Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 906 for:    Lupus

Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus (BUTTERFLY)

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: NCT01405196
Recruitment Status : Completed
First Posted : July 29, 2011
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lupus Erythematosus, Systemic
Intervention Biological: PF-04236921
Enrollment 183
Recruitment Details  
Pre-assignment Details Due to safety reason, dosing in 200 mg reporting arm was prematurely terminated and the participants were discontinued from it. Therefore, the statistical analysis plan was amended after it and 200 mg reporting arm was not included in efficacy data analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Period Title: Overall Study
Started 45 47 46 45
Completed 34 35 23 36
Not Completed 11 12 23 9
Reason Not Completed
Study Terminated by Sponsor             0             0             9             0
Other             2             2             5             0
Withdrawal by Subject             4             6             3             6
Adverse Event             2             2             0             2
Death             1             0             3             0
Lost to Follow-up             2             2             3             1
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo Total
Hide Arm/Group Description Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. Total of all reporting groups
Overall Number of Baseline Participants 45 47 46 45 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 47 participants 46 participants 45 participants 183 participants
39.9  (11.48) 38.3  (10.49) 41.3  (11.29) 42.3  (13.04) 40.4  (11.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 46 participants 45 participants 183 participants
Female
43
  95.6%
44
  93.6%
43
  93.5%
38
  84.4%
168
  91.8%
Male
2
   4.4%
3
   6.4%
3
   6.5%
7
  15.6%
15
   8.2%
1.Primary Outcome
Title Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24
Hide Description SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician’s Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant’s general health status(range: 0[none] to 3[severe]).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 35 36 42
Measure Type: Number
Unit of Measure: Percentage of participants
59.9 39.2 40.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Point estimates of the Odds ratio (ORs) as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments P-value was displayed without adjusting for multiplicity.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.23
Confidence Interval (2-Sided) 90%
0.89 to 5.62
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.528
Comments P-value was displayed without adjusting for multiplicity.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.38 to 2.41
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20
Hide Description SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant’s general health status(range: 0[none] to 3[severe]).
Time Frame Week 4, 8, 12, 16, 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 43 participants 44 participants 45 participants
12.2 7.1 4.8
Week 8 Number Analyzed 43 participants 43 participants 43 participants
26.8 21.5 26.3
Week 12 Number Analyzed 39 participants 41 participants 42 participants
33.7 20 36.3
Week 16 Number Analyzed 36 participants 39 participants 41 participants
48.9 28.9 37.1
Week 20 Number Analyzed 36 participants 39 participants 43 participants
54.7 36.8 38.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.77
Confidence Interval (2-Sided) 90%
0.62 to 12.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.54
Confidence Interval (2-Sided) 90%
0.31 to 7.71
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
0.40 to 2.67
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 90%
0.29 to 2.05
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 90%
0.35 to 2.24
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.44
Confidence Interval (2-Sided) 90%
0.16 to 1.16
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.62
Confidence Interval (2-Sided) 90%
0.64 to 4.09
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.69
Confidence Interval (2-Sided) 90%
0.27 to 1.77
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.95
Confidence Interval (2-Sided) 90%
0.78 to 4.84
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
0.38 to 2.32
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24
Hide Description SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters "Low complement" and "Leukopenia"), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant’s general health status (range: 0[none] to 3[severe]).
Time Frame Week 4, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 43 participants 44 participants 45 participants
9.5 7 9.2
Week 8 Number Analyzed 43 participants 43 participants 43 participants
23.8 25.7 30.2
Week 12 Number Analyzed 39 participants 41 participants 42 participants
35.6 24.9 42.6
Week 16 Number Analyzed 36 participants 39 participants 41 participants
50.2 34 41
Week 20 Number Analyzed 36 participants 39 participants 43 participants
56.5 46.9 42.2
Week 24 Number Analyzed 35 participants 36 participants 42 participants
61.2 41.4 41.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 90%
0.28 to 3.88
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 90%
0.19 to 3.01
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.72
Confidence Interval (2-Sided) 90%
0.28 to 1.85
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.80
Confidence Interval (2-Sided) 90%
0.32 to 2.02
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.75
Confidence Interval (2-Sided) 90%
0.30 to 1.83
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.45
Confidence Interval (2-Sided) 90%
0.18 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 90%
0.58 to 3.60
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 90%
0.30 to 1.84
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.78
Confidence Interval (2-Sided) 90%
0.72 to 4.37
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 90%
0.50 to 2.92
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.22
Confidence Interval (2-Sided) 90%
0.89 to 5.55
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
0.40 to 2.46
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24
Hide Description BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant’s general health status(range: 0[none] to 3[severe]).
Time Frame Week 4, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 43 participants 44 participants 45 participants
26.2 21.7 21
Week 8 Number Analyzed 43 participants 43 participants 43 participants
26.2 29 30.6
Week 12 Number Analyzed 39 participants 41 participants 42 participants
33.6 39.6 33.3
Week 16 Number Analyzed 36 participants 39 participants 41 participants
45.5 39.2 26.2
Week 20 Number Analyzed 35 participants 39 participants 43 participants
43.7 31.6 21.7
Week 24 Number Analyzed 35 participants 36 participants 42 participants
49.7 40.5 25.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.34
Confidence Interval (2-Sided) 90%
0.53 to 3.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
0.41 to 2.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 90%
0.33 to 1.96
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 90%
0.39 to 2.23
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.42 to 2.45
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 90%
0.55 to 3.10
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.36
Confidence Interval (2-Sided) 90%
0.95 to 5.88
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.82
Confidence Interval (2-Sided) 90%
0.74 to 4.46
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.80
Confidence Interval (2-Sided) 90%
1.10 to 7.12
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.67
Confidence Interval (2-Sided) 90%
0.66 to 4.21
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.95
Confidence Interval (2-Sided) 90%
1.18 to 7.41
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.03
Confidence Interval (2-Sided) 90%
0.82 to 5.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24
Hide Description SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant’s general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 34 36 41
Measure Type: Number
Unit of Measure: Percentage of participants
4 or More Points Reduction in SLEDAI Score 60.7 44.9 49.3
No New 1A/2B BILAG 100.0 100.0 90.2
No Worsening in PhGA 97.4 97.5 93.1
Treatment Failure 0 2.8 4.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments >=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments P-value was displayed without adjusting for multiplicity.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.59
Confidence Interval (2-Sided) 90%
0.63 to 4.02
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments >=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.625
Comments P-value was displayed without adjusting for multiplicity.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 90%
0.34 to 2.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments P-value was displayed without adjusting for multiplicity.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.81
Confidence Interval (2-Sided) 90%
0.38 to 20.65
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments P-value was displayed without adjusting for multiplicity.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.88
Confidence Interval (2-Sided) 90%
0.39 to 21.30
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Tests Results
Hide Description Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL].
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants who had at least one dose of investigational product. Here, "number analyzed" signifies those participants who were evaluable at specified time points.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 46 45
Measure Type: Number
Unit of Measure: Participants
ALT Number Analyzed 45 participants 47 participants 45 participants 45 participants
2 0 0 0
Albumin: <26-20 g/L Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 1 1 1
Albumin: < 20 g/L Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 1 0 0
Amylase Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 1 1 1
AST Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 1 0 1
CK: >5.0 -10.0*ULN Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 1 1 0
CK >10.0*ULN Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 1 1 0
Glucose (Hyperglycemia) Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 1 0 2
HGB: <80 - 65 g/L Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 0 0 1
HGB: <65 g/L Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 0 0 0
Lipase Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 1 1 0
Lymph.(Abs)<0.5-0.2* 10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
6 9 4 8
Lymph.(Abs) <0.2*10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 0 0 0
Platelets <50 - 25*10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 0 0 2
Platelets <25*10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 0 0 1
Potassium (low) Number Analyzed 45 participants 47 participants 45 participants 45 participants
2 1 1 1
Sodium (low) Number Analyzed 45 participants 47 participants 45 participants 45 participants
0 0 1 0
TN (Abs)<1.0-0.5*10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
4 5 3 2
TN (Abs) <0.5*10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 1 1 0
Triglycerides Number Analyzed 44 participants 47 participants 45 participants 45 participants
0 1 0 2
WBC <2.0 - 1.0*10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
4 2 2 2
WBC <1.0*10^3/UL Number Analyzed 45 participants 47 participants 45 participants 45 participants
1 0 0 0
7.Secondary Outcome
Title Number of Participants Who Discontinued Due to Adverse Events
Hide Description An AE was any untoward medical occurrence in a participant who received study drug 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. Number of participants who discontinued due to adverse events were reported.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants who had at least one dose of investigational product.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 46 45
Measure Type: Number
Unit of Measure: Participants
3 2 3 3
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug 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 drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants who had at least one dose of investigational product.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 46 45
Measure Type: Number
Unit of Measure: Participants
AEs 34 36 38 40
SAEs 4 2 7 8
9.Secondary Outcome
Title Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug 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 drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants who had at least one dose of investigational product.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 46 45
Measure Type: Number
Unit of Measure: Participants
Infectious AEs 25 28 25 26
Infectious SAEs 2 3 4 4
10.Secondary Outcome
Title Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings
Hide Description Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants who had at least one dose of investigational product. Here, N (Number of participants analyzed) signifies participants evaluable for this outcome measure for each group respectively.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 42 46 44 44
Measure Type: Number
Unit of Measure: Participants
Heart Rate <=40 beats/min or >=120 beats/min 0 0 0 0
PR Interval >=200 msec 2 1 1 2
QT Interval >=480 msec 2 0 0 0
QRS Interval >=120 msec 3 1 2 2
QTcF >=500 msec 2 0 0 0
Rhythm (Not Sinus Rhythm) 0 0 0 1
11.Secondary Outcome
Title Number of Participants With Potentially Clinically Important Vital Signs Findings
Hide Description Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight)
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants who had at least one dose of investigational product.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 46 45
Measure Type: Number
Unit of Measure: Participants
Sitting Systolic Blood Pressure 8 3 3 5
Sitting Diastolic Blood Pressure 14 14 12 14
Sitting Pulse Rate 1 1 0 1
Temperature 0 0 0 0
Weight 12 23 14 14
12.Secondary Outcome
Title Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)
Hide Description Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay.
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population defined as all participants who had at least one dose of investigational product.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 46 45
Measure Type: Number
Unit of Measure: Participants
Anti-drug Antibodies 1 0 1 0
Neutralizing Antibodies 0 0 0 0
13.Secondary Outcome
Title Serum Concentration of PF-04236921
Hide Description Serum PF-04236921 concentrations over time were summarized.
Time Frame Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set was the subset of participants from safety analysis set (all participants who received at least 1 dose of investigational product) who provided at least 1 pharmacokinetic concentration. Here, "number analyzed" signifies those participants who were evaluable at specified time points.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg PF-04236921 200 mg
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 46
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Day 1 Number Analyzed 42 participants 45 participants 43 participants
26.3  (110.8) 31.0  (146.9) 15.2  (99.8)
Week 2 Number Analyzed 37 participants 41 participants 40 participants
1297  (759.4) 5640  (2274.0) 22780  (9896.0)
Week 4 Number Analyzed 39 participants 42 participants 38 participants
991.8  (527.6) 4337  (1495.0) 17550  (5757.1)
Week 6 Number Analyzed 39 participants 40 participants 37 participants
608.4  (330.1) 3396  (1410.0) 13460  (5416.6)
Week 8 Number Analyzed 39 participants 38 participants 30 participants
463.4  (254.9) 2709  (1317.5) 11110  (5023.7)
Week 12 Number Analyzed 32 participants 33 participants 28 participants
1210  (607.0) 6482  (2487.4) 25240  (8114.0)
Week 16 Number Analyzed 31 participants 36 participants 23 participants
703.2  (407.4) 3886  (1322.1) 16990  (6203.4)
Week 20 Number Analyzed 30 participants 34 participants 17 participants
1452  (726.8) 6978  (2954.0) 31050  (11368)
Week 24 Number Analyzed 31 participants 34 participants 18 participants
871.9  (450.4) 4417  (2402.4) 20150  (12091)
14.Secondary Outcome
Title Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)
Hide Description Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant’s symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data.
Time Frame Week 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoints. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 15 24 23
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 12 13.3 20.8 8.7
Week 16 20.0 25.0 8.7
Week 20 26.7 25.0 8.7
Week 24 26.7 20.8 8.7
15.Secondary Outcome
Title Percentage of Participants With Normalized Serological Activity
Hide Description Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.
Time Frame Baseline up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Consistent with the protocol which pre-specified that if the number of participants with abnormal serological activity at baseline were <25% of overall population, data for this outcome measure was not available.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Patient Global Visual Analog Scale (VAS) Scores at Baseline
Hide Description Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question “Considering all the ways your disease affects you, how are you feeling today?” Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Mean (Standard Error)
Unit of Measure: mm
50.44  (2.865) 47.70  (2.880) 49.47  (3.349)
17.Secondary Outcome
Title Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24
Hide Description Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question “Considering all the ways your disease affects you, how are you feeling today?” Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad).
Time Frame Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
Week 2 Number Analyzed 44 participants 47 participants 43 participants
-9.17
(-15.09 to -3.26)
-1.54
(-7.22 to 4.15)
-3.58
(-9.49 to 2.34)
Week 4 Number Analyzed 45 participants 47 participants 45 participants
-3.24
(-9.09 to 2.62)
-4.01
(-9.69 to 1.68)
-1.24
(-7.02 to 4.55)
Week 6 Number Analyzed 45 participants 47 participants 45 participants
-5.48
(-11.33 to 0.37)
-3.62
(-9.31 to 2.06)
-7.24
(-13.02 to -1.45)
Week 8 Number Analyzed 45 participants 47 participants 45 participants
-4.17
(-10.02 to 1.68)
-6.03
(-11.71 to -0.34)
-7.11
(-12.89 to -1.32)
Week 12 Number Analyzed 45 participants 47 participants 45 participants
-9.21
(-15.07 to -3.36)
-4.20
(-9.88 to 1.49)
-6.88
(-12.67 to -1.10)
Week 16 Number Analyzed 45 participants 47 participants 45 participants
-8.75
(-14.60 to -2.89)
-10.20
(-15.88 to -4.51)
-5.99
(-11.78 to -0.21)
Week 20 Number Analyzed 45 participants 47 participants 45 participants
-11.52
(-17.38 to -5.67)
-9.03
(-14.71 to -3.34)
-6.77
(-12.56 to -0.99)
Week 24 Number Analyzed 45 participants 47 participants 45 participants
-9.17
(-15.02 to -3.32)
-7.45
(-13.14 to -1.77)
-10.64
(-16.42 to -4.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.41
Confidence Interval (2-Sided) 90%
-12.30 to 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.39
Confidence Interval (2-Sided) 90%
-8.21 to 5.42
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 1.30
Confidence Interval (2-Sided) 90%
-5.71 to 8.32
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 4.67
Confidence Interval (2-Sided) 90%
-2.22 to 11.57
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -3.98
Confidence Interval (2-Sided) 90%
-11.04 to 3.07
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.89
Confidence Interval (2-Sided) 90%
-9.87 to 4.10
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -6.21
Confidence Interval (2-Sided) 90%
-13.37 to 0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 1.98
Confidence Interval (2-Sided) 90%
-5.17 to 9.13
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 2.07
Confidence Interval (2-Sided) 90%
-4.70 to 8.84
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.81
Confidence Interval (2-Sided) 90%
-9.62 to 4.00
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 3.97
Confidence Interval (2-Sided) 90%
-2.95 to 10.90
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 2.56
Confidence Interval (2-Sided) 90%
-4.29 to 9.40
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 3.14
Confidence Interval (2-Sided) 90%
-3.67 to 9.94
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -4.94
Confidence Interval (2-Sided) 90%
-11.91 to 2.03
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.64
Confidence Interval (2-Sided) 90%
-9.61 to 4.32
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value 2.66
Confidence Interval (2-Sided) 90%
-4.48 to 9.80
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24
Hide Description EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state).
Time Frame Baseline, Week 4, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 4 Number Analyzed 43 participants 46 participants 45 participants
3.17
(-2.21 to 8.54)
1.45
(-3.72 to 6.62)
-0.47
(-5.66 to 4.73)
Week 8 Number Analyzed 43 participants 47 participants 45 participants
5.00
(-0.37 to 10.38)
2.82
(-2.28 to 7.93)
7.02
(1.83 to 12.22)
Week 12 Number Analyzed 43 participants 47 participants 45 participants
7.47
(2.09 to 12.85)
2.51
(-2.60 to 7.61)
4.85
(-0.35 to 10.04)
Week 16 Number Analyzed 43 participants 47 participants 45 participants
6.84
(1.47 to 12.22)
6.65
(1.55 to 11.76)
5.16
(-0.04 to 10.35)
Week 20 Number Analyzed 43 participants 47 participants 45 participants
9.68
(4.30 to 15.05)
5.19
(0.08 to 10.29)
5.09
(-0.10 to 10.28)
Week 24 Number Analyzed 43 participants 47 participants 45 participants
9.33
(3.95 to 14.71)
5.04
(-0.07 to 10.14)
5.38
(0.18 to 10.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.63
Confidence Interval 90%
-2.56 to 9.83
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.02
Confidence Interval 90%
-8.21 to 4.18
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.62
Confidence Interval (2-Sided) 90%
-3.57 to 8.82
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.69
Confidence Interval (2-Sided) 90%
-4.51 to 7.88
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.59
Confidence Interval (2-Sided) 90%
-1.61 to 10.79
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.95
Confidence Interval 90%
-2.24 to 10.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.92
Confidence Interval 90%
-4.17 to 8.01
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.20
Confidence Interval 90%
-10.25 to 1.85
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.50
Confidence Interval (2-Sided) 90%
-4.56 to 7.55
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.10
Confidence Interval (2-Sided) 90%
-5.96 to 6.15
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.34
Confidence Interval (2-Sided) 90%
-6.39 to 5.71
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -2.34
Confidence Interval (2-Sided) 90%
-8.39 to 3.71
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoint. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 43 46 45
Mean (Standard Error)
Unit of Measure: Units on a scale
MCS 39.50  (1.810) 42.36  (1.426) 39.94  (1.450)
PCS 33.47  (1.169) 34.36  (1.250) 34.64  (1.523)
20.Secondary Outcome
Title Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame Baseline, Week 4, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
MCS: Week 4 Number Analyzed 43 participants 45 participants 45 participants
1.97
(-0.69 to 4.64)
1.45
(-1.14 to 4.04)
1.45
(-1.12 to 4.02)
MCS: Week 8 Number Analyzed 43 participants 46 participants 45 participants
1.57
(-1.10 to 4.23)
1.97
(-0.59 to 4.52)
2.05
(-0.52 to 4.62)
MCS: Week 12 Number Analyzed 43 participants 46 participants 45 participants
3.80
(1.13 to 6.46)
2.50
(-0.06 to 5.05)
2.52
(-0.05 to 5.09)
MCS: Week 16 Number Analyzed 43 participants 46 participants 45 participants
4.73
(2.07 to 7.40)
2.79
(0.24 to 5.35)
2.95
(0.38 to 5.52)
MCS: Week 20 Number Analyzed 43 participants 46 participants 45 participants
4.49
(1.82 to 7.15)
1.71
(-0.85 to 4.26)
3.28
(0.71 to 5.85)
MCS: Week 24 Number Analyzed 43 participants 46 participants 45 participants
2.94
(0.28 to 5.60)
2.14
(-0.41 to 4.70)
2.85
(0.28 to 5.42)
PCS: Week 4 Number Analyzed 43 participants 45 participants 45 participants
3.95
(1.75 to 6.15)
3.24
(1.10 to 5.38)
1.28
(-0.85 to 3.40)
PCS: Week 8 Number Analyzed 43 participants 46 participants 45 participants
5.48
(3.27 to 7.68)
4.79
(2.68 to 6.90)
2.11
(-0.01 to 4.23)
PCS: Week 12 Number Analyzed 43 participants 46 participants 45 participants
6.06
(3.86 to 8.26)
4.66
(2.55 to 6.77)
2.82
(0.70 to 4.95)
PCS: Week 16 Number Analyzed 43 participants 46 participants 45 participants
6.25
(4.05 to 8.45)
4.50
(2.39 to 6.61)
2.48
(0.36 to 4.60)
PCS: Week 20 Number Analyzed 43 participants 46 participants 45 participants
6.39
(4.19 to 8.59)
5.63
(3.52 to 7.74)
3.29
(1.17 to 5.42)
PCS: Week 24 Number Analyzed 43 participants 46 participants 45 participants
5.98
(3.77 to 8.18)
5.53
(3.42 to 7.64)
2.94
(0.82 to 5.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.53
Confidence Interval (2-Sided) 90%
-2.53 to 3.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.48
Confidence Interval (2-Sided) 90%
-3.54 to 2.58
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.28
Confidence Interval (2-Sided) 90%
-1.78 to 4.34
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.78
Confidence Interval (2-Sided) 90%
-1.28 to 4.84
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.20
Confidence Interval (2-Sided) 90%
-1.86 to 4.26
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-2.98 to 3.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-3.03 to 3.03
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.09
Confidence Interval (2-Sided) 90%
-3.09 to 2.92
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 90%
-3.03 to 2.99
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.16
Confidence Interval (2-Sided) 90%
-3.17 to 2.85
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.58
Confidence Interval (2-Sided) 90%
-4.58 to 1.43
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.71
Confidence Interval (2-Sided) 90%
-3.72 to 2.30
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.67
Confidence Interval (2-Sided) 90%
0.14 to 5.20
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.36
Confidence Interval (2-Sided) 90%
0.84 to 5.89
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.23
Confidence Interval (2-Sided) 90%
0.70 to 5.76
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.77
Confidence Interval (2-Sided) 90%
1.24 to 6.30
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.10
Confidence Interval (2-Sided) 90%
0.57 to 5.63
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.03
Confidence Interval 90%
0.50 to 5.56
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.96
Confidence Interval (2-Sided) 90%
-0.53 to 4.46
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.68
Confidence Interval 90%
0.20 to 5.17
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.84
Confidence Interval (2-Sided) 90%
-0.65 to 4.32
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.01
Confidence Interval (2-Sided) 90%
-0.47 to 4.50
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.34
Confidence Interval (2-Sided) 90%
-0.15 to 4.82
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.59
Confidence Interval (2-Sided) 90%
0.11 to 5.08
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24
Hide Description SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame Baseline, Week 4, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Week 4 Number Analyzed 43 participants 45 participants 45 participants
3.92
(-2.00 to 9.83)
4.78
(-0.97 to 10.52)
3.45
(-2.27 to 9.16)
Week 8 Number Analyzed 43 participants 46 participants 45 participants
6.53
(0.62 to 12.45)
6.55
(0.87 to 12.23)
2.61
(-3.10 to 8.33)
Week 12 Number Analyzed 43 participants 46 participants 45 participants
10.75
(4.83 to 16.66)
6.41
(0.74 to 12.09)
7.19
(1.48 to 12.91)
Week 16 Number Analyzed 43 participants 46 participants 45 participants
10.60
(4.69 to 16.52)
6.41
(0.74 to 12.09)
2.75
(-2.97 to 8.46)
Week 20 Number Analyzed 43 participants 46 participants 45 participants
11.91
(5.99 to 17.82)
7.78
(2.10 to 13.45)
4.79
(-0.93 to 10.50)
Week 24 Number Analyzed 43 participants 46 participants 45 participants
9.58
(3.66 to 15.49)
6.69
(1.01 to 12.37)
5.25
(-0.47 to 10.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.47
Confidence Interval 90%
-6.33 to 7.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.92
Confidence Interval 90%
-2.88 to 10.72
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.55
Confidence Interval (2-Sided) 90%
-3.25 to 10.36
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.85
Confidence Interval (2-Sided) 90%
1.05 to 14.66
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.12
Confidence Interval (2-Sided) 90%
0.32 to 13.92
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.33
Confidence Interval (2-Sided) 90%
-2.47 to 11.13
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.33
Confidence Interval (2-Sided) 90%
-5.40 to 8.05
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.93
Confidence Interval (2-Sided) 90%
-2.75 to 10.62
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.78
Confidence Interval (2-Sided) 90%
-7.47 to 5.91
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.67
Confidence Interval 90%
-3.02 to 10.35
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.99
Confidence Interval (2-Sided) 90%
-3.70 to 9.68
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection PF-04236921 50 mg, Placebo
Comments Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.44
Confidence Interval (2-Sided) 90%
-5.24 to 8.13
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24
Hide Description The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.
Time Frame Baseline, Week 4, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.
Arm/Group Title PF-04236921 10 Milligram (10 mg) PF-04236921 50 mg Placebo
Hide Arm/Group Description:
Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
Overall Number of Participants Analyzed 45 47 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
MCS: Week 4 Number Analyzed 43 participants 45 participants 45 participants
1.97
(-0.69 to 4.64)
1.45
(-1.14 to 4.04)
1.45
(-1.12 to 4.02)
MCS: Week 8 Number Analyzed 43 participants 46 participants 45 participants
1.57
(-1.10 to 4.23)
1.97
(-0.59 to 4.52)
2.05
(-0.52 to 4.62)
MCS: Week 12 Number Analyzed 43 participants 46 participants 45 participants
3.80
(1.13 to 6.46)
2.50
(-0.06 to 5.05)
2.52
(-0.05 to 5.09)
MCS: Week 16 Number Analyzed 43 participants 46 participants 45 participants
4.73
(2.07 to 7.40)
2.79
(0.24 to 5.35)
2.95
(0.38 to 5.52)
MCS: Week 20 Number Analyzed 43 participants 46 participants 45 participants
4.49
(1.82 to 7.15)
1.71
(-0.85 to 4.26)
3.28
(0.71 to 5.85)
MCS: Week 24 Number Analyzed 43 participants 46 participants 45 participants
2.94
(0.28 to 5.60)
2.14
(-0.41 to 4.70)
2.85
(0.28 to 5.42)
PCS: Week 4 Number Analyzed 43 participants 45 participants 45 participants
3.95
(1.75 to 6.15)
3.24
(1.10 to 5.38)
1.28
(-0.85 to 3.40)
PCS: Week 8 Number Analyzed 43 participants 46 participants 45 participants
5.48
(3.27 to 7.68)
4.79
(2.68 to 6.90)
2.11
(-0.01 to 4.23)
PCS: Week 12 Number Analyzed 43 participants 46 participants 45 participants
6.06
(3.86 to 8.26)
4.66
(2.55 to 6.77)
2.82
(0.70 to 4.95)
PCS: Week 16 Number Analyzed 43 participants 46 participants 45 participants
6.25
(4.05 to 8.45)
4.50
(2.39 to 6.61)
2.48
(0.36 to 4.60)
PCS: Week 20 Number Analyzed 43 participants 46 participants 45 participants
6.39
(4.19 to 8.59)
5.63
(3.52 to 7.74)
3.29
(1.17 to 5.42)
PCS: Week 24 Number Analyzed 43 participants 46 participants 45 participants
5.98
(3.77 to 8.18)
5.53
(3.42 to 7.64)
2.94
(0.82 to 5.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.53
Confidence Interval (2-Sided) 90%
-2.53 to 3.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.48
Confidence Interval (2-Sided) 90%
-3.54 to 2.58
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.28
Confidence Interval (2-Sided) 90%
-1.78 to 4.34
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.78
Confidence Interval (2-Sided) 90%
-1.28 to 4.84
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.20
Confidence Interval (2-Sided) 90%
-1.86 to 4.26
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04236921 10 Milligram (10 mg), Placebo
Comments MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 90%
-2.98 to 3.15
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7