelets at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology platelets
- Change From Baseline in Red Blood Cells at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology red blood cells
- Change From Baseline in Red Blood Cells at Month 3 [ Time Frame: Baseline, month 3 ]Laboratory hematology red blood cells
- Change From Baseline in Red Blood Cells at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology red blood cells
- Change From Baseline in Red Blood Cells at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology red blood cells
- Change From Baseline in White Blood Cells at Month 1 [ Time Frame: Baseline, month 1 ]Laboratory hematology white blood cells
- Change From Baseline in White Blood Cells at Month 3 [ Time Frame: Baseline, month 3 ]Laboratpry hematology white blood cells
- Change From Baseline in White Blood Cells at Month 6 [ Time Frame: Baseline, month 6 ]Laboratory hematology white blood cells
- Change From Baseline in White Blood Cells at Month 12 [ Time Frame: Baseline, month 12 ]Laboratory hematology white blood cells
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Study Director: | MD | Amgen |
Publications:
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: | October 25, 2021 |
Last Verified: | October 2021 |
arthritis joint pain Methotrexate |
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 |