Rheumatoid Arthritis
Conditions
Keywords
Amgen, RA, AMG 827, 20090061
Brief summary
This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989). All subjects in this study will receive a 210mg injection of AMG827 for treatment for their Rheumatoid Arthritis for up to 5 years.
Interventions
DRUGAMG 827
AMG 827 210 mg
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed consent. * Subject was randomized into study 20090061 and completed the week 16 evaluation. * Negative test for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and/or human immunodeficiency virus (HIV) in subjects if clinically indicated (eg, known recent exposure) in the opinion of the investigator. * Subject must test negative for Tuberculosis.
Exclusion criteria
* Subject had any SAE reported during 20090061 that was considered to be related to IP. * Subject is currently experiencing an infection of CTCAE grade 2 (if requiring oral antibiotics) or higher. Subject is ineligible until the infection is resolved in the opinion of the investigator. * For subjects with \> 4 weeks between the week 16 visit of 20090061 and the planned first IP dose in 20090402, subject has laboratory abnormalities at screening, including: * Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); \>1.5x upper limit of normal) * Serum total bilirubin ≥1.5 mg/dL * Hemoglobin \< 11 g/dL * Platelet count \< 125,000 /mm3 * White blood cell count \< 3,000 cells/mm3 * Absolute neutrophil count \< 2000/mm3 * Estimated creatinine clearance \< 50 mL/min (Cockroft-Gault formula, central lab will calculate value and provide to sites) * Subject has a significant concurrent medical conditions, including: * Type 1 diabetes * Poorly controlled type 2 diabetes (Hemoglobin A1c \> 8.5) * Symptomatic heart failure (New York Heart Association class II, III, or IV) * Myocardial infarction within the last year * Current or history of unstable angina pectoris within the last year * Uncontrolled hypertension as defined by resting blood pressure \> 150/90 mmHg prior to first IP dose (confirmed by a repeat assessment) * Severe chronic pulmonary disease (eg, requiring oxygen therapy) * Major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus), with the exception of secondary Sjögren's syndrome * Multiple sclerosis or any other demyelinating disease * Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin) * Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject * Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject's last study visit including the follow-up period. * Female subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study and at least 40 days after the last dose (except women at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control for women include but are not limited to birth control pills, Depo Provera® injections, contraceptive implants, or occlusive cap (barrier method) in combination with barrier methods used by the man. * Male subject is not willing to abstain from sexual intercourse or use 2 highly effective forms of birth control for the duration of the study, plus an additional 16 weeks after the last dose (except for men who are surgically sterile or whose female partners are at least 3 years postmenopausal or surgically sterile). Highly effective methods of birth control include but are not limited to a condom in combination with hormonal birth control or barrier methods used by the woman. * Male subject (including vasectomised males) with a pregnant female partner is not willing to use effective methods to ensure that an unborn child is not exposed to AMG 827 via semen. Effective methods to ensure that an unborn child is not exposed to AMG 827 via semen include condoms or abstinence. * Subject has used any of the following within 14 days prior to IP initiation * Non-biologic disease-modifying anti-rheumatic drugs (DMARD) other than as allowed in 20090061 * Intra-articular, intramuscular, or intravenous corticosteroids, including adrenocorticotropic hormone * Subject has used any of the following within 3 months prior to IP initiation * Leflunomide * Live vaccines * Commercially available or experimental biologic DMARD except for AMG 827 * Subject has received gold therapy within 6 months prior to IP initiation. * Subject received another investigational agent (other than AMG 827) or participated in an investigational device study subsequent to 20090061. * Other investigational procedures are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Treatment-emergent Adverse Event (TEAE) | Day 1 to Week 52 of study 20090402 | A TEAE was defined as an event that occurred after the first dose date and before the end of study date in study 20090402; or an event that was already present prior to the initiation of the investigational product (i.e. present at study 20090402) baseline but worsened in either frequency or severity after the first dose date and before the end of study date in study 20090402. TEAEs also included serious treatment-emergent adverse events and clinically significant changes from baseline in hematology, chemistry and urinalysis profiles and clinically significant changes in vital sign measurements. |
| Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | An ACR 20 response was defined as at least a 20% improvement from baseline in both tender/painful and swollen joint counts, and a 20% improvement or more in at least 3 of the following 5 criteria: physician global assessment of disease activity (PGA), subject global assessment of disease activity (SGA), participant global assessment of joint pain, participant self-assessment of disability (Health Assessment Questionnaire, HAQ-DI), and acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever had a bigger improvement. Participants were excluded from analysis if an ACR 20 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061. |
| Number of Participants Who Achieved an ACR 50 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | An ACR 50 response was defined as at least a 50% improvement from baseline in both tender/painful and swollen joint counts, and a 50% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 50 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061. |
| Number of Participants Who Achieved an ACR 70 Response | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | An ACR 70 response was defined as at least a 70% improvement from baseline in both tender/painful and swollen joint counts, and a 70% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 70 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061. |
| Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A negative change from baseline indicated a reduction in disease activity. Baseline refers to the baseline in parent study 20090061. |
| Number of Participants With a DAS28 Score < 2.6 | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A score of \<2.6 indicated disease activity remission. 1 participant in the Arm Placebo Q2WK / 210 mg AMG 827 Q2WK was missing baseline data for DAS28. |
| DAS28 Score at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. 1 participant in the Arm Placebo Q2WK / 210 mg AMG 827 Q2WK was missing baseline data for DAS28. |
| CRP Levels at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | All blood samples were taken before the dose of IP was administered. Blood samples were processed and sent to the central laboratory. The central laboratory were responsible for completing assessments. |
| ESR at All Measured Timepoints | Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402. | All blood samples were taken before the dose of IP was administered. ESR was performed locally at each site and the ESR data was submitted to the central laboratory. |
Countries
Bulgaria, Canada, Czechia, Latvia, Mexico, Poland, United Kingdom, United States
Participant flow
Recruitment details
This was an open-label extension of study 20090061 (NCT00950989). Participants were required to complete the Week 16 visit of study 2009061, sign the informed consent form, complete all screening assessments, if applicable, and meet the safety-based eligibility criteria for study 20090402. 211 participants were enrolled across 45 centers in the United States, Canada, Czech Republic, Bulgaria, Latvia, Mexico, Poland, and the United Kingdom from 03 June 2010 to 18 May 2011.
Pre-assignment details
211 participants were enrolled and all 211 participants received study drug.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK).
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate. | 49 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate. | 55 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate. | 53 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter.
Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate. | 54 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative Decision | 43 | 49 | 45 | 46 |
| Overall Study | Adverse Event | 1 | 3 | 0 | 1 |
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Disease Progression | 2 | 1 | 4 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 0 |
| Overall Study | Other | 1 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | Placebo Q2WK / 210 mg AMG 827 Q2WK | 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.9 Years STANDARD_DEVIATION 11.2 | 52.6 Years STANDARD_DEVIATION 10.7 | 54.6 Years STANDARD_DEVIATION 10.7 | 51.6 Years STANDARD_DEVIATION 8.9 | 52.2 Years STANDARD_DEVIATION 10.5 |
| Race Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race Black or African American | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race Hispanic or Latino | 14 Participants | 8 Participants | 12 Participants | 6 Participants | 40 Participants |
| Race White or Caucasian | 34 Participants | 45 Participants | 40 Participants | 47 Participants | 166 Participants |
| Sex: Female, Male Female | 40 Participants | 43 Participants | 40 Participants | 44 Participants | 167 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 13 Participants | 10 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 49 | 18 / 55 | 19 / 53 | 22 / 54 |
| serious Total, serious adverse events | 2 / 49 | 5 / 55 | 1 / 53 | 0 / 54 |
Outcome results
Primary
Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score
The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A negative change from baseline indicated a reduction in disease activity. Baseline refers to the baseline in parent study 20090061.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least 1 dose of AMG 827.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 48 | 0.18 Score on a Scale | — |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 4 | -1.60 Score on a Scale | Standard Deviation 1.3 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 8 | -1.69 Score on a Scale | Standard Deviation 1.32 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 12 | -1.99 Score on a Scale | Standard Deviation 1.08 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 16 | -2.05 Score on a Scale | Standard Deviation 1.27 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 20 | -1.94 Score on a Scale | Standard Deviation 1.35 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 24 | -1.85 Score on a Scale | Standard Deviation 1 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 36 | -1.87 Score on a Scale | Standard Deviation 1.3 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 2 | -1.60 Score on a Scale | Standard Deviation 1.02 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 8 | -1.65 Score on a Scale | Standard Deviation 1.4 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 12 | -1.81 Score on a Scale | Standard Deviation 1.29 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 16 | -1.71 Score on a Scale | Standard Deviation 1.2 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 36 | -1.60 Score on a Scale | Standard Deviation 1.01 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 20 | -1.70 Score on a Scale | Standard Deviation 1.26 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 2 | -1.39 Score on a Scale | Standard Deviation 1.26 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 24 | -1.66 Score on a Scale | Standard Deviation 1.12 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 4 | -1.54 Score on a Scale | Standard Deviation 1.32 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 4 | -1.40 Score on a Scale | Standard Deviation 1.18 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 8 | -1.50 Score on a Scale | Standard Deviation 1.12 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 24 | -1.49 Score on a Scale | Standard Deviation 1.21 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 20 | -1.61 Score on a Scale | Standard Deviation 1.04 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 2 | -1.49 Score on a Scale | Standard Deviation 1.22 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 12 | -1.38 Score on a Scale | Standard Deviation 1.39 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 16 | -1.63 Score on a Scale | Standard Deviation 1.37 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 36 | -1.61 Score on a Scale | Standard Deviation 1.35 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 36 | -1.77 Score on a Scale | Standard Deviation 1.46 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 16 | -1.53 Score on a Scale | Standard Deviation 1.27 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 4 | -1.46 Score on a Scale | Standard Deviation 1.08 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 20 | -1.52 Score on a Scale | Standard Deviation 1.21 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 8 | -1.64 Score on a Scale | Standard Deviation 1.25 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 24 | -1.99 Score on a Scale | Standard Deviation 1.38 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 12 | -1.46 Score on a Scale | Standard Deviation 1.15 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Change From Baseline in Disease Activity Score 28 Joint (DAS28) Score | 20090402 Week 2 | -1.31 Score on a Scale | Standard Deviation 1.07 |
Primary
CRP Levels at All Measured Timepoints
All blood samples were taken before the dose of IP was administered. Blood samples were processed and sent to the central laboratory. The central laboratory were responsible for completing assessments.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 12 | 9.07 Milligrams per Liter (mg/L) | Standard Deviation 9.38 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 4 | 10.70 Milligrams per Liter (mg/L) | Standard Deviation 10.05 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 36 | 8.49 Milligrams per Liter (mg/L) | Standard Deviation 9.96 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 8 | 9.18 Milligrams per Liter (mg/L) | Standard Deviation 10.51 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Baseline | 11.42 Milligrams per Liter (mg/L) | Standard Deviation 12.13 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | Parent Study 20090061 Baseline | 12.95 Milligrams per Liter (mg/L) | Standard Deviation 11.99 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 24 | 7.99 Milligrams per Liter (mg/L) | Standard Deviation 5.82 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 20 | 10.21 Milligrams per Liter (mg/L) | Standard Deviation 12.13 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 2 | 9.67 Milligrams per Liter (mg/L) | Standard Deviation 8.91 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 48 | 22.10 Milligrams per Liter (mg/L) | — |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 16 | 12.09 Milligrams per Liter (mg/L) | Standard Deviation 12.69 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Baseline | 12.23 Milligrams per Liter (mg/L) | Standard Deviation 12.75 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | Parent Study 20090061 Baseline | 14.74 Milligrams per Liter (mg/L) | Standard Deviation 17.5 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 2 | 10.44 Milligrams per Liter (mg/L) | Standard Deviation 10.31 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 4 | 12.79 Milligrams per Liter (mg/L) | Standard Deviation 15.91 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 8 | 12.19 Milligrams per Liter (mg/L) | Standard Deviation 14.18 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 12 | 12.61 Milligrams per Liter (mg/L) | Standard Deviation 14.61 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 16 | 12.91 Milligrams per Liter (mg/L) | Standard Deviation 20.22 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 20 | 10.59 Milligrams per Liter (mg/L) | Standard Deviation 12.05 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 24 | 8.76 Milligrams per Liter (mg/L) | Standard Deviation 9.16 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 36 | 9.92 Milligrams per Liter (mg/L) | Standard Deviation 12.22 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | Parent Study 20090061 Baseline | 18.91 Milligrams per Liter (mg/L) | Standard Deviation 24.35 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Baseline | 14.48 Milligrams per Liter (mg/L) | Standard Deviation 18.84 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 16 | 16.01 Milligrams per Liter (mg/L) | Standard Deviation 17.4 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 24 | 16.50 Milligrams per Liter (mg/L) | Standard Deviation 21.01 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 12 | 15.68 Milligrams per Liter (mg/L) | Standard Deviation 14.82 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 4 | 14.46 Milligrams per Liter (mg/L) | Standard Deviation 15.39 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 2 | 18.58 Milligrams per Liter (mg/L) | Standard Deviation 28.49 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 8 | 13.84 Milligrams per Liter (mg/L) | Standard Deviation 15.62 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 36 | 12.02 Milligrams per Liter (mg/L) | Standard Deviation 17.38 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 20 | 14.14 Milligrams per Liter (mg/L) | Standard Deviation 16.69 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 2 | 10.56 Milligrams per Liter (mg/L) | Standard Deviation 11.04 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 12 | 14.54 Milligrams per Liter (mg/L) | Standard Deviation 13.25 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 16 | 12.92 Milligrams per Liter (mg/L) | Standard Deviation 11.7 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Baseline | 12.25 Milligrams per Liter (mg/L) | Standard Deviation 12.49 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 20 | 14.79 Milligrams per Liter (mg/L) | Standard Deviation 18.38 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 36 | 8.89 Milligrams per Liter (mg/L) | Standard Deviation 8.71 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 4 | 11.47 Milligrams per Liter (mg/L) | Standard Deviation 11.67 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 24 | 9.41 Milligrams per Liter (mg/L) | Standard Deviation 10.04 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | 20090402 Week 8 | 13.20 Milligrams per Liter (mg/L) | Standard Deviation 15.11 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | CRP Levels at All Measured Timepoints | Parent Study 20090061 Baseline | 12.22 Milligrams per Liter (mg/L) | Standard Deviation 10.69 |
Primary
DAS28 Score at All Measured Timepoints
The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. 1 participant in the Arm Placebo Q2WK / 210 mg AMG 827 Q2WK was missing baseline data for DAS28.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 12 | 4.64 Score on a Scale | Standard Deviation 1.17 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 4 | 5.00 Score on a Scale | Standard Deviation 1.41 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 36 | 4.66 Score on a Scale | Standard Deviation 1.13 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 8 | 4.81 Score on a Scale | Standard Deviation 1.34 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Baseline | 5.16 Score on a Scale | Standard Deviation 1.43 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | Parent Study 20090061 Baseline | 6.52 Score on a Scale | Standard Deviation 0.85 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 24 | 4.71 Score on a Scale | Standard Deviation 1.08 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 20 | 4.58 Score on a Scale | Standard Deviation 1.29 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 2 | 4.97 Score on a Scale | Standard Deviation 1.22 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 48 | 7.93 Score on a Scale | — |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 16 | 4.61 Score on a Scale | Standard Deviation 1.23 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Baseline | 5.22 Score on a Scale | Standard Deviation 1.3 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | Parent Study 20090061 Baseline | 6.40 Score on a Scale | Standard Deviation 0.78 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 2 | 5.00 Score on a Scale | Standard Deviation 1.32 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 4 | 4.87 Score on a Scale | Standard Deviation 1.29 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 8 | 4.75 Score on a Scale | Standard Deviation 1.33 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 12 | 4.59 Score on a Scale | Standard Deviation 1.34 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 16 | 4.62 Score on a Scale | Standard Deviation 1.17 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 20 | 4.52 Score on a Scale | Standard Deviation 1.27 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 24 | 4.61 Score on a Scale | Standard Deviation 1.13 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 36 | 4.54 Score on a Scale | Standard Deviation 1.15 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | Parent Study 20090061 Baseline | 6.45 Score on a Scale | Standard Deviation 0.81 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Baseline | 5.33 Score on a Scale | Standard Deviation 1.17 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 16 | 4.93 Score on a Scale | Standard Deviation 1.38 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 24 | 4.94 Score on a Scale | Standard Deviation 1.19 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 12 | 5.13 Score on a Scale | Standard Deviation 1.32 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 4 | 5.06 Score on a Scale | Standard Deviation 1.23 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 2 | 4.96 Score on a Scale | Standard Deviation 1.3 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 8 | 4.97 Score on a Scale | Standard Deviation 1.23 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 36 | 5.06 Score on a Scale | Standard Deviation 1.26 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 20 | 4.73 Score on a Scale | Standard Deviation 1.12 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 2 | 5.09 Score on a Scale | Standard Deviation 1.27 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 12 | 5.02 Score on a Scale | Standard Deviation 1.25 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 16 | 4.94 Score on a Scale | Standard Deviation 1.49 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Baseline | 5.49 Score on a Scale | Standard Deviation 1.38 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 20 | 4.98 Score on a Scale | Standard Deviation 1.33 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 36 | 4.90 Score on a Scale | Standard Deviation 1.56 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 4 | 4.96 Score on a Scale | Standard Deviation 1.3 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 24 | 4.57 Score on a Scale | Standard Deviation 1.61 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | 20090402 Week 8 | 4.79 Score on a Scale | Standard Deviation 1.48 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | DAS28 Score at All Measured Timepoints | Parent Study 20090061 Baseline | 6.41 Score on a Scale | Standard Deviation 0.72 |
Primary
ESR at All Measured Timepoints
All blood samples were taken before the dose of IP was administered. ESR was performed locally at each site and the ESR data was submitted to the central laboratory.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 24 | 42.83 millimeters per hour (mm/hr) | Standard Deviation 25.05 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 8 | 37.40 millimeters per hour (mm/hr) | Standard Deviation 23.26 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 4 | 39.27 millimeters per hour (mm/hr) | Standard Deviation 23.73 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 2 | 36.78 millimeters per hour (mm/hr) | Standard Deviation 21.43 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 20 | 43.41 millimeters per hour (mm/hr) | Standard Deviation 28.27 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 48 | 65.00 millimeters per hour (mm/hr) | — |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | Parent Study 20090061 Baseline | 50.12 millimeters per hour (mm/hr) | Standard Deviation 20.53 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 36 | 36.62 millimeters per hour (mm/hr) | Standard Deviation 16.19 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 16 | 38.21 millimeters per hour (mm/hr) | Standard Deviation 23.08 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 12 | 36.31 millimeters per hour (mm/hr) | Standard Deviation 18.3 |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Baseline | 38.35 millimeters per hour (mm/hr) | Standard Deviation 27.78 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 20 | 35.16 millimeters per hour (mm/hr) | Standard Deviation 24.73 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 36 | 38.69 millimeters per hour (mm/hr) | Standard Deviation 23.22 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | Parent Study 20090061 Baseline | 44.27 millimeters per hour (mm/hr) | Standard Deviation 18.72 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Baseline | 38.15 millimeters per hour (mm/hr) | Standard Deviation 23.79 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 2 | 36.83 millimeters per hour (mm/hr) | Standard Deviation 27.11 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 4 | 36.07 millimeters per hour (mm/hr) | Standard Deviation 21.44 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 8 | 34.65 millimeters per hour (mm/hr) | Standard Deviation 23.14 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 12 | 36.09 millimeters per hour (mm/hr) | Standard Deviation 24.3 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 16 | 40.27 millimeters per hour (mm/hr) | Standard Deviation 26.07 |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 24 | 41.07 millimeters per hour (mm/hr) | Standard Deviation 23.14 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 4 | 40.53 millimeters per hour (mm/hr) | Standard Deviation 23.5 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Baseline | 41.89 millimeters per hour (mm/hr) | Standard Deviation 22.27 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 8 | 38.43 millimeters per hour (mm/hr) | Standard Deviation 19.5 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 36 | 36.85 millimeters per hour (mm/hr) | Standard Deviation 18.07 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 12 | 42.28 millimeters per hour (mm/hr) | Standard Deviation 22.74 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | Parent Study 20090061 Baseline | 45.81 millimeters per hour (mm/hr) | Standard Deviation 21.97 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 24 | 40.58 millimeters per hour (mm/hr) | Standard Deviation 21.12 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 16 | 43.78 millimeters per hour (mm/hr) | Standard Deviation 23.23 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 2 | 37.65 millimeters per hour (mm/hr) | Standard Deviation 19.24 |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 20 | 38.00 millimeters per hour (mm/hr) | Standard Deviation 26.25 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 2 | 37.00 millimeters per hour (mm/hr) | Standard Deviation 25.23 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Baseline | 39.15 millimeters per hour (mm/hr) | Standard Deviation 24.7 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 20 | 40.48 millimeters per hour (mm/hr) | Standard Deviation 26.71 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 16 | 39.43 millimeters per hour (mm/hr) | Standard Deviation 22.81 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 8 | 35.55 millimeters per hour (mm/hr) | Standard Deviation 23.52 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | Parent Study 20090061 Baseline | 45.06 millimeters per hour (mm/hr) | Standard Deviation 20.03 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 36 | 38.07 millimeters per hour (mm/hr) | Standard Deviation 26.39 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 24 | 42.62 millimeters per hour (mm/hr) | Standard Deviation 27.23 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 12 | 39.30 millimeters per hour (mm/hr) | Standard Deviation 22.54 |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | ESR at All Measured Timepoints | 20090402 Week 4 | 38.31 millimeters per hour (mm/hr) | Standard Deviation 24.7 |
Primary
Number of Participants Who Achieved an ACR 50 Response
An ACR 50 response was defined as at least a 50% improvement from baseline in both tender/painful and swollen joint counts, and a 50% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 50 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 48 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 4 | 8 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 8 | 10 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 12 | 13 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 16 | 9 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 20 | 9 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 24 | 6 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 36 | 4 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 2 | 8 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 8 | 9 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 12 | 10 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 16 | 7 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 36 | 2 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 20 | 10 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 2 | 8 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 24 | 6 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 4 | 10 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 4 | 10 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 8 | 13 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 24 | 6 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 20 | 5 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 2 | 12 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 12 | 10 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 16 | 12 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 36 | 2 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 36 | 2 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 16 | 11 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 4 | 10 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 20 | 8 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 8 | 11 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 24 | 9 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 12 | 10 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 50 Response | 20090402 Week 2 | 7 Participants |
Primary
Number of Participants Who Achieved an ACR 70 Response
An ACR 70 response was defined as at least a 70% improvement from baseline in both tender/painful and swollen joint counts, and a 70% improvement or more in at least 3 of the following 5 criteria: PGA, SGA, participant global assessment of joint pain, participant self-assessment of disability (HAQ-DI), and acute phase reactant: ESR or CRP, whichever had a bigger improvement. Participants were excluded from analysis if an ACR 70 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 48 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 4 | 2 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 8 | 5 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 12 | 5 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 16 | 3 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 20 | 4 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 24 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 36 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 2 | 0 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 8 | 4 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 12 | 5 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 16 | 3 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 36 | 0 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 20 | 3 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 2 | 4 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 24 | 2 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 4 | 4 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 4 | 3 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 8 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 24 | 2 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 20 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 2 | 3 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 12 | 2 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 16 | 5 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 36 | 1 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 36 | 2 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 16 | 5 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 4 | 2 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 20 | 1 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 8 | 4 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 24 | 6 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 12 | 2 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an ACR 70 Response | 20090402 Week 2 | 2 Participants |
Primary
Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response
An ACR 20 response was defined as at least a 20% improvement from baseline in both tender/painful and swollen joint counts, and a 20% improvement or more in at least 3 of the following 5 criteria: physician global assessment of disease activity (PGA), subject global assessment of disease activity (SGA), participant global assessment of joint pain, participant self-assessment of disability (Health Assessment Questionnaire, HAQ-DI), and acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever had a bigger improvement. Participants were excluded from analysis if an ACR 20 response could not be determined due to missing component data. Baseline refers to the baseline in parent study 20090061.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 48 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 4 | 27 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 8 | 27 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 12 | 25 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 16 | 19 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 20 | 19 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 24 | 12 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 36 | 7 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 2 | 21 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 8 | 31 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 12 | 24 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 16 | 28 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 36 | 6 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 20 | 24 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 2 | 24 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 24 | 17 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 4 | 26 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 4 | 24 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 8 | 27 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 24 | 17 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 20 | 15 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 2 | 26 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 12 | 23 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 16 | 23 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 36 | 5 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 36 | 7 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 16 | 22 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 4 | 32 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 20 | 15 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 8 | 29 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 24 | 12 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 12 | 22 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response | 20090402 Week 2 | 24 Participants |
Primary
Number of Participants With a DAS28 Score < 2.6
The DAS28 is a composite score that is based on a 28-joint count (using 28 tender and 28 swollen joints), ESR, and SGA. The following formula was used where T/P28 and SW28 represent the tender and swollen 28 joint counts, respectively. The 28 joint counts include 10 proximal interphalangeal, 10 metacarpophalangeal, 2 wrist, 2 elbow, 2 shoulder, and 2 knee joints. DAS28 = 0.56 √T/P28 + 0.28 √SW28 + 0.7 x ln (ESR) +0.014 x SGA. DAS28 score ranged from 0 to 10, where a higher score represented higher disease activity. A score of \<2.6 indicated disease activity remission. 1 participant in the Arm Placebo Q2WK / 210 mg AMG 827 Q2WK was missing baseline data for DAS28.
Time frame: Baseline of parent study 20090061 to Week 2, 4, 8, 12, 16, 20, 24, 36 and 48 of study 20090402.
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 16 | 1 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 12 | 2 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 4 | 1 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 36 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 8 | 1 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Baseline | 2 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | Parent Study 20090061 Baseline | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 24 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 20 | 1 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 2 | 0 Participants |
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 48 | 0 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 2 | 3 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | Parent Study 20090061 Baseline | 0 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Baseline | 2 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 24 | 1 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 4 | 4 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 8 | 3 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 12 | 6 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 16 | 4 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 20 | 2 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 36 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 20 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 36 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Baseline | 0 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 24 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 16 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 12 | 0 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 4 | 1 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | Parent Study 20090061 Baseline | 0 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 8 | 0 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 2 | 1 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 8 | 5 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 12 | 1 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 16 | 5 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Baseline | 2 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 36 | 1 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 20 | 1 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 24 | 2 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 4 | 1 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | Parent Study 20090061 Baseline | 0 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a DAS28 Score < 2.6 | 20090402 Week 2 | 1 Participants |
Primary
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as an event that occurred after the first dose date and before the end of study date in study 20090402; or an event that was already present prior to the initiation of the investigational product (i.e. present at study 20090402) baseline but worsened in either frequency or severity after the first dose date and before the end of study date in study 20090402. TEAEs also included serious treatment-emergent adverse events and clinically significant changes from baseline in hematology, chemistry and urinalysis profiles and clinically significant changes in vital sign measurements.
Time frame: Day 1 to Week 52 of study 20090402
Population: FAS - All analyzable participants who were treated with at least one dose of AMG 827.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 28 Participants |
| 70 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 32 Participants |
| 140mg AMG 827 Q2WK / 210mg AMG 827 Q2WK | Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 31 Participants |
| 210 mg AMG 827 Q2WK / 210 mg AMG 827 Q2WK | Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 32 Participants |