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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04230213
• Collaborator: (none)
• Enrollment: 455
• Locations: 72
• Arms: 2
• Actual Duration (Months): 17.3
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: PF-06410293; Drug: adalimumab	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 455 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 13, 2020
• Actual Primary Completion Date: Jun 22, 2021
• Actual Study Completion Date: Jun 22, 2021

Arms and Interventions

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 ®

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Serum Concentration (Cmax) of Adalimumab [Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)]

   Cmax refers to maximum observed serum concentration of drug. The geometric coefficient of variation is expressed in percentage.

2. Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab [Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)]

   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

1. Time to Reach Cmax (Tmax) of Adalimumab [Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)]

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

2. Average Serum Concentration (Cav) of Adalimumab [Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)]

   Cav was defined as average serum concentration over the dosing interval. The geometric coefficient of variation is expressed in percentage.

3. Apparent Clearance (CL/F) of Serum Adalimumab [Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)]

   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.

4. Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab [Pre-dose on Day 1, 71,113, 155, 169, 183, 197 and 211]

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

5. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1 [Day 1 up to maximum of 10 Weeks]

   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.

6. Number of Participants With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond [Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)]

   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.

7. Number of Participants With Grade 3 or Higher TEAEs: TP1 [Day 1 up to maximum of 10 Weeks]

   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.

8. Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond [Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)]

   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.

9. Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP1 [Day 1 up to maximum of 10 Weeks]

   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.

10. Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP2 and Beyond [Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)]

    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.

11. Number of Participants With TEAEs of Special Interest: TP2 and Beyond [Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)]

    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.

12. Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1 [TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32]

    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.

13. Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1 [TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32]

    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.

14. Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP1 [Day 1 up to maximum of 10 Weeks]

    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.

15. Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond [Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)]

    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.

16. Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP1 [Day 1 up to maximum of 10 Weeks]

    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.

17. Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP2 and Beyond [Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)]

    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.

18. Number of Participants With Laboratory Abnormalities: TP1 [Day 1 up to maximum of 10 Weeks]

    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.

19. Number of Participants With Laboratory Abnormalities: TP2 and Beyond [Post randomization up to end of study treatment (maximum of 22 weeks)]

    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.

20. Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond [Post randomization up to end of study treatment (maximum of 22 weeks)]

    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.

21. Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond [Post randomization up to end of study treatment (maximum of 22 weeks)]

    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.

22. Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond [Post randomization up to end of study treatment (maximum of 22 weeks)]

    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.

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

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

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

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

27. Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive [Week 10, 16, 22, 24, 26, 28, 32]

    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.

28. Mean ADA Titers [Week 10, 16, 22, 24, 26, 28, 30, 32]

    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.

29. Mean NAb Titers [Week 10, 16, 22, 24, 26, 28, 30, 32]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

• Study Protocol - May 19, 2020
• Statistical Analysis Plan - Jul 13, 2021

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04230213
• Other Study ID Numbers: B5381012; 2019-000284-24; B5381012
• First Posted: Jan 18, 2020
• Last Update Posted: Aug 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Adalimumab

Study Results

Participant Flow

Pre-assignment Detail	A total of 455 participants were enrolled in the study of which 10 participants were excluded from all the data analyses due to violation of Good Clinical Practice (GCP) principles. These 10 participants were not included in any section of results.

Arm/Group Title	Humira (Adalimumab)	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 milligrams (mg) once every 2 weeks subcutaneously for 10 weeks during Treatment Period 1 (TP1).	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Period Title: TP1: Week 0 (Day 1) to Week 10
STARTED	445	0	0
COMPLETED	427	0	0
NOT COMPLETED	18	0	0
Period Title: TP1: Week 0 (Day 1) to Week 10
STARTED	0	213	214
COMPLETED	0	211	211
NOT COMPLETED	0	2	3
Period Title: TP1: Week 0 (Day 1) to Week 10
STARTED	0	211	211
COMPLETED	0	210	204
NOT COMPLETED	0	1	7
Period Title: TP1: Week 0 (Day 1) to Week 10
STARTED	0	210	204
COMPLETED	0	202	196
NOT COMPLETED	0	8	8
Period Title: TP1: Week 0 (Day 1) to Week 10
STARTED	0	202	196
COMPLETED	0	201	194
NOT COMPLETED	0	1	2

Baseline Characteristics

Arm/Group Title	Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1. After completing TP1, participants were randomized to Switching Arm: Humira and PF-06410293 (Adalimumab) and Non-switching Arm: Humira (Adalimumab). Participants randomized to Switching Arm: Humira and PF-06410293 (Adalimumab) received PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during TP2. TP2 was followed by TP3. In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by TP4. In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants randomized to Non-switching Arm: Humira (Adalimumab) after completing TP1 continued treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Overall Participants	445
Age (Years) [Mean (Standard Deviation) ]
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 (Count of Participants)
Female	368 82.7%
Male	77 17.3%
Female	175 39.3%
Male	38 8.5%
Female	179 40.2%
Male	35 7.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 0.9%
Not Hispanic or Latino	440 98.9%
Unknown or Not Reported	1 0.2%
Hispanic or Latino	2 0.4%
Not Hispanic or Latino	210 47.2%
Unknown or Not Reported	1 0.2%
Hispanic or Latino	1 0.2%
Not Hispanic or Latino	213 47.9%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 0.4%
White	440 98.9%
More than one race	0 0%
Unknown or Not Reported	3 0.7%
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	212 47.6%
More than one race	0 0%
Unknown or Not Reported	1 0.2%
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	210 47.2%
More than one race	2 0.4%
Unknown or Not Reported	2 0.4%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) population included all randomized participants who were dosed to initiate the week 30 steady-state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	194	186
Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter]	9.156 (97)	8.974 (97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Switching Arm: Humira and PF-06410293 (Adalimumab), Non-switching Arm: Humira (Adalimumab)
	Comments
	Type of Statistical Test	Equivalence
	Comments	Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (percentage)
	Estimated Value	102.56
	Confidence Interval	(2-Sided) 90%; 89.78 to 117.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Analysis was performed using analysis of variance (ANOVA) model.

2. Primary Outcome

Title	Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab
Description	Area under the serum concentration curve from time 0 to end of dosing interval (tau), where dosing interval was once every two weeks. The geometric coefficient of variation is expressed in percentage.
Time Frame	Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)

Outcome Measure Data

Analysis Population Description

PK population included all randomized participants who were dosed to initiate the Week 30 steady-state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	189	183
Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter*hour]	2.472 (129)	2.365 (133)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Switching Arm: Humira and PF-06410293 (Adalimumab), Non-switching Arm: Humira (Adalimumab)
	Comments
	Type of Statistical Test	Equivalence
	Comments	Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Geometric mean ratio (Percentage)
	Estimated Value	105.31
	Confidence Interval	(2-Sided) 90%; 89.16 to 124.39
	Parameter Dispersion	Type: Value:
	Estimation Comments	Analysis was performed using ANOVA model.

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

PK population included all randomized participants who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	194	186
Median (Full Range) [Hours]	71.80	72.00

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

PK population included all randomized participants who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	189	183
Geometric Mean (Geometric Coefficient of Variation) [Micrograms per milliliter]	7.357 (130)	7.040 (133)

5. Secondary Outcome

Title	Apparent Clearance (CL/F) of Serum Adalimumab
Description	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by area under the concentration curve from time 0 extrapolated to infinite time (AUCinf). The geometric coefficient of variation is expressed in percentage.
Time Frame	Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)

Outcome Measure Data

Analysis Population Description

PK population included all randomized participants who were dosed to initiate the Week 30 steady state PK profile and remained on background methotrexate with no major protocol deviations influencing the PK assessment. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Since time points for analysis for this outcome measure were falling in TP4, hence only switching and non-switching arms data were reported.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	189	183
Geometric Mean (Geometric Coefficient of Variation) [Milliliter per hour]	16.19 (129)	16.91 (133)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Data for Days 1 and 71 were identified retrospectively for participants in the safety randomized population, hence included in the switching and non-switching reporting groups. Here, "Number Analyzed" signifies participants evaluable for each specified category.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
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)

7. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1
Description	An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAE for TP1 was defined as any AE that occurred after the beginning of study treatment in TP1 and before the first dose of study treatment administration after randomization in TP2. AEs included both serious and all non-serious AEs.
Time Frame	Day 1 up to maximum of 10 Weeks

Outcome Measure Data

Analysis Population Description

Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.

Arm/Group Title	Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Measure Participants	445
TEAEs	107 24%
Serious TEAEs	13 2.9%
Treatment related TEAEs	31 7%

8. Secondary Outcome

Title	Number of Participants With TEAEs, Serious TEAEs and Treatment Related 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. 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)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
TEAEs	82 18.4%	62 NaN
Serious TEAEs	3 0.7%	8 NaN
Treatment related TEAEs	19 4.3%	10 NaN

9. Secondary Outcome

Title	Number of Participants With Grade 3 or Higher 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. 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

Outcome Measure Data

Analysis Population Description

Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.

Arm/Group Title	Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Measure Participants	445
Count of Participants [Participants]	14 3.1%

10. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
Count of Participants [Participants]	5 1.1%	8 NaN

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.

Arm/Group Title	Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Measure Participants	445
Discontinued from treatment due to TEAEs	3 0.7%
Discontinued from study due to TEAE	12 2.7%

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
Discontinued from treatment due to TEAEs	0 0%	3 NaN
Discontinued from study due to TEAEs	8 1.8%	9 NaN

13. Secondary Outcome

Title	Number of Participants With TEAEs of Special Interest: TP2 and Beyond
Description	AEs of special interest (AESI) included: hypersensitivity events (anaphylactic reaction, hypersensitivity, angioedema, delayed immune responses and injection site reactions [ISRs]); blood and lymphatic system events (white blood cell disorders and anemias nonhemolytic and marrow depression); cardiovascular events (cardiac failure, hypertension and myocardial infarction); demyelinating conditions, gastric/hepatic events (gastrointestinal perforation, ulceration, hemorrhage or obstruction and hepatic disorders); infections and infestations (including TB and other opportunistic infections); malignancies (neoplasms benign, malignant and unspecified [including cysts and polyps]) and lupus like syndrome. TEAE was defined as any AE that occurred after the first dose of study treatment administered after randomization in TP2. Number of participants with any AESI were presented in this outcome measure.
Time Frame	Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
Count of Participants [Participants]	58 13%	47 NaN

14. Secondary Outcome

Title	Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1
Description	In this outcome, participants who were antidrug antibody (ADA) positive during TP1 were assessed in TP2 and beyond per visit for their ADA status at the time of start of their potential immunogenic AEs including ISRs, medically evaluated board standard MedDRA query (SMQ) of potential hypersensitivity (anaphylactic reactions, hypersensitivity and angioedema), medically evaluated AEs meeting Sampson criteria, cytokine storm and delayed immune responses (DIR). ADA positive was defined as ADA titer >=1.88.
Time Frame	TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10.Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specific rows.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	55	59
Week 16: ISR	0 0%	1 NaN
Week 16: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 16: AEs belonging to SMQ Group	0 0%	0 NaN
Week 22: ISR	0 0%	1 NaN
Week 22: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 22: AEs belonging to SMQ Group	0 0%	0 NaN
Week 24: ISR	0 0%	1 NaN
Week 24: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 24: AEs belonging to SMQ Group	0 0%	1 NaN
Week 26: ISR	1 0.2%	1 NaN
Week 26: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 26: AEs belonging to SMQ Group	0 0%	0 NaN
Week 28: ISR	0 0%	1 NaN
Week 28: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 28: AEs belonging to SMQ Group	0 0%	0 NaN
Week 30: ISR	0 0%	1 NaN
Week 30: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 30: AEs belonging to SMQ Group	1 0.2%	0 NaN
Week 32: ISR	0 0%	0 NaN
Week 32: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 32: AEs belonging to SMQ Group	0 0%	0 NaN

15. Secondary Outcome

Title	Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1
Description	In this outcome, participants who were ADA negative during TP1 were assessed in TP2 and beyond per visit for their ADA status at the time of start of their potential immunogenic AEs including ISRs, medically evaluated board SMQ of potential hypersensitivity (anaphylactic reactions, hypersensitivity and angioedema), medically evaluated AEs meeting Sampson criteria, cytokine storm and DIR. ADA negative was defined as ADA titer <1.88.
Time Frame	TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10.Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for specific rows.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	156	155
Week 16: ISR	4 0.9%	2 NaN
Week 16: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 16: AEs belonging to SMQ Group	0 0%	0 NaN
Week 22: ISR	1 0.2%	1 NaN
Week 22: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 22: AEs belonging to SMQ Group	0 0%	0 NaN
Week 24: ISR	0 0%	2 NaN
Week 24: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 24: AEs belonging to SMQ Group	0 0%	0 NaN
Week 26: ISR	0 0%	2 NaN
Week 26: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 26: AEs belonging to SMQ Group	0 0%	0 NaN
Week 28: ISR	0 0%	1 NaN
Week 28: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 28: AEs belonging to SMQ Group	0 0%	0 NaN
Week 30: ISR	0 0%	1 NaN
Week 30: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 30: AEs belonging to SMQ Group	0 0%	0 NaN
Week 32: ISR	0 0%	1 NaN
Week 32: Medically evaluated Sampson criteria met	0 0%	0 NaN
Week 32: AEs belonging to SMQ Group	0 0%	0 NaN

16. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.

Arm/Group Title	Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Measure Participants	445
TEAE	10 2.2%
Serious TEAE	6 1.3%

17. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
TEAE	20 4.5%	16 NaN
Serious TEAE	1 0.2%	3 NaN

18. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1.

Arm/Group Title	Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Measure Participants	445
Discontinued from treatment due to TEAEs	0 0%
Discontinued from study due to TEAE	6 1.3%

19. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
Discontinued from treatment due to TEAEs	0 0%	0 NaN
Discontinued from study due to TEAE	3 0.7%	4 NaN

20. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities: TP1
Description	Blood samples were collected for the analysis of following laboratory parameters: hematology parameters (hemoglobin, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular hemoglobin concentration platelet count, leukocytes, lymphocytes, neutrophils, eosinophils, monocytes); clinical chemistry parameters (bilirubin, alanine aminotransferase [ALT], blood urea nitrogen [BUN], creatinine, potassium, bicarbonate); urine parameters: urine protein, urine hemoglobin, nitrite, leukocyte esterase and bacteria. Number of participants with any laboratory abnormalities is presented.
Time Frame	Day 1 up to maximum of 10 Weeks

Outcome Measure Data

Analysis Population Description

Safety population for TP1 included all participants who were enrolled and received at least one dose of study treatment in TP1. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Arm/Group Title	Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.
Measure Participants	437
Count of Participants [Participants]	134 30.1%

21. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	211	208
Count of Participants [Participants]	71 16%	83 NaN

22. Secondary Outcome

Title	Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond
Description	Blood samples were collected for the analysis of following hematology parameters: anemia, hemoglobin increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Laboratory parameters were graded according to National Cancer Institute-CTC version 4.03 where, Grade 0= within normal limits; Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences and Grade 5: death. Categories with at least 1 non-zero value were reported in this outcome measure.
Time Frame	Post randomization up to end of study treatment (maximum of 22 weeks)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each row.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	209	205
Grade 0: Anemia	198 44.5%	190 NaN
Grade 0: Hemoglobin increased	207 46.5%	201 NaN
Grade 0: Leukocytosis	209 47%	205 NaN
Grade 0: Lymphocyte count decreased	204 45.8%	200 NaN
Grade 0: Lymphocyte count increased	203 45.6%	196 NaN
Grade 0: Neutrophil count decreased	198 44.5%	197 NaN
Grade 0: Platelet count decreased	201 45.2%	200 NaN
Grade 0: White blood cell decreased	202 45.4%	199 NaN
Grade 1: Anemia	5 1.1%	7 NaN
Grade 1: Hemoglobin increased	2 0.4%	3 NaN
Grade 1: Lymphocyte count decreased	4 0.9%	3 NaN
Grade 1: Neutrophil count decreased	4 0.9%	3 NaN
Grade 1: Platelet count decreased	6 1.3%	4 NaN
Grade 1: White blood cell decreased	6 1.3%	6 NaN
Grade 2: Anemia	6 1.3%	6 NaN
Grade 2: Hemoglobin increased	0 0%	1 NaN
Grade 2: Lymphocyte count decreased	1 0.2%	2 NaN
Grade 2: Lymphocyte count increased	6 1.3%	9 NaN
Grade 2: Neutrophil count decreased	7 1.6%	4 NaN
Grade 2: White blood cell decreased	1 0.2%	0 NaN
Grade 3: Anemia	0 0%	2 NaN

23. Secondary Outcome

Title	Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond
Description	Blood samples were collected for analysis of clinical chemistry parameters: ALT increased, alkaline phosphatase increased (ALP), aspartate aminotransferase increased (AST), blood bilirubin increased, creatinine increased, hypercalcemia, hyperkalemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hyponatremia. Laboratory parameters were graded according to NCI-CTC version 4.03 where, grade 0= within normal limits; Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences and Grade 5: death. Categories with at least 1 non-zero value were reported.
Time Frame	Post randomization up to end of study treatment (maximum of 22 weeks)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Here, "Number Analyzed" signifies participants evaluable for each row.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	212	208
Grade 0: ALT increased	169 38%	174 NaN
Grade 0: ALP increased	202 45.4%	196 NaN
Grade 0: AST increased	195 43.8%	198 NaN
Grade 0: Blood bilirubin increased	205 46.1%	204 NaN
Grade 0: Creatinine increased	171 38.4%	151 NaN
Grade 0: Hypercalcemia	211 47.4%	207 NaN
Grade 0: Hyperkalemia	208 46.7%	202 NaN
Grade 0: Hypernatremia	210 47.2%	207 NaN
Grade 0: Hypoalbuminemia	212 47.6%	208 NaN
Grade 0: Hypocalcemia	201 45.2%	202 NaN
Grade 0: Hypokalemia	210 47.2%	207 NaN
Grade 0: Hyponatremia	211 47.4%	207 NaN
Grade 1: ALT increased	40 9%	33 NaN
Grade 1: ALP increased	9 2%	12 NaN
Grade 1: AST increased	16 3.6%	10 NaN
Grade 1: Blood bilirubin increased	5 1.1%	3 NaN
Grade 1: Creatinine increased	39 8.8%	52 NaN
Grade 1: Hypercalcemia	0 0%	1 NaN
Grade 1: Hyperkalemia	4 0.9%	6 NaN
Grade 1: Hypernatremia	2 0.4%	1 NaN
Grade 1: Hypocalcemia	10 2.2%	6 NaN
Grade 1: Hyponatremia	1 0.2%	1 NaN
Grade 2: ALT increased	2 0.4%	1 NaN
Grade 2: Blood bilirubin increased	1 0.2%	1 NaN
Grade 2: Creatinine increased	1 0.2%	5 NaN
Grade 2: Hypokalemia	2 0.4%	1 NaN

24. Secondary Outcome

Title	Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond
Description	In this outcome measure, liver function laboratory parameters, which included: normal bilirubin and AST/ALT, Temple's Corollary (AST/ALT [more than or equal to] >=3*upper limit normal [ULN] and normal bilirubin), Gilbert's Syndrome or cholestasis (normal AST/ALT and bilirubin >=2*ULN) and Potential Hy's Law Cases (AST/ALT >=3*ULN and Bilirubin>=2*ULN) according to eDISH criteria, were reported.
Time Frame	Post randomization up to end of study treatment (maximum of 22 weeks)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of dose of investigational product following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	211	208
Normal Bilirubin and AST/ALT	208 46.7%	207 NaN
Temple's Corollary (AST/ALT >=3* upper limit normal [ULN] and Normal Bilirubin)	2 0.4%	1 NaN
Gilbert's Syndrome or Cholestasis (Normal AST/ALT and Bilirubin >=2*ULN)	1 0.2%	0 NaN
Potential Hy's Law Cases (AST/ALT >=3*ULN and Bilirubin>=2*ULN)	0 0%	0 NaN

25. Secondary Outcome

Title	Baseline, Absolute Week 32 Values for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Change From Baseline in SBP, DBP at Week 32 (EOT/ ET)
Description	SBP and DBP were measured in a supine position using an automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
Time Frame	Baseline and Week 32 (end of treatment [EOT]/early termination [ET])

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	212	209
SBP: Baseline	125.7 (12.72)	125.9 (11.49)
SBP: Absolute value at Week 32 (EOT/ET)	126.0 (11.20)	126.2 (12.69)
SBP: Change at Week 32 (EOT/ET)	0.3 (11.49)	0.4 (11.28)
DBP: Baseline	78.1 (8.31)	77.7 (7.60)
DBP: Absolute value at Week 32 (EOT/ET)	78.6 (7.77)	77.5 (7.54)
DBP: Change at Week 32 (EOT/ET)	0.5 (8.04)	-0.2 (8.32)

26. Secondary Outcome

Title	Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)
Description	Pulse rate was measured in a supine position using an automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without any distractions. Baseline value was defined as the most recent measurement prior to the first dose of study treatment after randomization in TP2.
Time Frame	Baseline and Week 32 (EOT/ET)

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	212	209
Baseline	73.6 (8.55)	73.2 (8.42)
Absolute value at Week 32 (EOT/ET)	73.6 (7.94)	73.1 (7.98)
Change at Week 32 (EOT/ET)	0.1 (8.55)	-0.2 (7.68)

27. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	212	209
Baseline	36.5 (0.27)	36.5 (0.27)
Absolute value at Week 32 (EOT/ET)	36.4 (0.26)	36.4 (0.20)
Change at Week 32 (EOT/ET)	-0.0 (0.28)	-0.0 (0.27)

28. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of study treatment following the randomization at Study Week 10. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	212	209
Baseline	16.6 (1.75)	16.6 (2.10)
Absolute value at Week 32 (EOT/ET)	16.5 (1.81)	16.6 (2.00)
Change at Week 32 (EOT/ET)	-0.1 (1.36)	-0.0 (1.52)

29. Secondary Outcome

Title	Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive
Description	Serum samples were analyzed using a validated electrochemoluminescent (ECL) immunoassay for ADA assessment. Samples positive for ADA were further tested for neutralizing activity using a validated cell based NAb assay. ADA positive was defined as ADA titer >=1.88 while NAb positive was defined as NAb titer >=0.70.
Time Frame	Week 10, 16, 22, 24, 26, 28, 32

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10. For ADA: "Number Analyzed" = all participants assessed for ADA measurement at specific time points. For Nab: "Number Analyzed" = all participants with ADA positive results assessed for Nab measurement at specific time points.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
Week 10: ADA positive	55 12.4%	59 NaN
Week 10: NAb positive	22 4.9%	19 NaN
Week 16: ADA positive	88 19.8%	97 NaN
Week 16: NAb positive	22 4.9%	21 NaN
Week 22: ADA positive	96 21.6%	106 NaN
Week 22: NAb positive	24 5.4%	20 NaN
Week 24: ADA positive	102 22.9%	100 NaN
Week 24: NAb positive	19 4.3%	20 NaN
Week 26: ADA positive	101 22.7%	105 NaN
Week 26: NAb positive	21 4.7%	15 NaN
Week 28: ADA positive	102 22.9%	105 NaN
Week 28: NAb positive	18 4%	16 NaN
Week 30: ADA positive	103 23.1%	109 NaN
Week 30: NAb positive	17 3.8%	19 NaN
Week 32: ADA positive	100 22.5%	104 NaN
Week 32: NAb positive	18 4%	18 NaN

30. Secondary Outcome

Title	Mean ADA Titers
Description	Serum samples were analyzed using a validated ECL immunoassay for ADA assessment. Endpoint titer was defined as log10 of the reciprocal of the ADA serum dilution at which the sample response was equal to the cut-point of the assay.
Time Frame	Week 10, 16, 22, 24, 26, 28, 30, 32

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10. Here, 'Number Analyzed' signifies participants evaluable with ADA non-missing values at specific time points.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
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)

31. Secondary Outcome

Title	Mean NAb Titers
Description	Serum samples were analyzed using a validated ECL immunoassay for ADA assessment. Endpoint titer was defined as log10 of the reciprocal of the NAb serum dilution at which the sample response was equal to the cut-point of the assay.
Time Frame	Week 10, 16, 22, 24, 26, 28, 30, 32

Outcome Measure Data

Analysis Population Description

Safety randomized population included all participants who were randomized and received at least one dose of investigational product following the randomization at Study Week 10. Here, 'Number Analyzed' signifies participants evaluable with NAb non-missing values at specific time points.

Arm/Group Title	Switching Arm: Humira and PF-06410293 (Adalimumab)	Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.	Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
Measure Participants	213	214
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)

Adverse Events

Time Frame	TP1: Day 1 up to maximum of 10 Weeks TP2 and beyond: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
Adverse Event Reporting Description	Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. As planned, AE were analyzed for TP1 using the Safety-TP1 population for the Humira arm. AE analyses for TP2 and beyond were performed using Safety-randomized population for switching arm and non-switching arm.
Arm/Group Title	Humira (Adalimumab)		Switching Arm: Humira and PF-06410293 (Adalimumab)		Non-switching Arm: Humira (Adalimumab)
Arm/Group Description	All participants received Humira 40 mg once every 2 weeks subcutaneously for 10 weeks during TP1.		Participants after completing TP1, were randomized to receive PF-06410293 40 mg once every 2 weeks subcutaneously for 6 weeks during Treatment Period 2 (TP2). TP2 was followed by Treatment Period 3 (TP3). In TP3 participants received Humira 40 mg once every 2 weeks subcutaneously for another 6 weeks. TP3 was followed by Treatment Period 4 (TP4). In TP4 participants received PF-06410293 40 mg once every 2 weeks subcutaneously for next 10 weeks. Participants were followed for 4 weeks post last dose.		Participants after completing TP1, were randomized to continue treatment with Humira 40 mg once every 2 weeks subcutaneously for 22 weeks (during TP2 to TP4). Participants were followed for 4 weeks post last dose.
All Cause Mortality
	Humira (Adalimumab)		Switching Arm: Humira and PF-06410293 (Adalimumab)		Non-switching Arm: Humira (Adalimumab)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/445 (0%)		0/213 (0%)		0/214 (0%)
Serious Adverse Events
	Humira (Adalimumab)		Switching Arm: Humira and PF-06410293 (Adalimumab)		Non-switching Arm: Humira (Adalimumab)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/445 (2.9%)		3/213 (1.4%)		8/214 (3.7%)
Blood and lymphatic system disorders
Blood loss anaemia	0/445 (0%)		0/213 (0%)		1/214 (0.5%)
Eye disorders
Keratitis	0/445 (0%)		1/213 (0.5%)		0/214 (0%)
Hepatobiliary disorders
Cholelithiasis	1/445 (0.2%)		0/213 (0%)		0/214 (0%)
Cholecystitis acute	0/445 (0%)		0/213 (0%)		1/214 (0.5%)
Infections and infestations
COVID-19	5/445 (1.1%)		0/213 (0%)		1/214 (0.5%)
COVID-19 pneumonia	1/445 (0.2%)		1/213 (0.5%)		2/214 (0.9%)
Influenza	1/445 (0.2%)		0/213 (0%)		0/214 (0%)
Lyme disease	2/445 (0.4%)		0/213 (0%)		0/214 (0%)
Pneumonia	1/445 (0.2%)		0/213 (0%)		1/214 (0.5%)
Abscess limb	0/445 (0%)		1/213 (0.5%)		0/214 (0%)
Injury, poisoning and procedural complications
Subdural haemorrhage	0/445 (0%)		0/213 (0%)		1/214 (0.5%)
Musculoskeletal and connective tissue disorders
Back pain	1/445 (0.2%)		0/213 (0%)		0/214 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic	1/445 (0.2%)		0/213 (0%)		0/214 (0%)
Nervous system disorders
Ischaemic stroke	0/445 (0%)		0/213 (0%)		1/214 (0.5%)
Reproductive system and breast disorders
Heavy menstrual bleeding	1/445 (0.2%)		0/213 (0%)		0/214 (0%)
Other (Not Including Serious) Adverse Events
	Humira (Adalimumab)		Switching Arm: Humira and PF-06410293 (Adalimumab)		Non-switching Arm: Humira (Adalimumab)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/445 (6.3%)		46/213 (21.6%)		38/214 (17.8%)
Gastrointestinal disorders
Abdominal pain upper	0/445 (0%)		3/213 (1.4%)		0/214 (0%)
General disorders
Injection site reaction	13/445 (2.9%)		6/213 (2.8%)		4/214 (1.9%)
Swelling	0/445 (0%)		3/213 (1.4%)		1/214 (0.5%)
Infections and infestations
Urinary tract infection	5/445 (1.1%)		4/213 (1.9%)		3/214 (1.4%)
COVID-19	0/445 (0%)		16/213 (7.5%)		9/214 (4.2%)
Nasopharyngitis	0/445 (0%)		0/213 (0%)		7/214 (3.3%)
Upper respiratory tract infection	0/445 (0%)		3/213 (1.4%)		3/214 (1.4%)
Investigations
SARS-CoV-2 test positive	9/445 (2%)		18/213 (8.5%)		14/214 (6.5%)
Alanine aminotransferase increased	0/445 (0%)		3/213 (1.4%)		1/214 (0.5%)
Aspartate aminotransferase increased	0/445 (0%)		3/213 (1.4%)		1/214 (0.5%)
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis	0/445 (0%)		3/213 (1.4%)		1/214 (0.5%)
Nervous system disorders
Headache	0/445 (0%)		4/213 (1.9%)		4/214 (1.9%)
Respiratory, thoracic and mediastinal disorders
Cough	0/445 (0%)		3/213 (1.4%)		1/214 (0.5%)
Skin and subcutaneous tissue disorders
Erythema	10/445 (2.2%)		6/213 (2.8%)		4/214 (1.9%)
Pruritus	7/445 (1.6%)		0/213 (0%)		0/214 (0%)
Rash	0/445 (0%)		3/213 (1.4%)		0/214 (0%)
Vascular disorders
Hypertension	0/445 (0%)		2/213 (0.9%)		5/214 (2.3%)

Limitations/Caveats

In participant flow, there were discontinuations due to AEs, which were captured within different reasons for discontinuations (e.g. other, physician decision etc.) as the study case report form (CRF) page did not include AE as an option for sites to record if the discontinuation was truly due to AE.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.