Rheumatoid Arthritis
Conditions
Keywords
Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921
Brief summary
This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.
Detailed description
Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.
Interventions
DRUGPlacebo
intravenous infusion on three consecutive months
DRUGdose level 1
intravenous infusion on three consecutive months
DRUGdose level 2
intravenous infusion on three consecutive months
DRUGdose level 3
intravenous infusion on three consecutive months
DRUGdose level 4
intravenous infusion on 3 consecutive months
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Rheumatoid Arthritis on a stable dose of methotrexate * Rheumatoid Arthritis disease activity as assessed by blood tests
Exclusion criteria
* Serious or uncontrolled medical conditions * Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab * Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Decay Half-Life (t1/2): Day 56 | Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose | Serum decay half-life is the time measured for the serum concentration to decrease by one half. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28 | Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose | AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168). |
| Maximum Observed Serum Concentration (Cmax): Day 56 | Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose | — |
| Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56 | Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56 | Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose | AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168). |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. |
| Number of Participants With Positive Anti-drug Antibodies Response | Day 1, 28, 56, 84, 174, 354, End of Study (Day 624) | — |
| Maximum Observed Serum Concentration (Cmax): Day 1 | Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose | — |
| Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1 | Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1 | Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose | AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168). |
| Maximum Observed Serum Concentration (Cmax): Day 28 | Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose | — |
| Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28 | Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Log CRP Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 | Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation | — |
| Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 | Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method. |
| Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra sensitive assay. A decrease in the level of CRP indicates reduction in inflammation. |
Countries
South Korea, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to PF-04236921 intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days. | 9 |
| PF-04236921 1 mg PF-04236921 1 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days. | 6 |
| PF-04236921 10 mg PF-04236921 10 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days. | 6 |
| PF-04236921 30 mg PF-04236921 30 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days. | 6 |
| PF-04236921 100 mg PF-04236921 100 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days. | 6 |
| PF-04236921 250 mg PF-04236921 250 mg intravenous infusion over approximately 1 hour on Day 1, 28 and 56. Methotrexate orally or parenterally starting from at least 16 weeks prior to randomization as per local standard-of-care practice followed by a stable dose of methotrexate between 7.5 to 25 mg per week from at least 6 weeks prior to randomization to Day 84. Participants were followed up to 624 days. | 7 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Other | 0 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Randomized but not Treated | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | PF-04236921 1 mg | PF-04236921 10 mg | PF-04236921 30 mg | PF-04236921 100 mg | PF-04236921 250 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.6 years STANDARD_DEVIATION 8.5 | 61.7 years STANDARD_DEVIATION 7.9 | 49.8 years STANDARD_DEVIATION 13.5 | 46.0 years STANDARD_DEVIATION 4.1 | 56.7 years STANDARD_DEVIATION 8.9 | 55.4 years STANDARD_DEVIATION 9.8 | 55.2 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 34 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 4 / 6 | 4 / 6 | 6 / 6 | 6 / 6 | 5 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 | 0 / 6 | 2 / 6 | 1 / 6 | 0 / 7 |
Outcome results
Primary
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1 | 1899 ng*day/mL | Standard Deviation 1090.1 |
| PF-04236921 1 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1 | 19570 ng*day/mL | Standard Deviation 5335.7 |
| PF-04236921 10 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1 | 54140 ng*day/mL | Standard Deviation 9345 |
| PF-04236921 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1 | 206000 ng*day/mL | Standard Deviation 40578 |
| PF-04236921 100 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1 | 348500 ng*day/mL | Standard Deviation 336540 |
Primary
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28 | 3104 ng*day/mL | Standard Deviation 2369.7 |
| PF-04236921 1 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28 | 21660 ng*day/mL | Standard Deviation 7232.7 |
| PF-04236921 10 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28 | 76510 ng*day/mL | Standard Deviation 19496 |
| PF-04236921 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28 | 316900 ng*day/mL | Standard Deviation 45597 |
| PF-04236921 100 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28 | 767900 ng*day/mL | Standard Deviation 213320 |
Primary
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56 | 3730 ng*day/mL | Standard Deviation 4479.8 |
| PF-04236921 1 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56 | 23200 ng*day/mL | Standard Deviation 7558.6 |
| PF-04236921 10 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56 | 101100 ng*day/mL | Standard Deviation 6438.2 |
| PF-04236921 30 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56 | 389100 ng*day/mL | Standard Deviation 71949 |
| PF-04236921 100 mg | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56 | 912200 ng*day/mL | Standard Deviation 209610 |
Primary
Maximum Observed Serum Concentration (Cmax): Day 1
Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Population: Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax): Day 1 | 421.6 nanogram per milliliter (ng/mL) | Standard Deviation 162.89 |
| PF-04236921 1 mg | Maximum Observed Serum Concentration (Cmax): Day 1 | 4631 nanogram per milliliter (ng/mL) | Standard Deviation 1429.9 |
| PF-04236921 10 mg | Maximum Observed Serum Concentration (Cmax): Day 1 | 11320 nanogram per milliliter (ng/mL) | Standard Deviation 2167.2 |
| PF-04236921 30 mg | Maximum Observed Serum Concentration (Cmax): Day 1 | 42290 nanogram per milliliter (ng/mL) | Standard Deviation 7883 |
| PF-04236921 100 mg | Maximum Observed Serum Concentration (Cmax): Day 1 | 66280 nanogram per milliliter (ng/mL) | Standard Deviation 59405 |
Primary
Maximum Observed Serum Concentration (Cmax): Day 28
Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax): Day 28 | 617.6 ng/mL | Standard Deviation 430.18 |
| PF-04236921 1 mg | Maximum Observed Serum Concentration (Cmax): Day 28 | 4719 ng/mL | Standard Deviation 1807.2 |
| PF-04236921 10 mg | Maximum Observed Serum Concentration (Cmax): Day 28 | 13680 ng/mL | Standard Deviation 3453.2 |
| PF-04236921 30 mg | Maximum Observed Serum Concentration (Cmax): Day 28 | 57280 ng/mL | Standard Deviation 6396.4 |
| PF-04236921 100 mg | Maximum Observed Serum Concentration (Cmax): Day 28 | 158300 ng/mL | Standard Deviation 50966 |
Primary
Maximum Observed Serum Concentration (Cmax): Day 56
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax): Day 56 | 741.0 ng/mL | Standard Deviation 977.35 |
| PF-04236921 1 mg | Maximum Observed Serum Concentration (Cmax): Day 56 | 4424 ng/mL | Standard Deviation 1384.8 |
| PF-04236921 10 mg | Maximum Observed Serum Concentration (Cmax): Day 56 | 19650 ng/mL | Standard Deviation 1537.5 |
| PF-04236921 30 mg | Maximum Observed Serum Concentration (Cmax): Day 56 | 64850 ng/mL | Standard Deviation 13289 |
| PF-04236921 100 mg | Maximum Observed Serum Concentration (Cmax): Day 56 | 164600 ng/mL | Standard Deviation 35644 |
Primary
Number of Participants With Positive Anti-drug Antibodies Response
Time frame: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Positive Anti-drug Antibodies Response | Day 1 | 0 participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies Response | End of Study | 0 participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies Response | Day 28 | 0 participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies Response | Day 56 | 0 participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies Response | Day 84 | 0 participants |
| Placebo | Number of Participants With Positive Anti-drug Antibodies Response | Day 174 | 0 participants |
| PF-04236921 1 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 56 | 0 participants |
| PF-04236921 1 mg | Number of Participants With Positive Anti-drug Antibodies Response | End of Study | 0 participants |
| PF-04236921 1 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 1 | 0 participants |
| PF-04236921 1 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 84 | 0 participants |
| PF-04236921 1 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 28 | 0 participants |
| PF-04236921 1 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 354 | 0 participants |
| PF-04236921 1 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 174 | 0 participants |
| PF-04236921 10 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 84 | 0 participants |
| PF-04236921 10 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 1 | 0 participants |
| PF-04236921 10 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 28 | 0 participants |
| PF-04236921 10 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 56 | 0 participants |
| PF-04236921 10 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 174 | 0 participants |
| PF-04236921 10 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 354 | 0 participants |
| PF-04236921 10 mg | Number of Participants With Positive Anti-drug Antibodies Response | End of Study | 0 participants |
| PF-04236921 30 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 56 | 0 participants |
| PF-04236921 30 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 174 | 0 participants |
| PF-04236921 30 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 28 | 0 participants |
| PF-04236921 30 mg | Number of Participants With Positive Anti-drug Antibodies Response | End of Study | 0 participants |
| PF-04236921 30 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 354 | 0 participants |
| PF-04236921 30 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 1 | 0 participants |
| PF-04236921 30 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 84 | 0 participants |
| PF-04236921 100 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 56 | 0 participants |
| PF-04236921 100 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 28 | 0 participants |
| PF-04236921 100 mg | Number of Participants With Positive Anti-drug Antibodies Response | End of Study | 0 participants |
| PF-04236921 100 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 354 | 0 participants |
| PF-04236921 100 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 174 | 0 participants |
| PF-04236921 100 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 1 | 0 participants |
| PF-04236921 100 mg | Number of Participants With Positive Anti-drug Antibodies Response | Day 84 | 0 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 9 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04236921 1 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| PF-04236921 1 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04236921 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| PF-04236921 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-04236921 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 participants |
| PF-04236921 30 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
| PF-04236921 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 participants |
| PF-04236921 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| PF-04236921 250 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 5 participants |
| PF-04236921 250 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
Primary
Serum Decay Half-Life (t1/2): Day 56
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo | Serum Decay Half-Life (t1/2): Day 56 | 45.50 days | — |
| PF-04236921 1 mg | Serum Decay Half-Life (t1/2): Day 56 | 36.90 days | Full Range 11.01 |
| PF-04236921 10 mg | Serum Decay Half-Life (t1/2): Day 56 | 45.30 days | Full Range 9.5166 |
| PF-04236921 30 mg | Serum Decay Half-Life (t1/2): Day 56 | 38.80 days | Full Range 6.95 |
| PF-04236921 100 mg | Serum Decay Half-Life (t1/2): Day 56 | 51.70 days | Full Range 9.223 |
Primary
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1
Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1 | 0.0521 days |
| PF-04236921 1 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1 | 0.0521 days |
| PF-04236921 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1 | 0.0521 days |
| PF-04236921 30 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1 | 0.0521 days |
| PF-04236921 100 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1 | 0.0521 days |
Primary
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28 | 0.0521 days |
| PF-04236921 1 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28 | 0.0521 days |
| PF-04236921 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28 | 0.0521 days |
| PF-04236921 30 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28 | 0.0521 days |
| PF-04236921 100 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28 | 0.0521 days |
Primary
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Population: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56 | 0.0521 days |
| PF-04236921 1 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56 | 0.0521 days |
| PF-04236921 10 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56 | 0.0521 days |
| PF-04236921 30 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56 | 0.0521 days |
| PF-04236921 100 mg | Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56 | 0.0521 days |
Other Pre-specified
Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation
Time frame: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
Population: Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter.Data collected at Early Discontinuation included those subjects who left the study early. 'N' (number of participants analyzed) = participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | 0.49 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.085 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Early Discontinuation | 0.00 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.498 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | 0.34 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.987 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | 0.49 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.222 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 3.41 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.458 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | 0.48 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.842 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 579 | 0.16 10^3 cells/millimeter (mm)^3 | — |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | 1.56 10^3 cells/millimeter (mm)^3 | Standard Deviation 2.271 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | 0.34 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.919 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | 0.47 10^3 cells/millimeter (mm)^3 | — |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | 0.05 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.452 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -0.05 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.427 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | 0.57 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.883 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 489 | 0.68 10^3 cells/millimeter (mm)^3 | — |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | 1.46 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.296 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | 0.27 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.932 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | 0.44 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.922 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | 0.69 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.653 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | 0.24 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.632 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | 0.69 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.071 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -0.45 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.683 |
| Placebo | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -0.10 10^3 cells/millimeter (mm)^3 | — |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -0.87 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.257 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -1.48 10^3 cells/millimeter (mm)^3 | — |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -0.71 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.145 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 4.13 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.161 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Early Discontinuation | 0.93 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.106 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -0.58 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.828 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -0.39 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.394 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -0.67 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.834 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -0.79 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.071 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -1.17 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.742 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -1.18 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.054 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -0.16 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.707 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -0.35 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.289 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -0.51 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.944 |
| PF-04236921 1 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -0.99 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.994 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 4.35 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.203 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -1.75 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.024 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -0.56 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.278 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -1.27 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.468 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -1.36 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.548 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -1.34 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.586 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -1.80 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.952 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Early Discontinuation | -1.00 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.899 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -2.61 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.709 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -1.11 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.111 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -1.77 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.138 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -1.61 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.936 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -2.02 10^3 cells/millimeter (mm)^3 | — |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -1.40 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.424 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -0.87 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.969 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -1.19 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.763 |
| PF-04236921 10 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -1.92 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.051 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | -0.61 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.781 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 4.38 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.791 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -1.28 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.574 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -0.33 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.74 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -0.75 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.876 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -1.11 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.682 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Early Discontinuation | -0.69 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.087 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -0.66 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.764 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -0.61 10^3 cells/millimeter (mm)^3 | — |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -1.28 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.857 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -0.88 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.448 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -1.23 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.872 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -0.70 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.899 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -0.54 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.094 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -1.34 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.726 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -0.09 10^3 cells/millimeter (mm)^3 | Standard Deviation 2.183 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -0.84 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.005 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -0.48 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.746 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -0.61 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.756 |
| PF-04236921 30 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | -0.32 10^3 cells/millimeter (mm)^3 | — |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 489 | -1.24 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.564 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 4.26 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.058 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -1.91 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.66 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -1.91 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.46 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -2.08 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.756 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -1.78 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.954 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -1.47 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.778 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -1.69 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.979 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -2.20 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.218 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -1.02 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.858 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -1.62 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.757 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -1.25 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.254 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -1.71 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.906 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -1.36 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.237 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -1.01 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.99 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -1.33 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.624 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | 0.34 10^3 cells/millimeter (mm)^3 | Standard Deviation 2.056 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | -0.96 10^3 cells/millimeter (mm)^3 | Standard Deviation 2.067 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -1.87 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.55 |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -1.07 10^3 cells/millimeter (mm)^3 | — |
| PF-04236921 100 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Early Discontinuation | -0.63 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.849 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -0.60 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.458 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -0.78 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.588 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | -0.11 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.901 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -1.24 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.719 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -1.11 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.871 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -1.08 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.671 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | 0.11 10^3 cells/millimeter (mm)^3 | Standard Deviation 1.064 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -1.04 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.657 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 3.13 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.95 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 489 | 0.05 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.769 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -1.27 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.674 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -0.83 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.617 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Early Discontinuation | -0.07 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.948 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -0.22 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.685 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -0.70 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.859 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 579 | 0.41 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.566 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 624 | 0.10 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.792 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -0.42 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.726 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -0.64 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.683 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -0.82 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.667 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -0.60 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.637 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -0.16 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.717 |
| PF-04236921 250 mg | Change From Baseline in Absolute Neutrophil Counts at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -0.58 10^3 cells/millimeter (mm)^3 | Standard Deviation 0.254 |
Other Pre-specified
Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra sensitive assay. A decrease in the level of CRP indicates reduction in inflammation.
Time frame: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624, Early Discontinuation
Population: Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Data collected at Early Discontinuation included those subjects who left the study early.'N' (number of participants analyzed) = participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 579 | -13.88 milligram per liter (mg/L) | — |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -0.09 milligram per liter (mg/L) | Standard Deviation 7.128 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -3.33 milligram per liter (mg/L) | Standard Deviation 12.217 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | 0.74 milligram per liter (mg/L) | Standard Deviation 6.859 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | 2.42 milligram per liter (mg/L) | Standard Deviation 15.773 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -0.06 milligram per liter (mg/L) | Standard Deviation 6.823 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -6.82 milligram per liter (mg/L) | — |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -6.19 milligram per liter (mg/L) | Standard Deviation 7.987 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -0.10 milligram per liter (mg/L) | Standard Deviation 8.214 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | 5.10 milligram per liter (mg/L) | Standard Deviation 23.998 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | 5.16 milligram per liter (mg/L) | Standard Deviation 26.869 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 11.54 milligram per liter (mg/L) | Standard Deviation 12.452 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -2.63 milligram per liter (mg/L) | Standard Deviation 10.877 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | 1.68 milligram per liter (mg/L) | Standard Deviation 13.334 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -5.33 milligram per liter (mg/L) | Standard Deviation 6.033 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | 4.35 milligram per liter (mg/L) | Standard Deviation 18.53 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | -15.00 milligram per liter (mg/L) | — |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | -2.49 milligram per liter (mg/L) | Standard Deviation 8.119 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | 1.06 milligram per liter (mg/L) | Standard Deviation 5.153 |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 489 | -14.38 milligram per liter (mg/L) | — |
| Placebo | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -0.07 milligram per liter (mg/L) | Standard Deviation 6.724 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -6.60 milligram per liter (mg/L) | Standard Deviation 8.299 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -4.55 milligram per liter (mg/L) | Standard Deviation 0.735 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -6.23 milligram per liter (mg/L) | Standard Deviation 9.13 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -8.49 milligram per liter (mg/L) | Standard Deviation 10.327 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -5.81 milligram per liter (mg/L) | Standard Deviation 9.019 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 9.95 milligram per liter (mg/L) | Standard Deviation 7.886 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -4.48 milligram per liter (mg/L) | Standard Deviation 8.635 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -6.51 milligram per liter (mg/L) | Standard Deviation 8.817 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -6.30 milligram per liter (mg/L) | — |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -6.14 milligram per liter (mg/L) | Standard Deviation 8.918 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -6.36 milligram per liter (mg/L) | Standard Deviation 8.322 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -7.83 milligram per liter (mg/L) | Standard Deviation 8.284 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | 4.01 milligram per liter (mg/L) | Standard Deviation 10.083 |
| PF-04236921 1 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -7.67 milligram per liter (mg/L) | Standard Deviation 8.263 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -9.85 milligram per liter (mg/L) | Standard Deviation 5.83 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -9.98 milligram per liter (mg/L) | Standard Deviation 6.168 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -11.25 milligram per liter (mg/L) | Standard Deviation 6.74 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -10.68 milligram per liter (mg/L) | Standard Deviation 6.503 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -10.88 milligram per liter (mg/L) | Standard Deviation 6.555 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -10.03 milligram per liter (mg/L) | Standard Deviation 6.134 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -6.22 milligram per liter (mg/L) | Standard Deviation 4.79 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -10.26 milligram per liter (mg/L) | Standard Deviation 5.772 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -8.73 milligram per liter (mg/L) | Standard Deviation 4.55 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -11.35 milligram per liter (mg/L) | Standard Deviation 6.758 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -4.36 milligram per liter (mg/L) | Standard Deviation 1.761 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -11.10 milligram per liter (mg/L) | Standard Deviation 6.617 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 11.01 milligram per liter (mg/L) | Standard Deviation 6.419 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -11.02 milligram per liter (mg/L) | Standard Deviation 6.653 |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -2.30 milligram per liter (mg/L) | — |
| PF-04236921 10 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -4.06 milligram per liter (mg/L) | Standard Deviation 1.961 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | -0.79 milligram per liter (mg/L) | — |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 7.23 milligram per liter (mg/L) | Standard Deviation 8.316 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -6.43 milligram per liter (mg/L) | Standard Deviation 7.766 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -6.69 milligram per liter (mg/L) | Standard Deviation 8.357 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -6.70 milligram per liter (mg/L) | Standard Deviation 8.402 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -6.52 milligram per liter (mg/L) | Standard Deviation 8.515 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -6.82 milligram per liter (mg/L) | Standard Deviation 8.384 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -6.65 milligram per liter (mg/L) | Standard Deviation 8.453 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -6.67 milligram per liter (mg/L) | Standard Deviation 8.472 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -6.82 milligram per liter (mg/L) | Standard Deviation 8.441 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -6.88 milligram per liter (mg/L) | Standard Deviation 8.441 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -6.63 milligram per liter (mg/L) | Standard Deviation 8.513 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -4.28 milligram per liter (mg/L) | Standard Deviation 4.545 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -6.40 milligram per liter (mg/L) | Standard Deviation 8.602 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -2.58 milligram per liter (mg/L) | Standard Deviation 1.056 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -5.80 milligram per liter (mg/L) | Standard Deviation 8.951 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -5.11 milligram per liter (mg/L) | Standard Deviation 9.482 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | -6.47 milligram per liter (mg/L) | Standard Deviation 8.596 |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 489 | -1.05 milligram per liter (mg/L) | — |
| PF-04236921 30 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -0.86 milligram per liter (mg/L) | — |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -2.34 milligram per liter (mg/L) | — |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -8.68 milligram per liter (mg/L) | Standard Deviation 5.812 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -8.66 milligram per liter (mg/L) | Standard Deviation 5.807 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -8.66 milligram per liter (mg/L) | Standard Deviation 5.817 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -8.65 milligram per liter (mg/L) | Standard Deviation 5.833 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -8.07 milligram per liter (mg/L) | Standard Deviation 5.922 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -8.63 milligram per liter (mg/L) | Standard Deviation 5.824 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -7.63 milligram per liter (mg/L) | Standard Deviation 6.599 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -8.59 milligram per liter (mg/L) | Standard Deviation 5.797 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 8.88 milligram per liter (mg/L) | Standard Deviation 5.797 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -8.12 milligram per liter (mg/L) | Standard Deviation 5.849 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | 4.68 milligram per liter (mg/L) | Standard Deviation 32.401 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -8.56 milligram per liter (mg/L) | Standard Deviation 5.827 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | -4.78 milligram per liter (mg/L) | Standard Deviation 4.694 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -8.26 milligram per liter (mg/L) | Standard Deviation 5.747 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 489 | -1.80 milligram per liter (mg/L) | Standard Deviation 0.87 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -8.65 milligram per liter (mg/L) | Standard Deviation 5.84 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -8.54 milligram per liter (mg/L) | Standard Deviation 5.76 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -8.69 milligram per liter (mg/L) | Standard Deviation 5.81 |
| PF-04236921 100 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -8.57 milligram per liter (mg/L) | Standard Deviation 5.781 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 624 | -23.45 milligram per liter (mg/L) | Standard Deviation 37.575 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Baseline | 17.91 milligram per liter (mg/L) | Standard Deviation 25.572 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 354 | -16.61 milligram per liter (mg/L) | Standard Deviation 28.313 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 14 | -17.52 milligram per liter (mg/L) | Standard Deviation 25.571 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 63 | -17.58 milligram per liter (mg/L) | Standard Deviation 25.611 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 579 | -15.81 milligram per liter (mg/L) | Standard Deviation 28.62 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 56 | -17.59 milligram per liter (mg/L) | Standard Deviation 25.611 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Early Discontinuation | 2.30 milligram per liter (mg/L) | — |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 84 | -17.58 milligram per liter (mg/L) | Standard Deviation 25.587 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 219 | -19.43 milligram per liter (mg/L) | Standard Deviation 26.221 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 399 | -16.56 milligram per liter (mg/L) | Standard Deviation 28.33 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 42 | -17.59 milligram per liter (mg/L) | Standard Deviation 25.614 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 489 | -16.47 milligram per liter (mg/L) | Standard Deviation 28.357 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 174 | -17.62 milligram per liter (mg/L) | Standard Deviation 25.581 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 7 | -17.31 milligram per liter (mg/L) | Standard Deviation 25.317 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 264 | -16.60 milligram per liter (mg/L) | Standard Deviation 28.318 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 35 | -17.56 milligram per liter (mg/L) | Standard Deviation 25.608 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 70 | -17.60 milligram per liter (mg/L) | Standard Deviation 25.608 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 534 | -16.25 milligram per liter (mg/L) | Standard Deviation 28.463 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 444 | -15.57 milligram per liter (mg/L) | Standard Deviation 28.927 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 309 | -16.52 milligram per liter (mg/L) | Standard Deviation 28.364 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 28 | -17.52 milligram per liter (mg/L) | Standard Deviation 25.634 |
| PF-04236921 250 mg | Change From Baseline in C-Reactive Protein (CRP) Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624 and Early Discontinuation | Change at Day 129 | -17.66 milligram per liter (mg/L) | Standard Deviation 25.605 |
Other Pre-specified
Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624
Serum samples were analyzed for IL-6 concentrations using a validated analytical colorimetric Enzyme-Linked Immunosorbent Assay (ELISA) method.
Time frame: Baseline, Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
Population: Pharmacodynamic analysis set included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. n=participants evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 534 | -4.08 picogram per milliliter (pg/mL) | — |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 219 | 4.51 picogram per milliliter (pg/mL) | Standard Deviation 19.163 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 28 | 0.45 picogram per milliliter (pg/mL) | Standard Deviation 5.383 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 264 | -2.33 picogram per milliliter (pg/mL) | Standard Deviation 14.034 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 489 | -4.08 picogram per milliliter (pg/mL) | — |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 56 | -2.00 picogram per milliliter (pg/mL) | Standard Deviation 8.081 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 444 | -4.08 picogram per milliliter (pg/mL) | — |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 399 | -1.36 picogram per milliliter (pg/mL) | Standard Deviation 2.356 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 84 | -0.04 picogram per milliliter (pg/mL) | Standard Deviation 14.524 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Baseline | 12.55 picogram per milliliter (pg/mL) | Standard Deviation 14.593 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 354 | -1.36 picogram per milliliter (pg/mL) | Standard Deviation 2.356 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 129 | -1.25 picogram per milliliter (pg/mL) | Standard Deviation 8.691 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 579 | -4.08 picogram per milliliter (pg/mL) | — |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 309 | -1.36 picogram per milliliter (pg/mL) | Standard Deviation 2.356 |
| Placebo | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 174 | 4.53 picogram per milliliter (pg/mL) | Standard Deviation 20.905 |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 264 | -17.94 picogram per milliliter (pg/mL) | — |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 28 | -2.16 picogram per milliliter (pg/mL) | Standard Deviation 5.767 |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 84 | -5.60 picogram per milliliter (pg/mL) | Standard Deviation 7.278 |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Baseline | 9.11 picogram per milliliter (pg/mL) | Standard Deviation 7.204 |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 219 | -2.51 picogram per milliliter (pg/mL) | Standard Deviation 16.794 |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 174 | -4.70 picogram per milliliter (pg/mL) | Standard Deviation 14.863 |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 56 | -3.04 picogram per milliliter (pg/mL) | Standard Deviation 6.583 |
| PF-04236921 1 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 129 | -1.90 picogram per milliliter (pg/mL) | Standard Deviation 9.291 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 309 | -9.19 picogram per milliliter (pg/mL) | Standard Deviation 18.993 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Baseline | 17.82 picogram per milliliter (pg/mL) | Standard Deviation 12.433 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 56 | -16.14 picogram per milliliter (pg/mL) | Standard Deviation 12.643 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 129 | -13.39 picogram per milliliter (pg/mL) | Standard Deviation 13.627 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 264 | -1.03 picogram per milliliter (pg/mL) | Standard Deviation 17.395 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 219 | -14.23 picogram per milliliter (pg/mL) | Standard Deviation 13.524 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 84 | -14.96 picogram per milliliter (pg/mL) | Standard Deviation 14.406 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 174 | -11.63 picogram per milliliter (pg/mL) | Standard Deviation 12.903 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 28 | -13.12 picogram per milliliter (pg/mL) | Standard Deviation 13.086 |
| PF-04236921 10 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 354 | -20.00 picogram per milliliter (pg/mL) | — |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 489 | -2.51 picogram per milliliter (pg/mL) | — |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Baseline | 3.96 picogram per milliliter (pg/mL) | Standard Deviation 3.272 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 28 | -2.40 picogram per milliliter (pg/mL) | Standard Deviation 3.272 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 56 | -1.80 picogram per milliliter (pg/mL) | Standard Deviation 3.342 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 84 | -2.08 picogram per milliliter (pg/mL) | Standard Deviation 3.623 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 129 | -1.89 picogram per milliliter (pg/mL) | Standard Deviation 3.907 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 174 | -1.34 picogram per milliliter (pg/mL) | Standard Deviation 4.056 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 219 | -0.77 picogram per milliliter (pg/mL) | Standard Deviation 3.83 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 264 | -1.39 picogram per milliliter (pg/mL) | Standard Deviation 2.609 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 309 | -1.67 picogram per milliliter (pg/mL) | Standard Deviation 2.506 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 354 | -2.34 picogram per milliliter (pg/mL) | Standard Deviation 3.487 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 399 | 2.15 picogram per milliliter (pg/mL) | Standard Deviation 4.508 |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 444 | 4.69 picogram per milliliter (pg/mL) | — |
| PF-04236921 30 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 534 | -2.51 picogram per milliliter (pg/mL) | — |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 264 | -9.93 picogram per milliliter (pg/mL) | Standard Deviation 9.856 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 129 | -10.19 picogram per milliliter (pg/mL) | Standard Deviation 9.797 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 534 | -20.93 picogram per milliliter (pg/mL) | — |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 309 | -8.87 picogram per milliliter (pg/mL) | Standard Deviation 10.655 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 84 | -10.19 picogram per milliliter (pg/mL) | Standard Deviation 9.797 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 354 | -8.61 picogram per milliliter (pg/mL) | Standard Deviation 10.701 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Baseline | 11.75 picogram per milliliter (pg/mL) | Standard Deviation 9.797 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 399 | -3.74 picogram per milliliter (pg/mL) | Standard Deviation 17.157 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 56 | -10.19 picogram per milliliter (pg/mL) | Standard Deviation 9.797 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 444 | -8.19 picogram per milliliter (pg/mL) | Standard Deviation 12.557 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 28 | -9.70 picogram per milliliter (pg/mL) | Standard Deviation 9.147 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 489 | -6.31 picogram per milliliter (pg/mL) | Standard Deviation 19.778 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 219 | -10.19 picogram per milliliter (pg/mL) | Standard Deviation 9.797 |
| PF-04236921 100 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 174 | -10.19 picogram per milliliter (pg/mL) | Standard Deviation 9.797 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 399 | -1.33 picogram per milliliter (pg/mL) | Standard Deviation 1.905 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 219 | -3.89 picogram per milliliter (pg/mL) | Standard Deviation 7.796 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 579 | -1.33 picogram per milliliter (pg/mL) | Standard Deviation 1.905 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 129 | -7.16 picogram per milliliter (pg/mL) | Standard Deviation 11.507 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 624 | -0.85 picogram per milliliter (pg/mL) | Standard Deviation 1.472 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 444 | -0.78 picogram per milliliter (pg/mL) | Standard Deviation 1.865 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 174 | -7.22 picogram per milliliter (pg/mL) | Standard Deviation 11.332 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 309 | -1.33 picogram per milliliter (pg/mL) | Standard Deviation 1.905 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 84 | -7.29 picogram per milliliter (pg/mL) | Standard Deviation 11.313 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 28 | -7.25 picogram per milliliter (pg/mL) | Standard Deviation 10.337 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 534 | -1.33 picogram per milliliter (pg/mL) | Standard Deviation 1.905 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 264 | -1.33 picogram per milliliter (pg/mL) | Standard Deviation 1.905 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 354 | -1.33 picogram per milliliter (pg/mL) | Standard Deviation 1.905 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 56 | -7.93 picogram per milliliter (pg/mL) | Standard Deviation 11.744 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Change at Day 489 | -0.44 picogram per milliliter (pg/mL) | Standard Deviation 2.157 |
| PF-04236921 250 mg | Change From Baseline in Free Interleukin-6 (IL-6) Concentrations at Day 28, 56, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579 and 624 | Baseline | 9.49 picogram per milliliter (pg/mL) | Standard Deviation 11.744 |
Other Pre-specified
Change From Baseline in Log CRP Concentrations at Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Day 7, 14, 28, 35, 42, 56, 63, 70, 84, 129, 174, 219, 264, 309, 354, 399, 444, 489, 534, 579, 624
Population: Data for this outcome measure was not assessed since this measure was analyzed as per sponsor discretion as the change from baseline in CRP in this study was well demonstrated with the raw CRP data. Therefore, log transformation of CRP was not performed.