A Phase 3 interventional study of PF-06410293 and adalimumab in Rheumatoid Arthritis, sponsored by Pfizer. Completed at 72 sites in 10 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The study will assess the impact of pharmacokinetics (PK), safety and immunogenicity after switches between PF-06410293 and adalimumab and with continuous dosing with adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 455 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-Evidence of untreated or inadequately treated latent or active TB.
Subcutaneous (SC) injection given every other week
Drug: PF-06410293 · Drug: adalimumab
SC injection given every other week
Drug: adalimumab
SC injection
SC injection
Also known as: Humira ®
Maximum Observed Serum Concentration (Cmax) of Adalimumab
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)
Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab
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)
Time to Reach Cmax (Tmax) of Adalimumab
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)
Average Serum Concentration (Cav) of Adalimumab
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)
Apparent Clearance (CL/F) of Serum Adalimumab
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)
Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab
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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1
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
Number of Participants With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond
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)
Number of Participants With Grade 3 or Higher TEAEs: TP1
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
Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond
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)
Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP1
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
Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP2 and Beyond
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)
Number of Participants With TEAEs of Special Interest: TP2 and Beyond
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)
Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1
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
Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1
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
Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP1
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
Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond
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)
Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP1
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
Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP2 and Beyond
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)
Number of Participants With Laboratory Abnormalities: TP1
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
Number of Participants With Laboratory Abnormalities: TP2 and Beyond
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)
Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond
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)
Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond
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)
Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond
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)
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)
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])
Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)
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)
Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET)
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)
Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET)
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)
Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive
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
Mean ADA Titers
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
Mean NAb Titers
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
| Milestone | Humira (Adalimumab) | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|---|
| Started | 445 | 0 | 0 |
| Completed | 427 | 0 | 0 |
| Not completed | 18 | 0 | 0 |
| Withdrew: Other | 8 | 0 | 0 |
| Withdrew: Withdrawal by subject | 7 | 0 | 0 |
| Withdrew: Physician decision | 3 | 0 | 0 |
| Milestone | Humira (Adalimumab) | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|---|
| Started | 0 | 213 | 214 |
| Completed | 0 | 211 | 211 |
| Not completed | 0 | 2 | 3 |
| Withdrew: Other | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 |
| Milestone | Humira (Adalimumab) | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|---|
| Started | 0 | 211 | 211 |
| Completed | 0 | 210 | 204 |
| Not completed | 0 | 1 | 7 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Other | 0 | 1 | 3 |
| Milestone | Humira (Adalimumab) | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|---|
| Started | 0 | 210 | 204 |
| Completed | 0 | 202 | 196 |
| Not completed | 0 | 8 | 8 |
| Withdrew: Other | 0 | 5 | 5 |
| Withdrew: Withdrawal by subject | 0 | 1 | 2 |
| Withdrew: Physician decision | 0 | 2 | 1 |
| Milestone | Humira (Adalimumab) | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|---|
| Started | 0 | 202 | 196 |
| Completed | 0 | 201 | 194 |
| Not completed | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Withdrew: Other | 0 | 1 | 1 |
Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.
| Micrograms per milliliter | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Adalimumab | 9.156 ± 97 | 8.974 ± 97 |
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.
| Micrograms*hour per milliliter | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab | 2472 ± 129 | 2365 ± 133 |
Tmax is the time taken (in hours) to reach the maximum serum drug concentration.
| Hours | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Time to Reach Cmax (Tmax) of Adalimumab | 71.80 (0.000 to 336) | 72.00 (0.000 to 337) |
Cav was defined as average serum concentration over the dosing interval. The geometric coefficient of variation is expressed in percentage.
| Micrograms per milliliter | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Average Serum Concentration (Cav) of Adalimumab | 7.357 ± 130 | 7.040 ± 133 |
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.
| Milliliter per hour | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Apparent Clearance (CL/F) of Serum Adalimumab | 16.19 ± 129 | 16.91 ± 133 |
Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.
| Micrograms per milliliter | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Day 1 | 0.03102 ± 0.15291 | 0.05703 ± 0.29719 |
| Day 71 | 6.999 ± 4.4196 | 6.675 ± 4.3310 |
| Day 113 | 7.763 ± 5.0812 | 7.374 ± 4.8807 |
| Day 155 | 7.900 ± 5.2493 | 7.558 ± 5.0502 |
| Day 169 | 7.918 ± 5.1756 | 7.767 ± 5.1860 |
| Day 183 | 8.259 ± 5.3404 | 7.933 ± 5.1299 |
| Day 197 | 8.347 ± 5.5458 | 8.022 ± 5.2046 |
| Day 211 | 8.477 ± 5.4604 | 7.891 ± 5.1818 |
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.
| Participants | Humira (Adalimumab) |
|---|---|
| TEAEs | 107 |
| Serious TEAEs | 13 |
| Treatment related TEAEs | 31 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| TEAEs | 82 | 62 |
| Serious TEAEs | 3 | 8 |
| Treatment related TEAEs | 19 | 10 |
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.
| Participants | Humira (Adalimumab) |
|---|---|
| Number of Participants With Grade 3 or Higher TEAEs: TP1 | 14 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond | 5 | 8 |
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.
| Participants | Humira (Adalimumab) |
|---|---|
| Discontinued from treatment due to TEAEs | 3 |
| Discontinued from study due to TEAE | 12 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Discontinued from treatment due to TEAEs | 0 | 3 |
| Discontinued from study due to TEAEs | 8 | 9 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Number of Participants With TEAEs of Special Interest: TP2 and Beyond | 58 | 47 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Week 16: ISR | 0 | 1 |
| Week 16: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 16: AEs belonging to SMQ Group | 0 | 0 |
| Week 22: ISR | 0 | 1 |
| Week 22: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 22: AEs belonging to SMQ Group | 0 | 0 |
| Week 24: ISR | 0 | 1 |
| Week 24: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 24: AEs belonging to SMQ Group | 0 | 1 |
| Week 26: ISR | 1 | 1 |
| Week 26: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 26: AEs belonging to SMQ Group | 0 | 0 |
| Week 28: ISR | 0 | 1 |
| Week 28: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 28: AEs belonging to SMQ Group | 0 | 0 |
| Week 30: ISR | 0 | 1 |
| Week 30: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 30: AEs belonging to SMQ Group | 1 | 0 |
| Week 32: ISR | 0 | 0 |
| Week 32: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 32: AEs belonging to SMQ Group | 0 | 0 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Week 16: ISR | 4 | 2 |
| Week 16: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 16: AEs belonging to SMQ Group | 0 | 0 |
| Week 22: ISR | 1 | 1 |
| Week 22: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 22: AEs belonging to SMQ Group | 0 | 0 |
| Week 24: ISR | 0 | 2 |
| Week 24: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 24: AEs belonging to SMQ Group | 0 | 0 |
| Week 26: ISR | 0 | 2 |
| Week 26: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 26: AEs belonging to SMQ Group | 0 | 0 |
| Week 28: ISR | 0 | 1 |
| Week 28: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 28: AEs belonging to SMQ Group | 0 | 0 |
| Week 30: ISR | 0 | 1 |
| Week 30: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 30: AEs belonging to SMQ Group | 0 | 0 |
| Week 32: ISR | 0 | 1 |
| Week 32: Medically evaluated Sampson criteria met | 0 | 0 |
| Week 32: AEs belonging to SMQ Group | 0 | 0 |
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.
| Participants | Humira (Adalimumab) |
|---|---|
| TEAE | 10 |
| Serious TEAE | 6 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| TEAE | 20 | 16 |
| Serious TEAE | 1 | 3 |
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.
| Participants | Humira (Adalimumab) |
|---|---|
| Discontinued from treatment due to TEAEs | 0 |
| Discontinued from study due to TEAE | 6 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Discontinued from treatment due to TEAEs | 0 | 0 |
| Discontinued from study due to TEAE | 3 | 4 |
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.
| Participants | Humira (Adalimumab) |
|---|---|
| Number of Participants With Laboratory Abnormalities: TP1 | 134 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Number of Participants With Laboratory Abnormalities: TP2 and Beyond | 71 | 83 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Grade 0: Anemia | 198 | 190 |
| Grade 0: Hemoglobin increased | 207 | 201 |
| Grade 0: Leukocytosis | 209 | 205 |
| Grade 0: Lymphocyte count decreased | 204 | 200 |
| Grade 0: Lymphocyte count increased | 203 | 196 |
| Grade 0: Neutrophil count decreased | 198 | 197 |
| Grade 0: Platelet count decreased | 201 | 200 |
| Grade 0: White blood cell decreased | 202 | 199 |
| Grade 1: Anemia | 5 | 7 |
| Grade 1: Hemoglobin increased | 2 | 3 |
| Grade 1: Lymphocyte count decreased | 4 | 3 |
| Grade 1: Neutrophil count decreased | 4 | 3 |
| Grade 1: Platelet count decreased | 6 | 4 |
| Grade 1: White blood cell decreased | 6 | 6 |
| Grade 2: Anemia | 6 | 6 |
| Grade 2: Hemoglobin increased | 0 | 1 |
| Grade 2: Lymphocyte count decreased | 1 | 2 |
| Grade 2: Lymphocyte count increased | 6 | 9 |
| Grade 2: Neutrophil count decreased | 7 | 4 |
| Grade 2: White blood cell decreased | 1 | 0 |
| Grade 3: Anemia | 0 | 2 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Grade 0: ALT increased | 169 | 174 |
| Grade 0: ALP increased | 202 | 196 |
| Grade 0: AST increased | 195 | 198 |
| Grade 0: Blood bilirubin increased | 205 | 204 |
| Grade 0: Creatinine increased | 171 | 151 |
| Grade 0: Hypercalcemia | 211 | 207 |
| Grade 0: Hyperkalemia | 208 | 202 |
| Grade 0: Hypernatremia | 210 | 207 |
| Grade 0: Hypoalbuminemia | 212 | 208 |
| Grade 0: Hypocalcemia | 201 | 202 |
| Grade 0: Hypokalemia | 210 | 207 |
| Grade 0: Hyponatremia | 211 | 207 |
| Grade 1: ALT increased | 40 | 33 |
| Grade 1: ALP increased | 9 | 12 |
| Grade 1: AST increased | 16 | 10 |
| Grade 1: Blood bilirubin increased | 5 | 3 |
| Grade 1: Creatinine increased | 39 | 52 |
| Grade 1: Hypercalcemia | 0 | 1 |
| Grade 1: Hyperkalemia | 4 | 6 |
| Grade 1: Hypernatremia | 2 | 1 |
| Grade 1: Hypocalcemia | 10 | 6 |
| Grade 1: Hyponatremia | 1 | 1 |
| Grade 2: ALT increased | 2 | 1 |
| Grade 2: Blood bilirubin increased | 1 | 1 |
| Grade 2: Creatinine increased | 1 | 5 |
| Grade 2: Hypokalemia | 2 | 1 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Normal Bilirubin and AST/ALT | 208 | 207 |
| Temple's Corollary (AST/ALT >=3* upper limit normal [ULN] and Normal Bilirubin) | 2 | 1 |
| Gilbert's Syndrome or Cholestasis (Normal AST/ALT and Bilirubin >=2*ULN) | 1 | 0 |
| Potential Hy's Law Cases (AST/ALT >=3*ULN and Bilirubin>=2*ULN) | 0 | 0 |
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.
| Millimeter of mercury | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| 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 |
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.
| Beats per minute | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| 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 |
Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
| Degree Celsius | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| 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 |
Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
| Breaths per minute | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| 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 |
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.
| Participants | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Week 10: ADA positive | 55 | 59 |
| Week 10: NAb positive | 22 | 19 |
| Week 16: ADA positive | 88 | 97 |
| Week 16: NAb positive | 22 | 21 |
| Week 22: ADA positive | 96 | 106 |
| Week 22: NAb positive | 24 | 20 |
| Week 24: ADA positive | 102 | 100 |
| Week 24: NAb positive | 19 | 20 |
| Week 26: ADA positive | 101 | 105 |
| Week 26: NAb positive | 21 | 15 |
| Week 28: ADA positive | 102 | 105 |
| Week 28: NAb positive | 18 | 16 |
| Week 30: ADA positive | 103 | 109 |
| Week 30: NAb positive | 17 | 19 |
| Week 32: ADA positive | 100 | 104 |
| Week 32: NAb positive | 18 | 18 |
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.
| log10 titer | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Week 10 | 0.830 ± 1.46534 | 0.880 ± 1.51789 |
| Week 16 | 1.385 ± 1.71192 | 1.546 ± 1.75299 |
| Week 22 | 1.570 ± 1.77364 | 1.784 ± 1.79136 |
| Week 24 | 1.674 ± 1.78148 | 1.709 ± 1.78301 |
| Week 26 | 1.671 ± 1.77780 | 1.806 ± 1.78134 |
| Week 28 | 1.670 ± 1.77759 | 1.788 ± 1.77325 |
| Week 30 | 1.658 ± 1.75135 | 1.854 ± 1.78187 |
| Week 32 | 1.677 ± 1.76060 | 1.846 ± 1.81474 |
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.
| log10 titer | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|
| Week 10 | 0.712 ± 1.02024 | 0.718 ± 1.14660 |
| Week 16 | 0.467 ± 0.90051 | 0.443 ± 0.92450 |
| Week 22 | 0.488 ± 0.91641 | 0.405 ± 0.89940 |
| Week 24 | 0.396 ± 0.87759 | 0.409 ± 0.90030 |
| Week 26 | 0.420 ± 0.90500 | 0.328 ± 0.84792 |
| Week 28 | 0.360 ± 0.83177 | 0.353 ± 0.88464 |
| Week 30 | 0.359 ± 0.87754 | 0.377 ± 0.91439 |
| Week 32 | 0.341 ± 0.81482 | 0.362 ± 0.88055 |
Collected over 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). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Humira (Adalimumab) | 0/445 (0%) | 13/445 (2.9%) | 28/445 (6.3%) |
| Switching Arm: Humira and PF-06410293 (Adalimumab) | 0/213 (0%) | 3/213 (1.4%) | 46/213 (21.6%) |
| Non-switching Arm: Humira (Adalimumab) | 0/214 (0%) | 8/214 (3.7%) | 38/214 (17.8%) |
| Event | Humira (Adalimumab) | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|---|
| COVID-19Infections and infestations | 5/445 | 0/213 | 1/214 |
| COVID-19 pneumoniaInfections and infestations | 1/445 | 1/213 | 2/214 |
| KeratitisEye disorders | 0/445 | 1/213 | 0/214 |
| Abscess limbInfections and infestations | 0/445 | 1/213 | 0/214 |
| PneumoniaInfections and infestations | 1/445 | 0/213 | 1/214 |
| Blood loss anaemiaBlood and lymphatic system disorders | 0/445 | 0/213 | 1/214 |
| Cholecystitis acuteHepatobiliary disorders | 0/445 | 0/213 | 1/214 |
| Subdural haemorrhageInjury, poisoning and procedural complications | 0/445 | 0/213 | 1/214 |
| Ischaemic strokeNervous system disorders | 0/445 | 0/213 | 1/214 |
| Lyme diseaseInfections and infestations | 2/445 | 0/213 | 0/214 |
| Event | Humira (Adalimumab) | Switching Arm: Humira and PF-06410293 (Adalimumab) | Non-switching Arm: Humira (Adalimumab) |
|---|---|---|---|
| SARS-CoV-2 test positiveInvestigations | 9/445 | 18/213 | 14/214 |
| COVID-19Infections and infestations | 0/445 | 16/213 | 9/214 |
| NasopharyngitisInfections and infestations | 0/445 | 0/213 | 7/214 |
| Injection site reactionGeneral disorders | 13/445 | 6/213 | 4/214 |
| ErythemaSkin and subcutaneous tissue disorders | 10/445 | 6/213 | 4/214 |
| HypertensionVascular disorders | 0/445 | 2/213 | 5/214 |
| Urinary tract infectionInfections and infestations | 5/445 | 4/213 | 3/214 |
| HeadacheNervous system disorders | 0/445 | 4/213 | 4/214 |
| PruritusSkin and subcutaneous tissue disorders | 7/445 | 0/213 | 0/214 |
| SwellingGeneral disorders | 0/445 | 3/213 | 1/214 |
Baseline analysis population included all the participants who were enrolled in TP1.
| Age, Continuous(Years) | Humira (Adalimumab) |
|---|---|
| Lead-In TP1: Humira (Adalimumab) | 53.60 ± 11.17 |
| Switching arm: Humira and PF-06410293 (Adalimumab) | 53.60 ± 11.26 |
| Non-Switching arm: Humira (Adalimumab) | 53.35 ± 11.30 |
| Sex: Female, Male(Participants) | Humira (Adalimumab) |
|---|---|
| Lead-In TP1: Humira (Adalimumab) — Female | 368 |
| Lead-In TP1: Humira (Adalimumab) — Male | 77 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Female | 175 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Male | 38 |
| Non-Switching arm: Humira (Adalimumab) — Female | 179 |
| Non-Switching arm: Humira (Adalimumab) — Male | 35 |
| Ethnicity (NIH/OMB)(Participants) | Humira (Adalimumab) |
|---|---|
| Lead-In TP1: Humira (Adalimumab) — Hispanic or Latino | 4 |
| Lead-In TP1: Humira (Adalimumab) — Not Hispanic or Latino | 440 |
| Lead-In TP1: Humira (Adalimumab) — Unknown or Not Reported | 1 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Hispanic or Latino | 2 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Not Hispanic or Latino | 210 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Unknown or Not Reported | 1 |
| Non-Switching arm: Humira (Adalimumab) — Hispanic or Latino | 1 |
| Non-Switching arm: Humira (Adalimumab) — Not Hispanic or Latino | 213 |
| Non-Switching arm: Humira (Adalimumab) — Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Humira (Adalimumab) |
|---|---|
| Lead-In TP1: Humira (Adalimumab) — American Indian or Alaska Native | 0 |
| Lead-In TP1: Humira (Adalimumab) — Asian | 0 |
| Lead-In TP1: Humira (Adalimumab) — Native Hawaiian or Other Pacific Islander | 0 |
| Lead-In TP1: Humira (Adalimumab) — Black or African American | 2 |
| Lead-In TP1: Humira (Adalimumab) — White | 440 |
| Lead-In TP1: Humira (Adalimumab) — More than one race | 0 |
| Lead-In TP1: Humira (Adalimumab) — Unknown or Not Reported | 3 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — American Indian or Alaska Native | 0 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Asian | 0 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Native Hawaiian or Other Pacific Islander | 0 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Black or African American | 0 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — White | 212 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — More than one race | 0 |
| Switching arm: Humira and PF-06410293 (Adalimumab) — Unknown or Not Reported | 1 |
| Non-Switching arm: Humira (Adalimumab) — American Indian or Alaska Native | 0 |
| Non-Switching arm: Humira (Adalimumab) — Asian | 0 |
| Non-Switching arm: Humira (Adalimumab) — Native Hawaiian or Other Pacific Islander | 0 |
| Non-Switching arm: Humira (Adalimumab) — Black or African American | 0 |
| Non-Switching arm: Humira (Adalimumab) — White | 210 |
| Non-Switching arm: Humira (Adalimumab) — More than one race | 2 |
| Non-Switching arm: Humira (Adalimumab) — Unknown or Not Reported | 2 |
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Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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