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Trial record 1 of 1 for:    NCT00838565
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Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00838565
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Rheumatoid Arthritis
Interventions Drug: Placebo
Drug: dose level 1
Drug: dose level 2
Drug: dose level 3
Drug: dose level 4
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
Started 9 7 6 6 6 7
Treated 9 6 6 6 6 7
Completed 9 4 5 6 6 5
Not Completed 0 3 1 0 0 2
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             2
Other             0             2             0             0             0             0
Randomized but not Treated             0             1             0             0             0             0
Arm/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 9 6 6 6 6 7 40
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 6 participants 6 participants 6 participants 6 participants 7 participants 40 participants
59.6  (8.5) 61.7  (7.9) 49.8  (13.5) 46.0  (4.1) 56.7  (8.9) 55.4  (9.8) 55.2  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 6 participants 6 participants 6 participants 7 participants 40 participants
Female
8
  88.9%
6
 100.0%
5
  83.3%
5
  83.3%
4
  66.7%
6
  85.7%
34
  85.0%
Male
1
  11.1%
0
   0.0%
1
  16.7%
1
  16.7%
2
  33.3%
1
  14.3%
6
  15.0%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication.
Arm/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 9 6 6 6 6 7
Measure Type: Number
Unit of Measure: participants
AEs 9 4 4 6 6 5
SAEs 0 0 0 2 1 0
2.Primary Outcome
Title Number of Participants With Positive Anti-drug Antibodies Response
Hide Description [Not Specified]
Time Frame Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 6 6 7
Measure Type: Number
Unit of Measure: participants
Day 1 Number Analyzed 6 participants 6 participants 6 participants 6 participants 7 participants
0 0 0 0 0
Day 28 Number Analyzed 6 participants 5 participants 6 participants 6 participants 7 participants
0 0 0 0 0
Day 56 Number Analyzed 6 participants 5 participants 6 participants 6 participants 7 participants
0 0 0 0 0
Day 84 Number Analyzed 6 participants 5 participants 6 participants 6 participants 7 participants
0 0 0 0 0
Day 174 Number Analyzed 2 participants 5 participants 4 participants 6 participants 7 participants
0 0 0 0 0
Day 354 Number Analyzed 0 participants 1 participants 5 participants 6 participants 5 participants
0 0 0 0
End of Study Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants
0 0 0 0 0
3.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax): Day 1
Hide Description [Not Specified]
Time Frame Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 6 6 7
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
421.6  (162.89) 4631  (1429.9) 11320  (2167.2) 42290  (7883.0) 66280  (59405)
4.Primary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1
Hide Description [Not Specified]
Time Frame Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 6 6 7
Median (Full Range)
Unit of Measure: days
0.0521
(0.0521 to 0.0528)
0.0521
(0.0521 to 0.0521)
0.0521
(0.0521 to 0.0521)
0.0521
(0.0278 to 0.0521)
0.0521
(0.0521 to 0.0528)
5.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.
Arm/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 6 6 6 7
Geometric Mean (Standard Deviation)
Unit of Measure: ng*day/mL
1899  (1090.1) 19570  (5335.7) 54140  (9345.0) 206000  (40578) 348500  (336540)
6.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax): Day 28
Hide Description [Not Specified]
Time Frame Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 5 6 6 7
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
617.6  (430.18) 4719  (1807.2) 13680  (3453.2) 57280  (6396.4) 158300  (50966)
7.Primary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
Hide Description [Not Specified]
Time Frame Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 5 6 6 7
Median (Full Range)
Unit of Measure: days
0.0521
(0.0521 to 0.0528)
0.0521
(0.0521 to 0.0521)
0.0521
(0.0521 to 0.0521)
0.0521
(0.0521 to 0.0528)
0.0521
(0.0514 to 0.0521)
8.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 5 6 6 7
Geometric Mean (Standard Deviation)
Unit of Measure: ng*day/mL
3104  (2369.7) 21660  (7232.7) 76510  (19496) 316900  (45597) 767900  (213320)
9.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax): Day 56
Hide Description [Not Specified]
Time Frame Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 5 6 6 7
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
741.0  (977.35) 4424  (1384.8) 19650  (1537.5) 64850  (13289) 164600  (35644)
10.Primary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
Hide Description [Not Specified]
Time Frame Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 5 6 6 7
Median (Full Range)
Unit of Measure: days
0.0521
(0.0521 to 0.0542)
0.0521
(0.0521 to 0.0521)
0.0521
(0.0521 to 0.0521)
0.0521
(0.0521 to 0.0521)
0.0521
(0.0521 to 0.0528)
11.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 6 5 6 6 7
Geometric Mean (Standard Deviation)
Unit of Measure: ng*day/mL
3730  (4479.8) 23200  (7558.6) 101100  (6438.2) 389100  (71949) 912200  (209610)
12.Primary Outcome
Title Serum Decay Half-Life (t1/2): Day 56
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 2 5 5 6 6
Median (Full Range)
Unit of Measure: days
45.50
(45.0 to 46.0)
36.90
(19.3 to 49.5)
45.30
(32.9 to 54.3)
38.80
(35.5 to 51.7)
51.70
(31.9 to 59.2)
13.Other Pre-specified Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 9 6 6 5 6 7
Mean (Standard Deviation)
Unit of Measure: milligram per liter (mg/L)
Baseline Number Analyzed 9 participants 6 participants 6 participants 5 participants 6 participants 7 participants
11.54  (12.452) 9.95  (7.886) 11.01  (6.419) 7.23  (8.316) 8.88  (5.797) 17.91  (25.572)
Change at Day 7 Number Analyzed 9 participants 6 participants 6 participants 5 participants 6 participants 7 participants
-0.09  (7.128) -6.36  (8.322) -9.85  (5.830) -6.43  (7.766) -8.26  (5.747) -17.31  (25.317)
Change at Day 14 Number Analyzed 9 participants 6 participants 6 participants 5 participants 6 participants 7 participants
-2.63  (10.877) -5.81  (9.019) -10.03  (6.134) -6.69  (8.357) -8.56  (5.827) -17.52  (25.571)
Change at Day 28 Number Analyzed 9 participants 6 participants 5 participants 5 participants 6 participants 7 participants
1.06  (5.153) -4.48  (8.635) -9.98  (6.168) -6.70  (8.402) -8.59  (5.797) -17.52  (25.634)
Change at Day 35 Number Analyzed 9 participants 6 participants 5 participants 5 participants 6 participants 7 participants
0.74  (6.859) -6.51  (8.817) -11.10  (6.617) -6.52  (8.515) -8.63  (5.824) -17.56  (25.608)
Change at Day 42 Number Analyzed 9 participants 6 participants 5 participants 5 participants 6 participants 7 participants
-0.06  (6.823) -6.60  (8.299) -11.02  (6.653) -6.82  (8.384) -8.65  (5.833) -17.59  (25.614)
Change at Day 56 Number Analyzed 9 participants 6 participants 5 participants 5 participants 6 participants 7 participants
-0.07  (6.724) -6.14  (8.918) -10.68  (6.503) -6.65  (8.453) -8.66  (5.817) -17.59  (25.611)
Change at Day 63 Number Analyzed 9 participants 6 participants 5 participants 5 participants 6 participants 7 participants
-0.10  (8.214) -7.83  (8.284) -11.35  (6.758) -6.67  (8.472) -8.68  (5.812) -17.58  (25.611)
Change at Day 70 Number Analyzed 9 participants 6 participants 5 participants 5 participants 6 participants 7 participants
1.68  (13.334) -7.67  (8.263) -11.25  (6.740) -6.82  (8.441) -8.69  (5.810) -17.60  (25.608)
Change at Day 84 Number Analyzed 9 participants 6 participants 5 participants 5 participants 6 participants 7 participants
5.16  (26.869) -6.23  (9.130) -10.88  (6.555) -6.88  (8.441) -8.54  (5.760) -17.58  (25.587)
Change at Day 129 Number Analyzed 8 participants 4 participants 5 participants 5 participants 6 participants 7 participants
5.10  (23.998) -8.49  (10.327) -10.26  (5.772) -6.63  (8.513) -8.65  (5.840) -17.66  (25.605)
Change at Day 174 Number Analyzed 7 participants 2 participants 5 participants 5 participants 6 participants 7 participants
2.42  (15.773) -4.55  (0.735) -8.73  (4.550) -4.28  (4.545) -8.57  (5.781) -17.62  (25.581)
Change at Day 219 Number Analyzed 7 participants 2 participants 5 participants 5 participants 6 participants 6 participants
4.35  (18.530) 4.01  (10.083) -6.22  (4.790) -6.40  (8.602) -8.66  (5.807) -19.43  (26.221)
Change at Day 264 Number Analyzed 6 participants 1 participants 3 participants 4 participants 6 participants 5 participants
-5.33  (6.033) -6.30 [1]   (NA) -4.06  (1.961) -2.58  (1.056) -8.07  (5.922) -16.60  (28.318)
Change at Day 309 Number Analyzed 3 participants 0 participants 2 participants 5 participants 6 participants 5 participants
-6.19  (7.987) -4.36  (1.761) -5.80  (8.951) -7.63  (6.599) -16.52  (28.364)
Change at Day 354 Number Analyzed 3 participants 0 participants 1 participants 5 participants 6 participants 5 participants
-3.33  (12.217) -2.30 [1]   (NA) -5.11  (9.482) -8.12  (5.849) -16.61  (28.313)
Change at Day 399 Number Analyzed 3 participants 0 participants 0 participants 3 participants 6 participants 5 participants
-2.49  (8.119) -6.47  (8.596) 4.68  (32.401) -16.56  (28.330)
Change at Day 444 Number Analyzed 1 participants 0 participants 0 participants 1 participants 3 participants 5 participants
-15.00 [1]   (NA) -0.79 [1]   (NA) -4.78  (4.694) -15.57  (28.927)
Change at Day 489 Number Analyzed 1 participants 0 participants 0 participants 1 participants 2 participants 5 participants
-14.38 [1]   (NA) -1.05 [1]   (NA) -1.80  (0.870) -16.47  (28.357)
Change at Day 534 Number Analyzed 1 participants 0 participants 0 participants 1 participants 1 participants 5 participants
-6.82 [1]   (NA) -0.86 [1]   (NA) -2.34 [1]   (NA) -16.25  (28.463)
Change at Day 579 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 5 participants
-13.88 [1]   (NA) -15.81  (28.620)
Change at Day 624 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants
-23.45  (37.575)
Change at Early Discontinuation Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
2.30 [1]   (NA)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
14.Other Pre-specified Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Other Pre-specified Outcome
Title 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
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 8 5 6 6 5 7
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/millimeter (mm)^3
Baseline Number Analyzed 8 participants 5 participants 6 participants 6 participants 5 participants 7 participants
3.41  (1.458) 4.13  (1.161) 4.35  (1.203) 4.38  (1.791) 4.26  (1.058) 3.13  (0.950)
Change at Day 7 Number Analyzed 8 participants 5 participants 6 participants 6 participants 5 participants 7 participants
0.27  (0.932) -0.16  (1.707) -1.61  (0.936) -0.61  (0.756) -1.87  (0.550) -1.08  (0.671)
Change at Day 14 Number Analyzed 8 participants 5 participants 6 participants 6 participants 5 participants 7 participants
0.34  (0.919) -0.71  (1.145) -1.34  (0.586) -0.70  (0.899) -1.91  (0.660) -0.78  (0.588)
Change at Day 28 Number Analyzed 8 participants 5 participants 5 participants 6 participants 5 participants 7 participants
0.24  (0.632) -0.58  (1.828) -0.56  (1.278) -0.66  (0.764) -1.91  (0.460) -0.60  (0.637)
Change at Day 35 Number Analyzed 8 participants 5 participants 5 participants 6 participants 5 participants 7 participants
0.34  (0.987) -0.39  (1.394) -1.92  (1.051) -1.28  (0.574) -2.08  (0.756) -0.70  (0.859)
Change at Day 42 Number Analyzed 8 participants 5 participants 5 participants 6 participants 5 participants 7 participants
0.48  (0.842) -0.67  (1.834) -1.19  (0.763) -0.54  (1.094) -1.78  (0.954) -0.83  (0.617)
Change at Day 56 Number Analyzed 8 participants 5 participants 5 participants 5 participants 4 participants 7 participants
0.49  (1.085) -0.79  (1.071) -1.75  (1.024) -1.11  (0.682) -1.47  (0.778) -1.27  (0.674)
Change at Day 63 Number Analyzed 8 participants 5 participants 5 participants 6 participants 5 participants 7 participants
-0.45  (1.683) -1.17  (1.742) -1.36  (0.548) -1.23  (0.872) -1.69  (0.979) -1.04  (0.657)
Change at Day 70 Number Analyzed 8 participants 5 participants 5 participants 5 participants 5 participants 7 participants
0.57  (0.883) -1.18  (1.054) -1.80  (0.952) -0.48  (0.746) -2.20  (1.218) -1.11  (0.871)
Change at Day 84 Number Analyzed 7 participants 5 participants 5 participants 6 participants 5 participants 7 participants
-0.05  (0.427) -0.87  (1.257) -1.77  (1.138) -0.33  (1.740) -1.02  (1.858) -1.24  (0.719)
Change at Day 129 Number Analyzed 7 participants 4 participants 4 participants 5 participants 5 participants 7 participants
1.56  (2.271) -0.35  (0.289) -1.40  (1.424) -0.84  (1.005) -1.62  (0.757) -0.60  (0.458)
Change at Day 174 Number Analyzed 6 participants 2 participants 5 participants 6 participants 5 participants 7 participants
0.49  (1.222) -0.51  (1.944) -1.27  (1.468) -0.09  (2.183) -1.25  (1.254) -0.58  (0.254)
Change at Day 219 Number Analyzed 6 participants 2 participants 5 participants 6 participants 5 participants 6 participants
0.69  (1.071) -0.99  (0.994) -1.11  (1.111) -0.75  (0.876) -1.71  (0.906) -0.82  (0.667)
Change at Day 264 Number Analyzed 5 participants 1 participants 3 participants 5 participants 5 participants 5 participants
0.69  (0.653) -1.48 [1]   (NA) -0.87  (0.969) -1.28  (0.857) -1.36  (1.237) -0.64  (0.683)
Change at Day 309 Number Analyzed 2 participants 0 participants 2 participants 5 participants 5 participants 3 participants
0.05  (0.452) -2.61  (0.709) -1.34  (0.726) -1.01  (0.990) -0.42  (0.726)
Change at Day 354 Number Analyzed 2 participants 0 participants 1 participants 5 participants 5 participants 5 participants
1.46  (0.296) -2.02 [1]   (NA) -0.88  (0.448) -1.33  (0.624) -0.16  (0.717)
Change at Day 399 Number Analyzed 2 participants 0 participants 0 participants 3 participants 5 participants 5 participants
0.44  (0.922) -0.61  (0.781) 0.34  (2.056) -0.11  (0.901)
Change at Day 444 Number Analyzed 1 participants 0 participants 0 participants 1 participants 2 participants 5 participants
0.47 [1]   (NA) -0.32 [1]   (NA) -0.96  (2.067) 0.11  (1.064)
Change at Day 489 Number Analyzed 1 participants 0 participants 0 participants 0 participants 2 participants 5 participants
0.68 [1]   (NA) -1.24  (0.564) 0.05  (0.769)
Change at Day 534 Number Analyzed 1 participants 0 participants 0 participants 1 participants 1 participants 5 participants
-0.10 [1]   (NA) -0.61 [1]   (NA) -1.07 [1]   (NA) -0.22  (0.685)
Change at Day 579 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 5 participants
0.16 [1]   (NA) 0.41  (0.566)
Change at Day 624 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants
0.10  (0.792)
Change at Early Discontinuation Number Analyzed 8 participants 5 participants 6 participants 4 participants 5 participants 6 participants
0.00  (0.498) 0.93  (1.106) -1.00  (0.899) -0.69  (1.087) -0.63  (0.849) -0.07  (0.948)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
16.Other Pre-specified Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 9 6 6 6 6 7
Mean (Standard Deviation)
Unit of Measure: picogram per milliliter (pg/mL)
Baseline Number Analyzed 9 participants 6 participants 6 participants 6 participants 6 participants 7 participants
12.55  (14.593) 9.11  (7.204) 17.82  (12.433) 3.96  (3.272) 11.75  (9.797) 9.49  (11.744)
Change at Day 28 Number Analyzed 9 participants 6 participants 5 participants 6 participants 6 participants 7 participants
0.45  (5.383) -2.16  (5.767) -13.12  (13.086) -2.40  (3.272) -9.70  (9.147) -7.25  (10.337)
Change at Day 56 Number Analyzed 9 participants 6 participants 5 participants 6 participants 6 participants 7 participants
-2.00  (8.081) -3.04  (6.583) -16.14  (12.643) -1.80  (3.342) -10.19  (9.797) -7.93  (11.744)
Change at Day 84 Number Analyzed 9 participants 4 participants 5 participants 6 participants 6 participants 7 participants
-0.04  (14.524) -5.60  (7.278) -14.96  (14.406) -2.08  (3.623) -10.19  (9.797) -7.29  (11.313)
Change at Day 129 Number Analyzed 8 participants 4 participants 5 participants 6 participants 6 participants 7 participants
-1.25  (8.691) -1.90  (9.291) -13.39  (13.627) -1.89  (3.907) -10.19  (9.797) -7.16  (11.507)
Change at Day 174 Number Analyzed 7 participants 2 participants 5 participants 6 participants 6 participants 7 participants
4.53  (20.905) -4.70  (14.863) -11.63  (12.903) -1.34  (4.056) -10.19  (9.797) -7.22  (11.332)
Change at Day 219 Number Analyzed 7 participants 2 participants 5 participants 6 participants 6 participants 6 participants
4.51  (19.163) -2.51  (16.794) -14.23  (13.524) -0.77  (3.830) -10.19  (9.797) -3.89  (7.796)
Change at Day 264 Number Analyzed 6 participants 1 participants 3 participants 5 participants 6 participants 5 participants
-2.33  (14.034) -17.94 [1]   (NA) -1.03  (17.395) -1.39  (2.609) -9.93  (9.856) -1.33  (1.905)
Change at Day 309 Number Analyzed 3 participants 0 participants 2 participants 5 participants 6 participants 5 participants
-1.36  (2.356) -9.19  (18.993) -1.67  (2.506) -8.87  (10.655) -1.33  (1.905)
Change at Day 354 Number Analyzed 3 participants 0 participants 1 participants 5 participants 6 participants 5 participants
-1.36  (2.356) -20.00 [1]   (NA) -2.34  (3.487) -8.61  (10.701) -1.33  (1.905)
Change at Day 399 Number Analyzed 3 participants 0 participants 0 participants 3 participants 6 participants 5 participants
-1.36  (2.356) 2.15  (4.508) -3.74  (17.157) -1.33  (1.905)
Change at Day 444 Number Analyzed 1 participants 0 participants 0 participants 1 participants 3 participants 5 participants
-4.08 [1]   (NA) 4.69 [1]   (NA) -8.19  (12.557) -0.78  (1.865)
Change at Day 489 Number Analyzed 1 participants 0 participants 0 participants 1 participants 2 participants 5 participants
-4.08 [1]   (NA) -2.51 [1]   (NA) -6.31  (19.778) -0.44  (2.157)
Change at Day 534 Number Analyzed 1 participants 0 participants 0 participants 1 participants 1 participants 5 participants
-4.08 [1]   (NA) -2.51 [1]   (NA) -20.93 [1]   (NA) -1.33  (1.905)
Change at Day 579 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 5 participants
-4.08 [1]   (NA) -1.33  (1.905)
Change at Day 624 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants
-0.85  (1.472)
[1]
Standard deviation was not estimable since only 1 participant was evaluable.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
All-Cause Mortality
Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   2/6 (33.33%)   1/6 (16.67%)   0/7 (0.00%) 
General disorders             
Chest pain * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Infections and infestations             
Abscess limb * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Pneumonia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Injury, poisoning and procedural complications             
Road traffic accident * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders             
Plantar fasciitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo PF-04236921 1 mg PF-04236921 10 mg PF-04236921 30 mg PF-04236921 100 mg PF-04236921 250 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   4/6 (66.67%)   4/6 (66.67%)   6/6 (100.00%)   6/6 (100.00%)   5/7 (71.43%) 
Blood and lymphatic system disorders             
Anaemia * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Leukopenia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  1/7 (14.29%) 
Neutropenia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Cardiac disorders             
Atrial fibrillation * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Ear and labyrinth disorders             
Tinnitus * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Eye disorders             
Conjunctivitis allergic * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Eye pain * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders             
Abdominal pain * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Abdominal pain upper * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Colonic polyp * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Constipation * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Dental caries * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Diarrhoea * 1  2/9 (22.22%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Dry mouth * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Dyspepsia * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Epigastric discomfort * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%) 
Gastritis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Gastrooesophageal reflux disease * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Nausea * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%) 
Periodontal disease * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Stomatitis * 1  0/9 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Vomiting * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
General disorders             
Asthenia * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Feeling cold * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Oedema peripheral * 1  1/9 (11.11%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Pain * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Infections and infestations             
Acute tonsillitis * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Bronchitis * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Cystitis * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/7 (0.00%) 
Folliculitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Gastroenteritis viral * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Nasopharyngitis * 1  3/9 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  2/7 (28.57%) 
Oral herpes * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Pharyngitis * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Rhinitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Sinusitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Upper respiratory tract infection * 1  1/9 (11.11%)  1/6 (16.67%)  1/6 (16.67%)  2/6 (33.33%)  1/6 (16.67%)  3/7 (42.86%) 
Urinary tract infection * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Injury, poisoning and procedural complications             
Ligament sprain * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Rib fracture * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Road traffic accident * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Traumatic haematoma * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Investigations             
Alanine aminotransferase increased * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  1/7 (14.29%) 
Aspartate aminotransferase increased * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  1/7 (14.29%) 
Blood potassium decreased * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Hepatic enzyme increased * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Urine analysis abnormal * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Weight decreased * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Dyslipidaemia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Hypercholesterolaemia * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Hypertriglyceridaemia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Hypokalaemia * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia * 1  3/9 (33.33%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  2/6 (33.33%)  0/7 (0.00%) 
Back pain * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Bursitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Intervertebral disc protrusion * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Musculoskeletal pain * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Myalgia * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Neck pain * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Osteopenia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Rheumatoid arthritis * 1  2/9 (22.22%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Gastrointestinal tract adenoma * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Lung neoplasm * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Seborrhoeic keratosis * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Thyroid neoplasm * 1  1/9 (11.11%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Nervous system disorders             
Carpal tunnel syndrome * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Dizziness * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Headache * 1  1/9 (11.11%)  0/6 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  0/6 (0.00%)  1/7 (14.29%) 
Paraesthesia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Psychiatric disorders             
Insomnia * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders             
Calculus ureteric * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Haematuria * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Nephrolithiasis * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Pyuria * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Renal cyst * 1  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Reproductive system and breast disorders             
Perineal pain * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders             
Asthma * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Cough * 1  1/9 (11.11%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Dyspnoea * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Oropharyngeal pain * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%) 
Rhinitis allergic * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders             
Alopecia * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Dermatitis * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Dermatitis contact * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Ingrowing nail * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Pruritus * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Rash * 1  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Skin ulcer * 1  0/9 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Urticaria * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Vascular disorders             
Haematoma * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Hypertension * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Orthostatic hypotension * 1  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838565    
Other Study ID Numbers: B0151002
2009-009866-15 ( EudraCT Number )
First Submitted: February 4, 2009
First Posted: February 6, 2009
Results First Submitted: August 8, 2017
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018