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

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: PF-06410293; Drug: adalimumab

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Center of the Republic of Srpska
  • Gradiska, Bosnia and Herzegovina, 78400
    • Health center Gradiska
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinical Center University of Sarajevo
  • Sarajevo, Bosnia and Herzegovina, 71000
    • General Hospital Prim. Dr.Abdulah Nakas
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT "Dr Georgi Stranski" EAD
  • Plovdiv, Bulgaria, 4002
    • DCC Sveti Georgi
  • Plovdiv, Bulgaria, 4023
    • Unimed Medical Centre
• Czechia
  • Brno, Czechia, 615 00
    • Revmacentrum MUDr. Mostera, s.r.o.
  • Brno, Czechia, 602 00
    • iMedica s.r.o.
  • Brno, Czechia, 602 00
    • Lekarna Na Lidicke
  • Brno, Czechia, 60200
    • Lekarna Biovita
  • Brno, Czechia, 613 00
    • X-Medica, s.r.o.
  • Hlucin, Czechia, 748 01
    • L.K.N. Arthrocentrum, s.r.o.
  • Hlucin, Czechia, 748 01
    • Plicni ambulance
  • Olomouc, Czechia, 779 00
    • Chirurgie Sibenik
  • Olomouc, Czechia, 779 00
    • CTCenter MaVe s.r.o
  • Olomouc, Czechia, 779 00
    • Lekarna u Pottingea
  • Ostrava, Czechia, 702 00
    • Lekarna Vesalion
  • Pardubice, Czechia, 530 02
    • CCR Czech a.s.
  • Pardubice, Czechia, 530 02
    • Lekarna BENU
  • Praha, Czechia, 101 00
    • Lekarna Pod Platany
  • Praha, Czechia, 130 00
    • CCR Prague s.r.o.
  • Praha, Czechia, 13000
    • Diagnostické centrum Olšanská s.r.o.
  • Praha 2, Czechia, 12850
    • Revmatologicky ustav
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Uherske Hradiste, Czechia, 68601
    • Medical Plus S.R.O.
  • Uherske Hradiste, Czechia, 68601
    • Lekarna Hradebni s.r.o.
  • Uherske Hradiste, Czechia, 68601
    • Radiodiagnosticka ordinace a pracoviste
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Hospital of Lithuanian University of Health Sciences, Kauno klinikos
  • Klaipeda, Lithuania, LT-92288
    • Klaipeda University Hospital
• Poland
  • Bialystok, Poland, 15-099
    • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
  • Bialystok, Poland, 15-351
    • NZOZ Osteo-Medic s.c. A.Racewicz, J. Supronik
  • Krakow, Poland, 30-510
    • Pratia McM Kraków
  • Krakow, Poland, 30-002
    • Małopolskie Badania Kliniczne Sp. z o. o. Sp. k.
  • Lublin, Poland, 20-582
    • Zespol Poradni Specjalistycznych REUMED
  • Nadarzyn, Poland, 05-830
    • NZOZ Lecznica MAK-MED s.c.
  • Nowa Sol, Poland, 67-100
    • Twoja Przychodnia Centrum Medyczne Nowa Sol
  • Poznan, Poland, 61-397
    • Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
  • Torun, Poland, 87-100
    • Nasz Lekarz Przychodnie Medyczne
  • Warszawa, Poland, 02-118
    • Rheuma Medicus Zaklad Opieki Zdrowotnej
• Russian Federation
  • Moscow, Russian Federation, 101000
    • Limited Liability Company "Clinic on Maroseyka"
  • Novosibirsk, Russian Federation, 630099
    • Limited Liability Company Consultative and Diagnostic Rheumatological Center "Healthy Joints"
  • Orenburg, Russian Federation, 460000
    • FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
  • Orenburg, Russian Federation, 460018
    • GBUZ "Orenburg Regional Clinical Hospital"
  • Petrozavodsk, Russian Federation, 185910
    • SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
  • Ryazan, Russian Federation, 390026
    • FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
  • Ryazan, Russian Federation, 390026
    • SBI of the Ryazan Region "Regional Clinical Cardiology dispensary"
  • Ryazan, Russian Federation, 390039
    • SBI of Ryazan Region "Regional Clinical Hospital"
  • Smolensk, Russian Federation, 214018
    • Smolensk Regional Clinical Hospital
  • Smolensk, Russian Federation, 214019
    • FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
  • Vladimir, Russian Federation, 600005
    • LLC "Biomed"
  • Yaroslavl, Russian Federation, 150003
    • LLC "Center for Medical Advice and Research-PRACTICE"
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology
  • Niska Banja, Serbia, 18205
    • Institute for Treatment and Rehabilitation Niska Banja
  • Novi Sad, Serbia, 21000
    • Special Hospital for Rheumatic Diseases Novi Sad
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0002
      • Jakaranda Hospital
    • Pretoria, Gauteng, South Africa, 0002
      • Emmed Research
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7405
      • Arthritis Clinical Research Trials
    • Cape Town, Western CAPE, South Africa, 7500
      • Panorama Medical Centre
    • Stellenbosch, Western CAPE, South Africa, 7600
      • Winelands Medical Research Centre
• Ukraine
  • Kharkiv, Ukraine, 61058
    • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna likarnia
  • Kyiv, Ukraine, 02081
    • Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu " Instytut revmatolohii "
  • Kyiv, Ukraine, 03680
    • Derzhavna ustanova Natsionalnyi naukovyi tsentr Instytut kardiolohii imeni akademika M.D. Strazheska
  • M. Ivano-Frankivsk, Ukraine, 76018
    • Komunalne Nekomertsiine Pidpryiemstvo "Tsentralna Miska Klinichna Likarnia
  • Odesa, Ukraine, 65025
    • Komunalne nekomertsiine pidpryiemstvo "Odeska oblasna klinichna likarnia"
  • Odesa, Ukraine, 65026
    • Bahatoprofilnyi medychnyi tsentr Odeskoho natsionalnoho medychnoho universytetu
  • Vinnytsia, Ukraine, 21028
    • Komunalne nekomertsiine pidpryiemstvo "Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
  • Zhytomyr, Ukraine, 10002
    • Komunalne pidpryiemstvo "Likarnia No 1" Zhytomyrskoi miskoi rady
• United States
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Graves Gilbert Clinic
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • Texas
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Rheumatology and Pulmonary Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of RA based on 2010 ACR/EULAR for RA for at least a 4 month duration.
• Moderately to severely active RA based on local standard of care.

Exclusion Criteria:

-Evidence of untreated or inadequately treated latent or active TB.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm 1; Subcutaneous (SC) injection given every other week	Drug: PF-06410293; SC injection; Drug: adalimumab; SC injection; Other Names: Humira ®
Active Comparator: Treatment Arm 2; SC injection given every other week	Drug: adalimumab; SC injection; Other Names: Humira ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Reach Cmax (Tmax) of Adalimumab	Tmax is the time taken (in hours) to reach the maximum serum drug concentration.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Week 10, 16, 22, 24, 26, 28, 30, 32

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Anti-Inflammatory Agents; Antirheumatic Agents; Tumor Necrosis Factor Inhibitors; Adalimumab
• Other Study ID Numbers: B5381012 (Other Identifier: Alias Study Number); 2019-000284-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No