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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095498
• Other study ID #: 20040144
• Status: Completed
• Phase: Phase 2
• Start date: August 11, 2004
• Est. completion date: April 1, 2007

Study information

• Verified date: October 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: April 1, 2007
• Est. primary completion date: April 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• placebo
placebo subcutaneous injection
• denosumab
For subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (4)

Cohen SB, Dore RK, Lane NE, Ory PA, Peterfy CG, Sharp JT, van der Heijde D, Zhou L, Tsuji W, Newmark R; Denosumab Rheumatoid Arthritis Study Group. Denosumab treatment effects on structural damage, bone mineral density, and bone turnover in rheumatoid arthritis: a twelve-month, multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Arthritis Rheum. 2008 May;58(5):1299-309. doi: 10.1002/art.23417. — View Citation

Deodhar A, Dore RK, Mandel D, Schechtman J, Shergy W, Trapp R, Ory PA, Peterfy CG, Fuerst T, Wang H, Zhou L, Tsuji W, Newmark R. Denosumab-mediated increase in hand bone mineral density associated with decreased progression of bone erosion in rheumatoid arthritis patients. Arthritis Care Res (Hoboken). 2010 Apr;62(4):569-74. doi: 10.1002/acr.20004. — View Citation

Dore RK, Cohen SB, Lane NE, Palmer W, Shergy W, Zhou L, Wang H, Tsuji W, Newmark R; Denosumab RA Study Group. Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates. Ann Rheum Dis. 2010 May;69(5):872-5. doi: 10.1136/ard.2009.112920. Epub 2009 Sep 3. — View Citation

Sharp JT, Tsuji W, Ory P, Harper-Barek C, Wang H, Newmark R. Denosumab prevents metacarpal shaft cortical bone loss in patients with erosive rheumatoid arthritis. Arthritis Care Res (Hoboken). 2010 Apr;62(4):537-44. doi: 10.1002/acr.20172. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at 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).	Baseline, Month 6
Secondary	Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at 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).	Baseline, Month 12
Secondary	Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at 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).	Baseline, Month 6
Secondary	Change From Baseline in Radiographic Erosion Score at 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.	Baseline, Month 12
Secondary	Change From Baseline in Radiographic Erosion Score at 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.	Baseline, Month 6
Secondary	Change From Baseline in Radiographic Joint Space Narrowing Score at 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.	Baseline, Month 12
Secondary	Change From Baseline in Radiographic Joint Space Narrowing Score at 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.	Baseline, Month 6
Secondary	Percent Change From Baseline in Lumbar Spine Bone Mineral Density at 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).	Baseline, Month 1
Secondary	Percent Change From Baseline in Lumbar Spine Bone Mineral Density at 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).	Baseline, month 6
Secondary	Percent Change From Baseline in Lumbar Spine Bone Mineral Density at 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).	Baseline, Month 12
Secondary	Percent Change From Baseline in Femoral Neck Bone Mineral Density at 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).	Baseline, Month 1
Secondary	Percent Change From Baseline in Femoral Neck Bone Mineral Density at 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).	Baseline, Month 6
Secondary	Percent Change From Baseline in Femoral Neck Bone Mineral Density at 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).	Baseline, Month 12
Secondary	Percent Change From Baseline in Total Hip Bone Mineral Density at 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).	Baseline, Month 1
Secondary	Percent Change From Baseline in Total Hip Bone Mineral Density at 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).	Baseline, Month 6
Secondary	Percent Change From Baseline in Total Hip Bone Mineral Density at 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).	Baseline, Month 12
Secondary	Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at 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.	Baseline, Month 3
Secondary	Percent Change From Baseline in Serum CTX at 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.	Baseline, Month 6
Secondary	Percent Change From Baseline in Serum CTX at 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.	Baseline, Month 12
Secondary	Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at 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.	Baseline, Month 3
Secondary	Percent Change From Baseline in P1NP at 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.	Baseline, Month 6
Secondary	Percent Change From Baseline in P1NP at 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.	Baseline, Month 12
Secondary	Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at 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.	Baseline, Month 3
Secondary	Percent Change From Baseline in Urine Type II C-Tx /Creatinine at 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.	Baseline, Month 6
Secondary	Percent Change From Baseline in Urine Type II C-Tx /Creatinine at 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.	Baseline, Month 12
Secondary	Number of Participants With Anti-Denosumab Binding Antibodies	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.	Assessed at Baseline and at Months 1, 3, 6 and 12.
Secondary	Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody	Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab.	Baseline to Month 12
Secondary	Change From Baseline in Albumin at Month 1	Laboratory Chemistry Albumin	Baseline, month 1
Secondary	Change From Baseline in Albumin at Month 3	Laboratory chemistry albumin	Baseline, month 3
Secondary	Change From Baseline in Albumin at Month 6	Laboratory chemistry albumin	Baseline, month 6
Secondary	Change From Baseline in Albumin at Month 12	Laboratory chemistry albumin	Baseline, month 12
Secondary	Change From Baseline in Alkaline Phosphatase at Month 1	Laboratory chemistry alkaline phoshatatse	Baseline, month 1
Secondary	Change From Baseline in Alkaline Phosphatase at Month 3	Laboratory chemisrty alkaline phosphatase	baseline, month 3
Secondary	Change From Baseline in Alkaline Phosphatase at Month 6	Laboratory chemistry alkaline phosphatase	baseline, month 6
Secondary	Change From Baseline in Alkaline Phosphatase at Month 12	Laboratory chemistry alkaline phosphatase	baseine, month 12
Secondary	Change From Baseline in Bicarbonate at Month 1	Laboratory chemistry bicarbonate	baseline, month 1
Secondary	Change From Baseline in Bicarbonate at Month 3	Laboratory chemistry bicarbonate	baseline, month 3
Secondary	Change From Baseline in Bicarbonate at Month 6	Laboratory chemistry bicarbonate	Baseline, month 6
Secondary	Change From Baseline in Bicarbonate at Month 12	Laboratory chemistry bicarbonate	Baseline, Month 12
Secondary	Change From Baseline in Total Bilirubin at Month 1	Laboratory chemistry total bilirubin	baseline, month 1
Secondary	Change From Baseline in Total Bilirubin at Month 3	Laboratory chemistry total bilirubin	Baseline, month 3
Secondary	Change From Baseline in Total Bilirubin at Month 6	Laboratory chemistry total bilirubin	Baseline, month 6
Secondary	Change From Baseline in Total Bilirubin at Month 12	Laboratory chemistry total bilirubin	Baseline, month 12
Secondary	Change From Baseline in Blood Urea Nitrogen at Month 1	Laboratory chemistry blood urea nitrogen	Baseline, month 1
Secondary	Change From Baseline in Blood Urea Nitrogen at Month 3	Laboratory chemistry blood urea nitrogen	Baseline, month 3
Secondary	Change From Baseline in Blood Urea Nitrogen at Month 6	Laboratory chemistry blood urea nitrogen	Baseline, month 6
Secondary	Change From Baseline in Blood Urea Nitrogen at Month 12	Laboratory chemistry blood urea nitrogen	baseline, month 12
Secondary	Change From Baseline in Calcium at Month 1	Laboratory chemistry calcium	baseline. month 1
Secondary	Change From Baseline in Calcium at Month 3	Laboratory chemistry calcium	Baseline, month 3
Secondary	Change From Baseline in Calcium at Month 6	Laboratory chemistry calcium	baseline, month 6
Secondary	Change From Baseline in Calcium at Month 12	Laboratory chemistry calcium	Baseline, month 12
Secondary	Change From Baseline in Calcium (Corrected) at Month 1	Laboratory chemistry albumin-adjusted calcium	Baseline, month 1
Secondary	Change From Baseline in Calcium (Corrected) at Month 3	Laboratory chemistry albumin-adjusted calcium	baseline, month 3
Secondary	Change From Baseline in Calcium (Corrected) at Month 6	Laboratory chemistry albumin-adjusted calcium	Baseline, Month 6
Secondary	Change From Baseline in Calcium (Corrected) at Month 12	Laboratory chemistry albumin-adjusted calcium	Baselien, Month 12
Secondary	Change From Baseline in Chloride at Month 1	Laboratory chemistry chloride	baseline, month 1
Secondary	Change From Baseline in Chloride at Month 3	Laboratory chemistry chloride	Baseline, month 3
Secondary	Change From Baseline in Chloride at Month 6	Laboratory chemistry chloride	Baseline, month 6
Secondary	Change From Baseline in Chloride at Month 12	Laboratory chemistry chloride	Baseline, month 12
Secondary	Change From Baseline in Creatinine at Month 1	Laboratory chemistry creatinine	Baseline, month 1
Secondary	Change From Baseline in Creatinine at Month 3	Laboratory chemistry creatinine	Baseline, month 3
Secondary	Change From Baseline in Creatinine at Month 6	Laboratory chemistry creatinine	Baseline, month 6
Secondary	Change From Baseline in Creatinine at Month 12	Laboratory chemistry creatinine	Baseline, month 12
Secondary	Change From Baseline in Gamma-Glutamyl Transferase at Month 1	Laboratory chemistry gamma-glutamyl transferase	Baseline, month 1
Secondary	Change From Baseline in Gamma-Glutamyl Transferase at Month 3	Laboratory chemistry gamma-glutamyl transferase	Baseline, month 3
Secondary	Change From Baseline in Gamma-Glutamyl Transferase at Month 6	Laboratory chemistry gamma-glutamyl transferase	Baseline, month 6
Secondary	Change From Baseline in Gamma-Glutamyl Transferase at Month 12	Laboratory chemistry gamma-glutamyl transferase	Baseline, month 12
Secondary	Change From Baseline in Glucose at Month 1	Laboratory chemistry glucose	Baseline, month 1
Secondary	Change From Baseline in Glucose at Month 3	Laboratory chemistry glucose	Baseline, month 3
Secondary	Change From Baseline in Glucose at Month 6	Laboratory chemistry glucose	Baseline, month 6
Secondary	Change From Baseline in Glucose at Month 12	Laboratory chemistry glucose	baseline, month 12
Secondary	Change From Baseline in Potassium at Month 1	Laboratory chemistry potassium	Baseline, month 1
Secondary	Change From Baseline in Potassium at Month 3	Laboratory chemistry potassium	Baseline, month 3
Secondary	Change From Baseline in Potassium at Month 6	Laboratory chemistry potassium	Baseline, month 6
Secondary	Change From Baseline in Potassium at Month 12	Laboratory chemistry potassium	Baseline, month 12
Secondary	Change From Baseline in Magnesium at Month 1	Laboratory chemistry magnesium	Baseline, month 1
Secondary	Change From Baseline in Magnesium at Month 3	Laboratory chemistry magnesium	Baseline, month 3
Secondary	Change From Baseline in Magnesium at Month 6	Laboratory chemistry magnesium	Baseline, month 6
Secondary	Change From Baseline in Magnesium at Month 12	Laboratory chemistry magnesium	Baseline, month 12
Secondary	Change From Baseline in Sodium at Month 1	Laboratory chemistry sodium	Baseline, month 1
Secondary	Change From Baseline in Sodium at Month 3	Change From Baseline in Sodium at Month 3	Baseline, Month 3
Secondary	Change From Baseline in Sodium at Month 6	Laboratory chemistry sodium	Baseline, month 6
Secondary	Change From Baseline in Sodium at Month 12	Laboratory chemistry sodium	Baseline, month 12
Secondary	Change From Baseline in Phosphorus at Month 1	Laboratory chemistry phosphorus	Baseline, month 1
Secondary	Change From Baseline in Phosphorus at Month 3	Laboratory chemistry phosphorus	Baseline, month 3
Secondary	Change From Baseline in Phosphorus at Month 6	Laboratory chemistry phosphorus	Baseline, month 6
Secondary	Change From Baseline in Phosphorus at Month 12	Change From Baseline in Phosphorus at Month 12	Baseline, month 12
Secondary	Change From Baseline in Total Protein at Month 1	Laboratory chemistry total protein	Baseline, month 1
Secondary	Change From Baseline in Total Protein at Month 3	Laboratory chemistry total protein	Baseline, month 3
Secondary	Change From Baseline in Total Protein at Month 6	Laboratory chemistry total protein	Baseline, month 6
Secondary	Change From Baseline in Total Protein at Month 12	Laboratory chemistry total protein	Baseline, month 12
Secondary	Change From Baseline in Aspartate Amino Transferase at Month 1	Laboratory chemistry aspartate amino transferase	Baseline, month 1
Secondary	Change From Baseline in Aspartate Amino Transferase at Month 3	Laboratory chemistry aspartate amino transferase	Baseline, month 3
Secondary	Change From Baseline in Aspartate Amino Transferase	Laboratory chemistry aspartate amino transferase	Baseline, month 6
Secondary	Change From Baseline in Aspartate Amino Transferase at Month 12	Laboratory chemistry aspartate amino transferase	Baseline, month 12
Secondary	Change From Baseline in Alanine Amino Transferase at Month 1	Laboratory chemistry alanine amino transferase	Baseline, month 1
Secondary	Change From Baseline in Alanine Amino Transferase at Month 3	Laboratory Chemistry alanine amino transferase	Baseline, month 3
Secondary	Change From Baseline in Alanine Amino Transferase at Month 6	Laboratory chemistry alanine amino transferase	Baseline, month 6
Secondary	Change From Baseline in Alanine Amino Transferase at Month 12	Laboratory chemistry alanine amino transferase	Baseline, month 12
Secondary	Change From Baseline in Basophils at Month 1	Laboratory hematology basophils	baseline, month 1
Secondary	Change From Baseline in Basophils at Month 3	Laboratory hematology basophils	Baseline, month 3
Secondary	Change From Baseline in Basophils at Month 6	Laboratory hematology basophils	Baseline, month 6
Secondary	Change From Baseline in Basophils at Month 12	Laboratory hematology basophils	Baseline, month 12
Secondary	Change From Baseline in Eosinophils at Month 1	Laboratory hematology eosinophils	Baseline, month 1
Secondary	Change From Baseline in Eosinophils at Month 3	Laboratory hematology eosinophils	Baseline, month 3
Secondary	Change From Baseline in Eosinophils at Month 6	Laboratory hematology eosinophils	Baseline, month 6
Secondary	Change From Baseline in Eosinophils at Month 12	Laboratory hematology eosinophils	Baseline, month 12
Secondary	Change From Baseline in Hematocrit at Month 1	Laboratory hematology hematocrit	Baseline, month 1
Secondary	Change From Baseline in Hematocrit at Month 3	Laboratory hematology hematocrit	Baseline, month 3
Secondary	Change From Baseline in Hematocrit at Month 6	Laboratory hematology hematocrit	Baseline, month 6
Secondary	Change From Baseline in Hematocrit at Month 12	Laboratory hematology hematocrit	Baseline, month 12
Secondary	Change From Baseline in Hemoglobin at Month 1	Laboratory hematology hemoglobin	Baseline, month 1
Secondary	Change From Baseline in Hemoglobin at Month 3	Laboratory hematology hemoglobin	Baseline, month 3
Secondary	Change From Baseline in Hemoglobin at Month 6	Laboratory hematology hemoglobin	Baseline, month 6
Secondary	Change From Baseline in Hemoglobin at Month 12	Laboratory hematology hemoglobin	Baseline, month 12
Secondary	Change From Baseline in Lymphocytes at Month 1	Laboratory hematology lymphocytes	Baseline, month 1
Secondary	Change From Baseline in Lymphocytes at Month 3	Laboratory hematology lymphocytes	Baseline, month 3
Secondary	Change From Baseline in Lymphocytes at Month 6	Laboratory hematology lymphocytes	Baseline, month 6
Secondary	Change From Baseline in Lymphocytes at Month 12	Laboratory hematology lymphocytes	Baseline, month 12
Secondary	Change From Baseline in Monocytes at Month 1	Laboratory hematology monocytes	Baseline, month 1
Secondary	Change From Baseline in Monocytes at Month 3	Laboratory hematology monocytes	Baseline, month 3
Secondary	Change From Baseline in Monocytes at Month 6	Laboratory hematology monocytes	Baseline, month 6
Secondary	Change From Baseline in Monocytes at Month 12	Laboratory hematology monocytes	Baseline, month 12
Secondary	Change From Baseline in Total Neutrophils at Month 1	Laboratory hematology total neutrophils	Baseline, month 1
Secondary	Change From Baseline in Total Neutrophils at Month 3	Laboratory hematology total neutrophils	Baseline, month 3
Secondary	Change From Baseline in Total Neutrophils at Month 6	Laboratory hematology total neutrophils	Baseline, month 6
Secondary	Change From Baseline in Total Neutrophils at Month 12	Laboratory hematology total neutrophils	Baseline, month 12
Secondary	Change From Baseline in Platelets at Month 1	Laboratory hematology platelets	Baseline, month 1
Secondary	Change From Baseline in Platelets at Month 3	Laboratory hematology platelets	Baseline, month 3
Secondary	Change From Baseline in Platelets at Month 6	Laboratory hematology platelets	Baseline, month 6
Secondary	Change From Baseline in Platelets at Month 12	Laboratory hematology platelets	Baseline, month 12
Secondary	Change From Baseline in Red Blood Cells at Month 1	Laboratory hematology red blood cells	Baseline, month 1
Secondary	Change From Baseline in Red Blood Cells at Month 3	Laboratory hematology red blood cells	Baseline, month 3
Secondary	Change From Baseline in Red Blood Cells at Month 6	Laboratory hematology red blood cells	Baseline, month 6
Secondary	Change From Baseline in Red Blood Cells at Month 12	Laboratory hematology red blood cells	Baseline, month 12
Secondary	Change From Baseline in White Blood Cells at Month 1	Laboratory hematology white blood cells	Baseline, month 1
Secondary	Change From Baseline in White Blood Cells at Month 3	Laboratpry hematology white blood cells	Baseline, month 3
Secondary	Change From Baseline in White Blood Cells at Month 6	Laboratory hematology white blood cells	Baseline, month 6
Secondary	Change From Baseline in White Blood Cells at Month 12	Laboratory hematology white blood cells	Baseline, month 12
Secondary	Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3	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.	Month 1, month 3, month 6, month 12

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