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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PF-06410293

adalimumab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Graves Gilbert Clinic
Altoona Center for Clinical Research
Metroplex Clinical Research Center
Rheumatology and Pulmonary Clinic
University Clinical Center of the Republic of Srpska
Health Center Gradiska
Clinical Center University of Sarajevo
General Hospital Prim. Dr.Abdulah Nakas
UMHAT "Dr Georgi Stranski" EAD
DCC Sveti Georgi
Unimed Medical Centre
IMEDICA s.r.o.
Lekarna Na Lidicke
Lekarna Biovita
X-Medica, s.r.o.
Revmacentrum MUDr. Mostera, s.r.o.
L.K.N. Arthrocentrum, s.r.o.
Plicni ambulance
Chirurgie Sibenik
CTCenter MaVe s.r.o
Lekarna u Pottingea
Lekarna Vesalion
CCR Czech a.s.
Lekarna BENU
Revmatologicky ustav
Fakultni Nemocnice v Motole
Lekarna Pod Platany
CCR Prague s.r.o.
Diagnostické centrum Olšanská s.r.o.
Lekarna Hradebni s.r.o.
MEDICAL PLUS s.r.o.
Radiodiagnosticka ordinace a pracoviste
Hospital of Lithuanian University of Health Sciences, Kauno klinikos
Klaipeda University Hospital
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
NZOZ Osteo-Medic s.c. A.Racewicz, J. Supronik
Małopolskie Badania Kliniczne Sp. z o. o. Sp. k.
Pratia MCM Krakow
Zespol Poradni Specjalistycznych REUMED
NZOZ Lecznica MAK-MED s.c.
Twoja Przychodnia Centrum Medyczne Nowa Sol
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Nasz Lekarz Przychodnie Medyczne
Rheuma Medicus Zaklad Opieki Zdrowotnej
Limited Liability Company "Clinic on Maroseyka"
Limited Liability Company Consultative and Diagnostic Rheumatological Center "Healthy Joints"
FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
GBUZ "Orenburg Regional Clinical Hospital"
SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
SBI of the Ryazan Region "Regional Clinical Cardiology dispensary"
SBI of Ryazan Region "Regional Clinical Hospital"
Smolensk Regional Clinical Hospital
FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
LLC "BioMed"
LLC "Center for Medical Advice and Research-PRACTICE"
Institute of Rheumatology
Institute for Treatment and Rehabilitation Niska Banja
Special Hospital for Rheumatic Diseases Novi Sad
Emmed Research
Jakaranda Hospital
Arthritis Clinical Research Trials
Panorama Medical Centre
Winelands Medical Research Centre
Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna likarnia
Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu " Instytut revmatolohii "
Derzhavna ustanova Natsionalnyi naukovyi tsentr Instytut kardiolohii imeni akademika M.D. Strazheska
Komunalne Nekomertsiine Pidpryiemstvo "Tsentralna Miska Klinichna Likarnia
Komunalne nekomertsiine pidpryiemstvo "Odeska oblasna klinichna likarnia"
Bahatoprofilnyi medychnyi tsentr Odeskoho natsionalnoho medychnoho universytetu
Komunalne nekomertsiine pidpryiemstvo "Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
Komunalne pidpryiemstvo "Likarnia No 1" Zhytomyrskoi miskoi rady

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm 1

Treatment Arm 2

Arm Description

Subcutaneous (SC) injection given every other week

SC injection given every other week

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Time to Reach Cmax (Tmax) of Adalimumab

Tmax is the time taken (in hours) to reach the maximum serum drug concentration.

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.

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 Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab

Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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, 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, 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, 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.

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.

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.

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.

Full Information

NCT ID

NCT04230213

First Posted

January 14, 2020

Last Updated

July 29, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04230213

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

January 13, 2020 (Actual)

Primary Completion Date

June 22, 2021 (Actual)

Study Completion Date

June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

455 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm 1

Arm Type

Experimental

Arm Description

Subcutaneous (SC) injection given every other week

Arm Title

Treatment Arm 2

Arm Type

Active Comparator

Arm Description

SC injection given every other week

Intervention Type

Drug

Intervention Name(s)

PF-06410293

Intervention Description

SC injection

Intervention Type

Drug

Intervention Name(s)

adalimumab

Other Intervention Name(s)

Humira ®

Intervention Description

SC injection

Primary Outcome Measure Information:

Title

Maximum Observed Serum Concentration (Cmax) of Adalimumab

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)

Title

Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab

Description

Time Frame

Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)

Secondary Outcome Measure Information:

Title

Time to Reach Cmax (Tmax) of Adalimumab

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)

Title

Average Serum Concentration (Cav) of Adalimumab

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)

Title

Apparent Clearance (CL/F) of Serum Adalimumab

Description

Time Frame

Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)

Title

Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab

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

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1

Description

Time Frame

Day 1 up to maximum of 10 Weeks

Title

Number of Participants With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond

Description

Time Frame

Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)

Title

Number of Participants With Grade 3 or Higher TEAEs: TP1

Description

Time Frame

Day 1 up to maximum of 10 Weeks

Title

Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond

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)

Title

Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP1

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

Title

Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP2 and Beyond

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)

Title

Number of Participants With TEAEs of Special Interest: TP2 and Beyond

Description

Time Frame

Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)

Title

Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1

Description

Time Frame

TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32

Title

Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1

Description

Time Frame

TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32

Title

Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP1

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

Title

Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond

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)

Title

Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP1

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

Title

Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP2 and Beyond

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)

Title

Number of Participants With Laboratory Abnormalities: TP1

Description

Time Frame

Day 1 up to maximum of 10 Weeks

Title

Number of Participants With Laboratory Abnormalities: TP2 and Beyond

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)

Title

Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond

Description

Time Frame

Post randomization up to end of study treatment (maximum of 22 weeks)

Title

Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond

Description

Time Frame

Post randomization up to end of study treatment (maximum of 22 weeks)

Title

Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond

Description

Time Frame

Post randomization up to end of study treatment (maximum of 22 weeks)

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)

Description

Time Frame

Baseline and Week 32 (end of treatment [EOT]/early termination [ET])

Title

Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)

Description

Time Frame

Baseline and Week 32 (EOT/ET)

Title

Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET)

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)

Title

Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET)

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)

Title

Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive

Description

Time Frame

Week 10, 16, 22, 24, 26, 28, 32

Title

Mean ADA Titers

Description

Time Frame

Week 10, 16, 22, 24, 26, 28, 30, 32

Title

Mean NAb Titers

Description

Time Frame

Week 10, 16, 22, 24, 26, 28, 30, 32

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Graves Gilbert Clinic

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Rheumatology and Pulmonary Clinic

City

Beckley

State/Province

West Virginia

ZIP/Postal Code

25801

Country

United States

Facility Name

University Clinical Center of the Republic of Srpska

City

Banja Luka

ZIP/Postal Code

78000

Country

Bosnia and Herzegovina

Facility Name

Health Center Gradiska

City

Gradiska

ZIP/Postal Code

78400

Country

Bosnia and Herzegovina

Facility Name

Clinical Center University of Sarajevo

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

General Hospital Prim. Dr.Abdulah Nakas

City

Sarajevo

ZIP/Postal Code

71000

Country

Bosnia and Herzegovina

Facility Name

UMHAT "Dr Georgi Stranski" EAD

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

DCC Sveti Georgi

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Unimed Medical Centre

City

Plovdiv

ZIP/Postal Code

4023

Country

Bulgaria

Facility Name

IMEDICA s.r.o.

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Lekarna Na Lidicke

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Lekarna Biovita

City

Brno

ZIP/Postal Code

60200

Country

Czechia

Facility Name

X-Medica, s.r.o.

City

Brno

ZIP/Postal Code

613 00

Country

Czechia

Facility Name

Revmacentrum MUDr. Mostera, s.r.o.

City

Brno

ZIP/Postal Code

615 00

Country

Czechia

Facility Name

L.K.N. Arthrocentrum, s.r.o.

City

Hlucin

ZIP/Postal Code

748 01

Country

Czechia

Facility Name

Plicni ambulance

City

Hlucin

ZIP/Postal Code

748 01

Country

Czechia

Facility Name

Chirurgie Sibenik

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

CTCenter MaVe s.r.o

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Lekarna u Pottingea

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Lekarna Vesalion

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

CCR Czech a.s.

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Lekarna BENU

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

12850

Country

Czechia

Facility Name

Fakultni Nemocnice v Motole

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Lekarna Pod Platany

City

Praha

ZIP/Postal Code

101 00

Country

Czechia

Facility Name

CCR Prague s.r.o.

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Diagnostické centrum Olšanská s.r.o.

City

Praha

ZIP/Postal Code

13000

Country

Czechia

Facility Name

Lekarna Hradebni s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

MEDICAL PLUS s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

Radiodiagnosticka ordinace a pracoviste

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

Hospital of Lithuanian University of Health Sciences, Kauno klinikos

City

Kaunas

ZIP/Postal Code

LT-50161

Country

Lithuania

Facility Name

Klaipeda University Hospital

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

City

Bialystok

ZIP/Postal Code

15-099

Country

Poland

Facility Name

NZOZ Osteo-Medic s.c. A.Racewicz, J. Supronik

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Małopolskie Badania Kliniczne Sp. z o. o. Sp. k.

City

Krakow

ZIP/Postal Code

30-002

Country

Poland

Facility Name

Pratia MCM Krakow

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Zespol Poradni Specjalistycznych REUMED

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED s.c.

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Twoja Przychodnia Centrum Medyczne Nowa Sol

City

Nowa Sol

ZIP/Postal Code

67-100

Country

Poland

Facility Name

Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Nasz Lekarz Przychodnie Medyczne

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Rheuma Medicus Zaklad Opieki Zdrowotnej

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

Limited Liability Company "Clinic on Maroseyka"

City

Moscow

ZIP/Postal Code

101000

Country

Russian Federation

Facility Name

Limited Liability Company Consultative and Diagnostic Rheumatological Center "Healthy Joints"

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation

City

Orenburg

ZIP/Postal Code

460000

Country

Russian Federation

Facility Name

GBUZ "Orenburg Regional Clinical Hospital"

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"

City

Petrozavodsk

ZIP/Postal Code

185910

Country

Russian Federation

Facility Name

FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

SBI of the Ryazan Region "Regional Clinical Cardiology dispensary"

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

SBI of Ryazan Region "Regional Clinical Hospital"

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

Smolensk Regional Clinical Hospital

City

Smolensk

ZIP/Postal Code

214018

Country

Russian Federation

Facility Name

FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

LLC "BioMed"

City

Vladimir

ZIP/Postal Code

600005

Country

Russian Federation

Facility Name

LLC "Center for Medical Advice and Research-PRACTICE"

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Institute of Rheumatology

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Institute for Treatment and Rehabilitation Niska Banja

City

Niska Banja

ZIP/Postal Code

18205

Country

Serbia

Facility Name

Special Hospital for Rheumatic Diseases Novi Sad

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Emmed Research

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Jakaranda Hospital

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Arthritis Clinical Research Trials

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Panorama Medical Centre

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Winelands Medical Research Centre

City

Stellenbosch

State/Province

Western CAPE

ZIP/Postal Code

7600

Country

South Africa

Facility Name

Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna likarnia

City

Kharkiv

ZIP/Postal Code

61058

Country

Ukraine

Facility Name

Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu " Instytut revmatolohii "

City

Kyiv

ZIP/Postal Code

02081

Country

Ukraine

Facility Name

Derzhavna ustanova Natsionalnyi naukovyi tsentr Instytut kardiolohii imeni akademika M.D. Strazheska

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Komunalne Nekomertsiine Pidpryiemstvo "Tsentralna Miska Klinichna Likarnia

City

M. Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Komunalne nekomertsiine pidpryiemstvo "Odeska oblasna klinichna likarnia"

City

Odesa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Bahatoprofilnyi medychnyi tsentr Odeskoho natsionalnoho medychnoho universytetu

City

Odesa

ZIP/Postal Code

65026

Country

Ukraine

Facility Name

Komunalne nekomertsiine pidpryiemstvo "Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova

City

Vinnytsia

ZIP/Postal Code

21028

Country

Ukraine

Facility Name

Komunalne pidpryiemstvo "Likarnia No 1" Zhytomyrskoi miskoi rady

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=B5381012

Description

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

Learn more about this trial

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

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