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Trial record 3 of 5 for:    PF-06410293

A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230213
Recruitment Status : Completed
First Posted : January 18, 2020
Results First Posted : August 22, 2022
Last Update Posted : August 22, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: PF-06410293
Drug: adalimumab
Enrollment 455
Recruitment Details  
Pre-assignment Details A total of 455 participants were enrolled in the study of which 10 participants were excluded from all the data analyses due to violation of Good Clinical Practice (GCP) principles. These 10 participants were not included in any section of results.
Arm/Group Title Humira (Adalimumab) Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description All participants received Humira 40 milligrams (mg) once every 2 weeks subcutaneously for 10 weeks during Treatment Period 1 (TP1). Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose. Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Period Title: TP1: Week 0 (Day 1) to Week 10
Started 445 0 0
Completed 427 0 0
Not Completed 18 0 0
Reason Not Completed
Other             8             0             0
Withdrawal by Subject             7             0             0
Physician Decision             3             0             0
Period Title: TP2: Week 10 to Week 16
Started 0 [1] 213 [2] 214 [3]
Completed 0 211 211
Not Completed 0 2 3
Reason Not Completed
Other             0             2             1
Withdrawal by Subject             0             0             2
[1]
TP1 ended when participants were randomized to Switching and Non-switching Arms
[2]
Participants who completed TP1 were randomized to Switching arm.
[3]
Participants who completed TP1 were randomized to Non-switching arm.
Period Title: TP3: Week 16 to Week 22
Started 0 211 211
Completed 0 210 204
Not Completed 0 1 7
Reason Not Completed
Lost to Follow-up             0             0             1
Withdrawal by Subject             0             0             2
Physician Decision             0             0             1
Other             0             1             3
Period Title: TP4: Week 22 to Week 32
Started 0 210 204
Completed 0 202 196
Not Completed 0 8 8
Reason Not Completed
Other             0             5             5
Withdrawal by Subject             0             1             2
Physician Decision             0             2             1
Period Title: Follow up: Week 32 to Week 36
Started 0 202 196
Completed 0 201 194
Not Completed 0 1 2
Reason Not Completed
Withdrawal by Subject             0             0             1
Other             0             1             1
Arm/Group Title Humira (Adalimumab)
Hide Arm/Group Description All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1. After completing TP1, participants were randomized to Switching Arm: Humira and PF-06410293 (Adalimumab) and Non-switching Arm: Humira (Adalimumab). Participants randomized to Switching Arm: Humira and PF-06410293 (Adalimumab) received PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during TP2. TP2 was followed by TP3. In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by TP4. In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants randomized to Non-switching Arm: Humira (Adalimumab) after completing TP1 continued treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Baseline Participants 445
Hide Baseline Analysis Population Description
Baseline analysis population included all the participants who were enrolled in TP1.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Lead-In TP1: Humira (Adalimumab) Number Analyzed 445 participants
53.60  (11.17)
Switching arm: Humira and PF-06410293 (Adalimumab) Number Analyzed 213 participants
53.60  (11.26)
Non-Switching arm: Humira (Adalimumab) Number Analyzed 214 participants
53.35  (11.30)
[1]
Measure Analysis Population Description: Here, number analyzed signifies number of participants evaluable for specified rows i.e. Humira (adalimumab) arm including all participants enrolled in TP1 and Switching arm: Humira and PF-06410293 (Adalimumab) and Non-switching Arm: Humira (Adalimumab) arms including all participants who were randomized at Week 10.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Lead-In TP1: Humira (Adalimumab) Number Analyzed 445 participants
Female
368
  82.7%
Male
77
  17.3%
Switching arm: Humira and PF-06410293 (Adalimumab) Number Analyzed 213 participants
Female
175
  82.2%
Male
38
  17.8%
Non-Switching arm: Humira (Adalimumab) Number Analyzed 214 participants
Female
179
  83.6%
Male
35
  16.4%
[1]
Measure Analysis Population Description: Here, number analyzed signifies number of participants evaluable for specified rows i.e. Humira (adalimumab) arm including all participants enrolled in TP1 and Switching arm: Humira and PF-06410293 (Adalimumab) and Non-switching Arm: Humira (Adalimumab) arms including all participants who were randomized at Week 10.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Lead-In TP1: Humira (Adalimumab) Number Analyzed 445 participants
Hispanic or Latino
4
   0.9%
Not Hispanic or Latino
440
  98.9%
Unknown or Not Reported
1
   0.2%
Switching arm: Humira and PF-06410293 (Adalimumab) Number Analyzed 213 participants
Hispanic or Latino
2
   0.9%
Not Hispanic or Latino
210
  98.6%
Unknown or Not Reported
1
   0.5%
Non-Switching arm: Humira (Adalimumab) Number Analyzed 214 participants
Hispanic or Latino
1
   0.5%
Not Hispanic or Latino
213
  99.5%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: Here, number analyzed signifies number of participants evaluable for specified rows i.e. Humira (adalimumab) arm including all participants enrolled in TP1 and Switching arm: Humira and PF-06410293 (Adalimumab) and Non-switching Arm: Humira (Adalimumab) arms including all participants who were randomized at Week 10.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Lead-In TP1: Humira (Adalimumab) Number Analyzed 445 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   0.4%
White
440
  98.9%
More than one race
0
   0.0%
Unknown or Not Reported
3
   0.7%
Switching arm: Humira and PF-06410293 (Adalimumab) Number Analyzed 213 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
212
  99.5%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.5%
Non-Switching arm: Humira (Adalimumab) Number Analyzed 214 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
210
  98.1%
More than one race
2
   0.9%
Unknown or Not Reported
2
   0.9%
[1]
Measure Analysis Population Description: Here, number analyzed signifies number of participants evaluable for specified rows i.e. Humira (adalimumab) arm including all participants enrolled in TP1 and Switching arm: Humira and PF-06410293 (Adalimumab) and Non-switching Arm: Humira (Adalimumab) arms including all participants who were randomized at Week 10.
1.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Adalimumab
Hide Description Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.
Time Frame Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all randomized participants who were dosed to initiate the week 30 steady-state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 194 186
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
9.156
(97%)
8.974
(97%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switching Arm: Humira and PF-06410293 (Adalimumab), Non-switching Arm: Humira (Adalimumab)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.
Method of Estimation Estimation Parameter Geometric mean ratio (percentage)
Estimated Value 102.56
Confidence Interval (2-Sided) 90%
89.78 to 117.17
Estimation Comments Analysis was performed using analysis of variance (ANOVA) model.
2.Primary Outcome
Title Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab
Hide Description Area under the serum concentration curve from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. The geometric coefficient of variation is expressed in percentage.
Time Frame Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all randomized participants who were dosed to initiate the Week 30 steady-state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 189 183
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter*hour
2.472
(129%)
2.365
(133%)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switching Arm: Humira and PF-06410293 (Adalimumab), Non-switching Arm: Humira (Adalimumab)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.
Method of Estimation Estimation Parameter Geometric mean ratio (Percentage)
Estimated Value 105.31
Confidence Interval (2-Sided) 90%
89.16 to 124.39
Estimation Comments Analysis was performed using ANOVA model.
3.Secondary Outcome
Title Time to Reach Cmax (Tmax) of Adalimumab
Hide Description Tmax is the time taken (in hours) to reach the maximum serum drug concentration.
Time Frame Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all randomized participants who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 194 186
Median (Full Range)
Unit of Measure: Hours
71.80
(0.000 to 336)
72.00
(0.000 to 337)
4.Secondary Outcome
Title Average Serum Concentration (Cav) of Adalimumab
Hide Description Cav was defined as average serum concentration over the dosing interval. The geometric coefficient of variation is expressed in percentage.
Time Frame Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all randomized participants who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 189 183
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
7.357
(130%)
7.040
(133%)
5.Secondary Outcome
Title Apparent Clearance (CL/F) of Serum Adalimumab
Hide Description Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf). The geometric coefficient of variation is expressed in percentage.
Time Frame Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population included all randomized participants who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 189 183
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Milliliter per hour
16.19
(129%)
16.91
(133%)
6.Secondary Outcome
Title Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab
Hide Description Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.
Time Frame Pre-dose on Day 1, 71,113, 155, 169, 183, 197 and 211
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Data for Days 1 and 71 were identified retrospectively for participants in the safety randomized population, hence included in the switching and non-switching reporting groups. Here, "Number Analyzed" signifies participants evaluable for each specified category.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Mean (Standard Deviation)
Unit of Measure: Micrograms per milliliter
Day 1 Number Analyzed 213 participants 214 participants
0.03102  (0.15291) 0.05703  (0.29719)
Day 71 Number Analyzed 211 participants 214 participants
6.999  (4.4196) 6.675  (4.3310)
Day 113 Number Analyzed 210 participants 209 participants
7.763  (5.0812) 7.374  (4.8807)
Day 155 Number Analyzed 208 participants 200 participants
7.900  (5.2493) 7.558  (5.0502)
Day 169 Number Analyzed 204 participants 197 participants
7.918  (5.1756) 7.767  (5.1860)
Day 183 Number Analyzed 202 participants 197 participants
8.259  (5.3404) 7.933  (5.1299)
Day 197 Number Analyzed 204 participants 197 participants
8.347  (5.5458) 8.022  (5.2046)
Day 211 Number Analyzed 206 participants 198 participants
8.477  (5.4604) 7.891  (5.1818)
7.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomization in TP2. AEs included both serious and all non-serious AEs.
Time Frame Day 1 up to maximum of 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.
Arm/Group Title Humira (Adalimumab)
Hide Arm/Group Description:
All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Overall Number of Participants Analyzed 445
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
107
  24.0%
Serious TEAEs
13
   2.9%
Treatment related TEAEs
31
   7.0%
8.Secondary Outcome
Title Number of Participants With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE for TP2 and beyond was defined as any AE that occurred after administering the first dose of study treatment after randomization in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs.
Time Frame Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
82
  38.5%
62
  29.0%
Serious TEAEs
3
   1.4%
8
   3.7%
Treatment related TEAEs
19
   8.9%
10
   4.7%
9.Secondary Outcome
Title Number of Participants With Grade 3 or Higher TEAEs: TP1
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomization in TP2. AEs were graded using the Common Terminology Criteria for Adverse Events where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening consequences; urgent intervention indicated; and grade 5= death related to AE. Number of participants with grade 3 or higher TEAEs were presented.
Time Frame Day 1 up to maximum of 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.
Arm/Group Title Humira (Adalimumab)
Hide Arm/Group Description:
All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Overall Number of Participants Analyzed 445
Measure Type: Count of Participants
Unit of Measure: Participants
14
   3.1%
10.Secondary Outcome
Title Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomization in TP2 and up to 4 weeks after last dose. AEs were graded using the Common Terminology Criteria for Adverse Events where, grade 1=mild AE; grade 2=moderate AE; grade 3=severe AE; grade 4= life-threatening consequences; urgent intervention indicated; and grade 5= death related to AE. Number of participants with grade 3 or higher TEAEs were presented.
Time Frame Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Measure Type: Count of Participants
Unit of Measure: Participants
5
   2.3%
8
   3.7%
11.Secondary Outcome
Title Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP1
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomization in TP2. Participants who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Participants who discontinued from study due to TEAE were those who had an TEAE in TP1 indicating that the AE caused the participant to be discontinued from the study.
Time Frame Day 1 up to maximum of 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.
Arm/Group Title Humira (Adalimumab)
Hide Arm/Group Description:
All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Overall Number of Participants Analyzed 445
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued from treatment due to TEAEs
3
   0.7%
Discontinued from study due to TEAE
12
   2.7%
12.Secondary Outcome
Title Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP2 and Beyond
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomization in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs. Participants who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Participants who discontinued from study due to TEAE were those who had an AE record indicating that the AE caused the participant to be discontinued from the study.
Time Frame Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued from treatment due to TEAEs
0
   0.0%
3
   1.4%
Discontinued from study due to TEAEs
8
   3.8%
9
   4.2%
13.Secondary Outcome
Title Number of Participants With TEAEs of Special Interest: TP2 and Beyond
Hide Description AEs of special interest (AESI) included: hypersensitivity events (anaphylactic reaction, hypersensitivity, angioedema, delayed immune responses and injection site reactions [ISRs]); blood and lymphatic system events (white blood cell disorders and anemias nonhemolytic and marrow depression); cardiovascular events (cardiac failure, hypertension and myocardial infarction); demyelinating conditions, gastric/hepatic events (gastrointestinal perforation, ulceration, hemorrhage or obstruction and hepatic disorders); infections and infestations (including TB and other opportunistic infections); malignancies (neoplasms benign, malignant and unspecified [including cysts and polyps]) and lupus like syndrome. TEAE was defined as any AE that occurred after the first dose of study treatment administered after randomization in TP2. Number of participants with any AESI were presented in this outcome measure.
Time Frame Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Measure Type: Count of Participants
Unit of Measure: Participants
58
  27.2%
47
  22.0%
14.Secondary Outcome
Title Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1
Hide Description In this outcome, participants who were antidrug antibody (ADA) positive during TP1 were assessed in TP2 and beyond per visit for their ADA status at the time of start of their potential immunogenic AEs including ISRs, medically evaluated board standard MedDRA query (SMQ) of potential hypersensitivity (anaphylactic reactions, hypersensitivity and angioedema), medically evaluated AEs meeting Sampson criteria, cytokine storm and delayed immune responses (DIR). ADA positive was defined as ADA titer >=1.88.
Time Frame TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10.Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specific rows.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 55 59
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16: ISR Number Analyzed 55 participants 57 participants
0
   0.0%
1
   1.8%
Week 16: Medically evaluated Sampson criteria met Number Analyzed 55 participants 57 participants
0
   0.0%
0
   0.0%
Week 16: AEs belonging to SMQ Group Number Analyzed 55 participants 57 participants
0
   0.0%
0
   0.0%
Week 22: ISR Number Analyzed 55 participants 55 participants
0
   0.0%
1
   1.8%
Week 22: Medically evaluated Sampson criteria met Number Analyzed 55 participants 55 participants
0
   0.0%
0
   0.0%
Week 22: AEs belonging to SMQ Group Number Analyzed 55 participants 55 participants
0
   0.0%
0
   0.0%
Week 24: ISR Number Analyzed 55 participants 54 participants
0
   0.0%
1
   1.9%
Week 24: Medically evaluated Sampson criteria met Number Analyzed 55 participants 54 participants
0
   0.0%
0
   0.0%
Week 24: AEs belonging to SMQ Group Number Analyzed 55 participants 54 participants
0
   0.0%
1
   1.9%
Week 26: ISR Number Analyzed 54 participants 53 participants
1
   1.9%
1
   1.9%
Week 26: Medically evaluated Sampson criteria met Number Analyzed 54 participants 53 participants
0
   0.0%
0
   0.0%
Week 26: AEs belonging to SMQ Group Number Analyzed 54 participants 53 participants
0
   0.0%
0
   0.0%
Week 28: ISR Number Analyzed 55 participants 53 participants
0
   0.0%
1
   1.9%
Week 28: Medically evaluated Sampson criteria met Number Analyzed 55 participants 53 participants
0
   0.0%
0
   0.0%
Week 28: AEs belonging to SMQ Group Number Analyzed 55 participants 53 participants
0
   0.0%
0
   0.0%
Week 30: ISR Number Analyzed 55 participants 54 participants
0
   0.0%
1
   1.9%
Week 30: Medically evaluated Sampson criteria met Number Analyzed 55 participants 54 participants
0
   0.0%
0
   0.0%
Week 30: AEs belonging to SMQ Group Number Analyzed 55 participants 54 participants
1
   1.8%
0
   0.0%
Week 32: ISR Number Analyzed 54 participants 59 participants
0
   0.0%
0
   0.0%
Week 32: Medically evaluated Sampson criteria met Number Analyzed 54 participants 59 participants
0
   0.0%
0
   0.0%
Week 32: AEs belonging to SMQ Group Number Analyzed 54 participants 59 participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1
Hide Description In this outcome, participants who were ADA negative during TP1 were assessed in TP2 and beyond per visit for their ADA status at the time of start of their potential immunogenic AEs including ISRs, medically evaluated board SMQ of potential hypersensitivity (anaphylactic reactions, hypersensitivity and angioedema), medically evaluated AEs meeting Sampson criteria, cytokine storm and DIR. ADA negative was defined as ADA titer <1.88.
Time Frame TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10.Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specific rows.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 156 155
Measure Type: Count of Participants
Unit of Measure: Participants
Week 16: ISR Number Analyzed 153 participants 152 participants
4
   2.6%
2
   1.3%
Week 16: Medically evaluated Sampson criteria met Number Analyzed 153 participants 152 participants
0
   0.0%
0
   0.0%
Week 16: AEs belonging to SMQ Group Number Analyzed 153 participants 152 participants
0
   0.0%
0
   0.0%
Week 22: ISR Number Analyzed 151 participants 147 participants
1
   0.7%
1
   0.7%
Week 22: Medically evaluated Sampson criteria met Number Analyzed 151 participants 147 participants
0
   0.0%
0
   0.0%
Week 22: AEs belonging to SMQ Group Number Analyzed 151 participants 147 participants
0
   0.0%
0
   0.0%
Week 24: ISR Number Analyzed 150 participants 145 participants
0
   0.0%
2
   1.4%
Week 24: Medically evaluated Sampson criteria met Number Analyzed 150 participants 145 participants
0
   0.0%
0
   0.0%
Week 24: AEs belonging to SMQ Group Number Analyzed 150 participants 145 participants
0
   0.0%
0
   0.0%
Week 26: ISR Number Analyzed 148 participants 145 participants
0
   0.0%
2
   1.4%
Week 26: Medically evaluated Sampson criteria met Number Analyzed 148 participants 145 participants
0
   0.0%
0
   0.0%
Week 26: AEs belonging to SMQ Group Number Analyzed 148 participants 145 participants
0
   0.0%
0
   0.0%
Week 28: ISR Number Analyzed 148 participants 144 participants
0
   0.0%
1
   0.7%
Week 28: Medically evaluated Sampson criteria met Number Analyzed 148 participants 144 participants
0
   0.0%
0
   0.0%
Week 28: AEs belonging to SMQ Group Number Analyzed 148 participants 144 participants
0
   0.0%
0
   0.0%
Week 30: ISR Number Analyzed 149 participants 144 participants
0
   0.0%
1
   0.7%
Week 30: Medically evaluated Sampson criteria met Number Analyzed 149 participants 144 participants
0
   0.0%
0
   0.0%
Week 30: AEs belonging to SMQ Group Number Analyzed 149 participants 144 participants
0
   0.0%
0
   0.0%
Week 32: ISR Number Analyzed 152 participants 149 participants
0
   0.0%
1
   0.7%
Week 32: Medically evaluated Sampson criteria met Number Analyzed 152 participants 149 participants
0
   0.0%
0
   0.0%
Week 32: AEs belonging to SMQ Group Number Analyzed 152 participants 149 participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP1
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomization in TP2. AEs included both serious and all non-serious AEs. TEAEs and serious TEAEs related to Covid-19 as per investigator's assessment were presented.
Time Frame Day 1 up to maximum of 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.
Arm/Group Title Humira (Adalimumab)
Hide Arm/Group Description:
All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Overall Number of Participants Analyzed 445
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
10
   2.2%
Serious TEAE
6
   1.3%
17.Secondary Outcome
Title Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomization in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs. TEAEs and serious TEAEs related to Covid-19 as per investigator's assessment were presented.
Time Frame Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
20
   9.4%
16
   7.5%
Serious TEAE
1
   0.5%
3
   1.4%
18.Secondary Outcome
Title Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP1
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomization in TP2. Participants who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Participants who discontinued from study due to TEAE were those who had an AE record indicating that the AE caused the participant to be discontinued from the study. TEAEs were related to Covid-19.
Time Frame Day 1 up to maximum of 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.
Arm/Group Title Humira (Adalimumab)
Hide Arm/Group Description:
All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Overall Number of Participants Analyzed 445
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued from treatment due to TEAEs
0
   0.0%
Discontinued from study due to TEAE
6
   1.3%
19.Secondary Outcome
Title Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP2 and Beyond
Hide Description An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAE for TP2 and beyond was defined as any AE that occurred after the first dose of study treatment administration after randomization in TP2 and up to 4 weeks after last dose. AEs included both serious and all non-serious AEs. Participants who discontinued treatment due to TEAEs were those who had an AE record indicating that action taken with study treatment was drug withdrawn but AE did not cause the participant to be discontinued from study. Participants who discontinued from study due to TEAE were those who had an AE record indicating that the AE caused the participant to be discontinued from the study. TEAEs were related to Covid-19.
Time Frame Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Measure Type: Count of Participants
Unit of Measure: Participants
Discontinued from treatment due to TEAEs
0
   0.0%
0
   0.0%
Discontinued from study due to TEAE
3
   1.4%
4
   1.9%
20.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities: TP1
Hide Description Blood samples were collected for the analysis of following laboratory parameters: hematology parameters (hemoglobin, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular hemoglobin concentration platelet count, leukocytes, lymphocytes, neutrophils, eosinophils, monocytes); clinical chemistry parameters (bilirubin, alanine aminotransferase [ALT], blood urea nitrogen [BUN], creatinine, potassium, bicarbonate); urine parameters: urine protein, urine hemoglobin, nitrite, leukocyte esterase and bacteria. Number of participants with any laboratory abnormalities is presented.
Time Frame Day 1 up to maximum of 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Arm/Group Title Humira (Adalimumab)
Hide Arm/Group Description:
All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Overall Number of Participants Analyzed 437
Measure Type: Count of Participants
Unit of Measure: Participants
134
  30.7%
21.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities: TP2 and Beyond
Hide Description Blood samples were collected for the analysis of following laboratory parameters: hematology parameters (hemoglobin, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular hemoglobin concentration platelet count, leukocytes, lymphocytes, neutrophils, eosinophils, monocytes); clinical chemistry parameters (bilirubin, ALT, BUN, creatinine, potassium, bicarbonate); urine parameters: urine protein, urine hemoglobin, nitrite, leukocyte esterase and bacteria. Number of participants with any laboratory abnormalities is presented.
Time Frame Post randomization up to end of study treatment (maximum of 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 211 208
Measure Type: Count of Participants
Unit of Measure: Participants
71
  33.6%
83
  39.9%
22.Secondary Outcome
Title Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond
Hide Description Blood samples were collected for the analysis of following hematology parameters: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Laboratory parameters were graded according to National Cancer Institute-CTC version 4.03 where, Grade 0= within normal limits; Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences and Grade 5: death. Categories with at least 1 non-zero value were reported in this outcome measure.
Time Frame Post randomization up to end of study treatment (maximum of 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each row.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 209 205
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0: Anemia Number Analyzed 209 participants 205 participants
198
  94.7%
190
  92.7%
Grade 0: Hemoglobin increased Number Analyzed 209 participants 205 participants
207
  99.0%
201
  98.0%
Grade 0: Leukocytosis Number Analyzed 209 participants 205 participants
209
 100.0%
205
 100.0%
Grade 0: Lymphocyte count decreased Number Analyzed 209 participants 205 participants
204
  97.6%
200
  97.6%
Grade 0: Lymphocyte count increased Number Analyzed 209 participants 205 participants
203
  97.1%
196
  95.6%
Grade 0: Neutrophil count decreased Number Analyzed 209 participants 204 participants
198
  94.7%
197
  96.6%
Grade 0: Platelet count decreased Number Analyzed 207 participants 204 participants
201
  97.1%
200
  98.0%
Grade 0: White blood cell decreased Number Analyzed 209 participants 205 participants
202
  96.7%
199
  97.1%
Grade 1: Anemia Number Analyzed 209 participants 205 participants
5
   2.4%
7
   3.4%
Grade 1: Hemoglobin increased Number Analyzed 209 participants 205 participants
2
   1.0%
3
   1.5%
Grade 1: Lymphocyte count decreased Number Analyzed 209 participants 205 participants
4
   1.9%
3
   1.5%
Grade 1: Neutrophil count decreased Number Analyzed 209 participants 204 participants
4
   1.9%
3
   1.5%
Grade 1: Platelet count decreased Number Analyzed 207 participants 204 participants
6
   2.9%
4
   2.0%
Grade 1: White blood cell decreased Number Analyzed 209 participants 205 participants
6
   2.9%
6
   2.9%
Grade 2: Anemia Number Analyzed 209 participants 205 participants
6
   2.9%
6
   2.9%
Grade 2: Hemoglobin increased Number Analyzed 209 participants 205 participants
0
   0.0%
1
   0.5%
Grade 2: Lymphocyte count decreased Number Analyzed 209 participants 205 participants
1
   0.5%
2
   1.0%
Grade 2: Lymphocyte count increased Number Analyzed 209 participants 205 participants
6
   2.9%
9
   4.4%
Grade 2: Neutrophil count decreased Number Analyzed 209 participants 204 participants
7
   3.3%
4
   2.0%
Grade 2: White blood cell decreased Number Analyzed 209 participants 205 participants
1
   0.5%
0
   0.0%
Grade 3: Anemia Number Analyzed 209 participants 205 participants
0
   0.0%
2
   1.0%
23.Secondary Outcome
Title Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond
Hide Description Blood samples were collected for analysis of clinical chemistry parameters: ALT increased, alkaline phosphatase increased (ALP), aspartate aminotransferase increased (AST), blood bilirubin increased, creatinine increased, hypercalcemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia. Laboratory parameters were graded according to NCI-CTC version 4.03 where, grade 0= within normal limits; Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences and Grade 5: death. Categories with at least 1 non-zero value were reported.
Time Frame Post randomization up to end of study treatment (maximum of 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each row.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 212 208
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 0: ALT increased Number Analyzed 211 participants 208 participants
169
  80.1%
174
  83.7%
Grade 0: ALP increased Number Analyzed 211 participants 208 participants
202
  95.7%
196
  94.2%
Grade 0: AST increased Number Analyzed 211 participants 208 participants
195
  92.4%
198
  95.2%
Grade 0: Blood bilirubin increased Number Analyzed 211 participants 208 participants
205
  97.2%
204
  98.1%
Grade 0: Creatinine increased Number Analyzed 211 participants 208 participants
171
  81.0%
151
  72.6%
Grade 0: Hypercalcemia Number Analyzed 211 participants 208 participants
211
 100.0%
207
  99.5%
Grade 0: Hyperkalemia Number Analyzed 212 participants 208 participants
208
  98.1%
202
  97.1%
Grade 0: Hypernatremia Number Analyzed 212 participants 208 participants
210
  99.1%
207
  99.5%
Grade 0: Hypoalbuminemia Number Analyzed 212 participants 208 participants
212
 100.0%
208
 100.0%
Grade 0: Hypocalcemia Number Analyzed 211 participants 208 participants
201
  95.3%
202
  97.1%
Grade 0: Hypokalemia Number Analyzed 212 participants 208 participants
210
  99.1%
207
  99.5%
Grade 0: Hyponatremia Number Analyzed 212 participants 208 participants
211
  99.5%
207
  99.5%
Grade 1: ALT increased Number Analyzed 211 participants 208 participants
40
  19.0%
33
  15.9%
Grade 1: ALP increased Number Analyzed 211 participants 208 participants
9
   4.3%
12
   5.8%
Grade 1: AST increased Number Analyzed 211 participants 208 participants
16
   7.6%
10
   4.8%
Grade 1: Blood bilirubin increased Number Analyzed 211 participants 208 participants
5
   2.4%
3
   1.4%
Grade 1: Creatinine increased Number Analyzed 211 participants 208 participants
39
  18.5%
52
  25.0%
Grade 1: Hypercalcemia Number Analyzed 211 participants 208 participants
0
   0.0%
1
   0.5%
Grade 1: Hyperkalemia Number Analyzed 212 participants 208 participants
4
   1.9%
6
   2.9%
Grade 1: Hypernatremia Number Analyzed 212 participants 208 participants
2
   0.9%
1
   0.5%
Grade 1: Hypocalcemia Number Analyzed 211 participants 208 participants
10
   4.7%
6
   2.9%
Grade 1: Hyponatremia Number Analyzed 212 participants 208 participants
1
   0.5%
1
   0.5%
Grade 2: ALT increased Number Analyzed 211 participants 208 participants
2
   0.9%
1
   0.5%
Grade 2: Blood bilirubin increased Number Analyzed 211 participants 208 participants
1
   0.5%
1
   0.5%
Grade 2: Creatinine increased Number Analyzed 211 participants 208 participants
1
   0.5%
5
   2.4%
Grade 2: Hypokalemia Number Analyzed 212 participants 208 participants
2
   0.9%
1
   0.5%
24.Secondary Outcome
Title Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond
Hide Description In this outcome measure, liver function laboratory parameters, which included: normal bilirubin and AST/ALT, Temple's Corollary (AST/ALT [more than or equal to] >=3*upper limit normal [ULN] and normal bilirubin), Gilbert's Syndrome or cholestasis (normal AST/ALT and bilirubin >=2*ULN) and Potential Hy's Law Cases (AST/ALT >=3*ULN and Bilirubin>=2*ULN) according to eDISH criteria, were reported.
Time Frame Post randomization up to end of study treatment (maximum of 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 211 208
Measure Type: Count of Participants
Unit of Measure: Participants
Normal Bilirubin and AST/ALT
208
  98.6%
207
  99.5%
Temple's Corollary (AST/ALT >=3* upper limit normal [ULN] and Normal Bilirubin)
2
   0.9%
1
   0.5%
Gilbert's Syndrome or Cholestasis (Normal AST/ALT and Bilirubin >=2*ULN)
1
   0.5%
0
   0.0%
Potential Hy's Law Cases (AST/ALT >=3*ULN and Bilirubin>=2*ULN)
0
   0.0%
0
   0.0%
25.Secondary Outcome
Title Baseline, Absolute Week 32 Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Change From Baseline in SBP, DBP at Week 32 (EOT/ ET)
Hide Description SBP and DBP were measured in a supine position using an automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
Time Frame Baseline and Week 32 (end of treatment [EOT]/early termination [ET])
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 212 209
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury
SBP: Baseline 125.7  (12.72) 125.9  (11.49)
SBP: Absolute value at Week 32 (EOT/ET) 126.0  (11.20) 126.2  (12.69)
SBP: Change at Week 32 (EOT/ET) 0.3  (11.49) 0.4  (11.28)
DBP: Baseline 78.1  (8.31) 77.7  (7.60)
DBP: Absolute value at Week 32 (EOT/ET) 78.6  (7.77) 77.5  (7.54)
DBP: Change at Week 32 (EOT/ET) 0.5  (8.04) -0.2  (8.32)
26.Secondary Outcome
Title Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)
Hide Description Pulse rate was measured in a supine position using an automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
Time Frame Baseline and Week 32 (EOT/ET)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 212 209
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Baseline 73.6  (8.55) 73.2  (8.42)
Absolute value at Week 32 (EOT/ET) 73.6  (7.94) 73.1  (7.98)
Change at Week 32 (EOT/ET) 0.1  (8.55) -0.2  (7.68)
27.Secondary Outcome
Title Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET)
Hide Description Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
Time Frame Baseline and Week 32 (EOT/ET)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 212 209
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Baseline 36.5  (0.27) 36.5  (0.27)
Absolute value at Week 32 (EOT/ET) 36.4  (0.26) 36.4  (0.20)
Change at Week 32 (EOT/ET) -0.0  (0.28) -0.0  (0.27)
28.Secondary Outcome
Title Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET)
Hide Description Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
Time Frame Baseline and Week 32 (EOT/ET)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 212 209
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
Baseline 16.6  (1.75) 16.6  (2.10)
Absolute value at Week 32 (EOT/ET) 16.5  (1.81) 16.6  (2.00)
Change at Week 32 (EOT/ET) -0.1  (1.36) -0.0  (1.52)
29.Secondary Outcome
Title Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive
Hide Description Serum samples were analyzed using a validated electrochemoluminescent (ECL) immunoassay for ADA assessment. Samples positive for ADA were further tested for neutralizing activity using a validated cell based NAb assay. ADA positive was defined as ADA titer >=1.88 while NAb positive was defined as NAb titer >=0.70.
Time Frame Week 10, 16, 22, 24, 26, 28, 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10. For ADA: "Number Analyzed" = all participants assessed for ADA measurement at specific time points. For Nab: "Number Analyzed" = all participants with ADA positive results assessed for Nab measurement at specific time points.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Measure Type: Count of Participants
Unit of Measure: Participants
Week 10: ADA positive Number Analyzed 213 participants 214 participants
55
  25.8%
59
  27.6%
Week 10: NAb positive Number Analyzed 55 participants 59 participants
22
  40.0%
19
  32.2%
Week 16: ADA positive Number Analyzed 213 participants 214 participants
88
  41.3%
97
  45.3%
Week 16: NAb positive Number Analyzed 88 participants 97 participants
22
  25.0%
21
  21.6%
Week 22: ADA positive Number Analyzed 213 participants 214 participants
96
  45.1%
106
  49.5%
Week 22: NAb positive Number Analyzed 96 participants 106 participants
24
  25.0%
20
  18.9%
Week 24: ADA positive Number Analyzed 213 participants 214 participants
102
  47.9%
100
  46.7%
Week 24: NAb positive Number Analyzed 102 participants 100 participants
19
  18.6%
20
  20.0%
Week 26: ADA positive Number Analyzed 213 participants 214 participants
101
  47.4%
105
  49.1%
Week 26: NAb positive Number Analyzed 101 participants 105 participants
21
  20.8%
15
  14.3%
Week 28: ADA positive Number Analyzed 213 participants 214 participants
102
  47.9%
105
  49.1%
Week 28: NAb positive Number Analyzed 102 participants 105 participants
18
  17.6%
16
  15.2%
Week 30: ADA positive Number Analyzed 213 participants 214 participants
103
  48.4%
109
  50.9%
Week 30: NAb positive Number Analyzed 103 participants 109 participants
17
  16.5%
19
  17.4%
Week 32: ADA positive Number Analyzed 213 participants 214 participants
100
  46.9%
104
  48.6%
Week 32: NAb positive Number Analyzed 100 participants 104 participants
18
  18.0%
18
  17.3%
30.Secondary Outcome
Title Mean ADA Titers
Hide Description Serum samples were analyzed using a validated ECL immunoassay for ADA assessment. Endpoint titer was defined as log10 of the reciprocal of the ADA serum dilution at which the sample response was equal to the cut-point of the assay.
Time Frame Week 10, 16, 22, 24, 26, 28, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10. Here, 'Number Analyzed' signifies participants evaluable with ADA non-missing values at specific time points.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Mean (Standard Deviation)
Unit of Measure: log10 titer
Week 10 Number Analyzed 211 participants 214 participants
0.830  (1.46534) 0.880  (1.51789)
Week 16 Number Analyzed 210 participants 209 participants
1.385  (1.71192) 1.546  (1.75299)
Week 22 Number Analyzed 208 participants 202 participants
1.570  (1.77364) 1.784  (1.79136)
Week 24 Number Analyzed 207 participants 199 participants
1.674  (1.78148) 1.709  (1.78301)
Week 26 Number Analyzed 204 participants 198 participants
1.671  (1.77780) 1.806  (1.78134)
Week 28 Number Analyzed 205 participants 197 participants
1.670  (1.77759) 1.788  (1.77325)
Week 30 Number Analyzed 206 participants 198 participants
1.658  (1.75135) 1.854  (1.78187)
Week 32 Number Analyzed 199 participants 193 participants
1.677  (1.76060) 1.846  (1.81474)
31.Secondary Outcome
Title Mean NAb Titers
Hide Description Serum samples were analyzed using a validated ECL immunoassay for ADA assessment. Endpoint titer was defined as log10 of the reciprocal of the NAb serum dilution at which the sample response was equal to the cut-point of the assay.
Time Frame Week 10, 16, 22, 24, 26, 28, 30, 32
Hide Outcome Measure Data
Hide Analysis Population Description
Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10. Here, 'Number Analyzed' signifies participants evaluable with NAb non-missing values at specific time points.
Arm/Group Title Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description:
Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.
Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Number of Participants Analyzed 213 214
Mean (Standard Deviation)
Unit of Measure: log10 titer
Week 10 Number Analyzed 55 participants 58 participants
0.712  (1.02024) 0.718  (1.14660)
Week 16 Number Analyzed 88 participants 97 participants
0.467  (0.90051) 0.443  (0.92450)
Week 22 Number Analyzed 96 participants 106 participants
0.488  (0.91641) 0.405  (0.89940)
Week 24 Number Analyzed 102 participants 100 participants
0.396  (0.87759) 0.409  (0.90030)
Week 26 Number Analyzed 101 participants 105 participants
0.420  (0.90500) 0.328  (0.84792)
Week 28 Number Analyzed 102 participants 105 participants
0.360  (0.83177) 0.353  (0.88464)
Week 30 Number Analyzed 103 participants 109 participants
0.359  (0.87754) 0.377  (0.91439)
Week 32 Number Analyzed 100 participants 104 participants
0.341  (0.81482) 0.362  (0.88055)
Time Frame TP1: Day 1 up to maximum of 10 Weeks TP2 and beyond: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Adverse Event Reporting Description Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. As planned, AE were analyzed for TP1 using the Safety-TP1 population for the Humira arm. AE analyses for TP2 and beyond were performed using Safety-randomized population for switching arm and non-switching arm.
 
Arm/Group Title Humira (Adalimumab) Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Hide Arm/Group Description All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1. Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose. Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
All-Cause Mortality
Humira (Adalimumab) Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/445 (0.00%)   0/213 (0.00%)   0/214 (0.00%) 
Hide Serious Adverse Events
Humira (Adalimumab) Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/445 (2.92%)   3/213 (1.41%)   8/214 (3.74%) 
Blood and lymphatic system disorders       
Blood loss anaemia * 1  0/445 (0.00%)  0/213 (0.00%)  1/214 (0.47%) 
Eye disorders       
Keratitis * 1  0/445 (0.00%)  1/213 (0.47%)  0/214 (0.00%) 
Hepatobiliary disorders       
Cholelithiasis * 1  1/445 (0.22%)  0/213 (0.00%)  0/214 (0.00%) 
Cholecystitis acute * 1  0/445 (0.00%)  0/213 (0.00%)  1/214 (0.47%) 
Infections and infestations       
COVID-19 * 1  5/445 (1.12%)  0/213 (0.00%)  1/214 (0.47%) 
COVID-19 pneumonia * 1  1/445 (0.22%)  1/213 (0.47%)  2/214 (0.93%) 
Influenza * 1  1/445 (0.22%)  0/213 (0.00%)  0/214 (0.00%) 
Lyme disease * 1  2/445 (0.45%)  0/213 (0.00%)  0/214 (0.00%) 
Pneumonia * 1  1/445 (0.22%)  0/213 (0.00%)  1/214 (0.47%) 
Abscess limb * 1  0/445 (0.00%)  1/213 (0.47%)  0/214 (0.00%) 
Injury, poisoning and procedural complications       
Subdural haemorrhage * 1  0/445 (0.00%)  0/213 (0.00%)  1/214 (0.47%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/445 (0.22%)  0/213 (0.00%)  0/214 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Ovarian cancer metastatic * 1  1/445 (0.22%)  0/213 (0.00%)  0/214 (0.00%) 
Nervous system disorders       
Ischaemic stroke * 1  0/445 (0.00%)  0/213 (0.00%)  1/214 (0.47%) 
Reproductive system and breast disorders       
Heavy menstrual bleeding * 1  1/445 (0.22%)  0/213 (0.00%)  0/214 (0.00%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Humira (Adalimumab) Switching Arm: Humira and PF-06410293 (Adalimumab) Non-switching Arm: Humira (Adalimumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/445 (6.29%)   46/213 (21.60%)   38/214 (17.76%) 
Gastrointestinal disorders       
Abdominal pain upper * 1  0/445 (0.00%)  3/213 (1.41%)  0/214 (0.00%) 
General disorders       
Injection site reaction * 1  13/445 (2.92%)  6/213 (2.82%)  4/214 (1.87%) 
Swelling * 1  0/445 (0.00%)  3/213 (1.41%)  1/214 (0.47%) 
Infections and infestations       
Urinary tract infection * 1  5/445 (1.12%)  4/213 (1.88%)  3/214 (1.40%) 
COVID-19 * 1  0/445 (0.00%)  16/213 (7.51%)  9/214 (4.21%) 
Nasopharyngitis * 1  0/445 (0.00%)  0/213 (0.00%)  7/214 (3.27%) 
Upper respiratory tract infection * 1  0/445 (0.00%)  3/213 (1.41%)  3/214 (1.40%) 
Investigations       
SARS-CoV-2 test positive * 1  9/445 (2.02%)  18/213 (8.45%)  14/214 (6.54%) 
Alanine aminotransferase increased * 1  0/445 (0.00%)  3/213 (1.41%)  1/214 (0.47%) 
Aspartate aminotransferase increased * 1  0/445 (0.00%)  3/213 (1.41%)  1/214 (0.47%) 
Musculoskeletal and connective tissue disorders       
Rheumatoid arthritis * 1  0/445 (0.00%)  3/213 (1.41%)  1/214 (0.47%) 
Nervous system disorders       
Headache * 1  0/445 (0.00%)  4/213 (1.88%)  4/214 (1.87%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  0/445 (0.00%)  3/213 (1.41%)  1/214 (0.47%) 
Skin and subcutaneous tissue disorders       
Erythema * 1  10/445 (2.25%)  6/213 (2.82%)  4/214 (1.87%) 
Pruritus * 1  7/445 (1.57%)  0/213 (0.00%)  0/214 (0.00%) 
Rash * 1  0/445 (0.00%)  3/213 (1.41%)  0/214 (0.00%) 
Vascular disorders       
Hypertension * 1  0/445 (0.00%)  2/213 (0.94%)  5/214 (2.34%) 
1
Term from vocabulary, MedDRA v24.0
*
Indicates events were collected by non-systematic assessment
In participant flow, there were discontinuations due to AEs, which were captured within different reasons for discontinuations (e.g. other, physician decision etc.) as the study case report form (CRF) page did not include AE as an option for sites to record if the discontinuation was truly due to AE.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04230213    
Other Study ID Numbers: B5381012
2019-000284-24 ( EudraCT Number )
B5381012 ( Other Identifier: Alias Study Number )
First Submitted: January 14, 2020
First Posted: January 18, 2020
Results First Submitted: June 17, 2022
Results First Posted: August 22, 2022
Last Update Posted: August 22, 2022