Clinical trial NCT04230213: A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis
Official title: A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Adalimumab
timeFrame: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
measure: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Adalimumab
timeFrame: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
Secondary outcomes:
measure: Time to Reach Cmax (Tmax) of Adalimumab
timeFrame: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
measure: Average Serum Concentration (Cav) of Adalimumab
timeFrame: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
measure: Apparent Clearance (CL/F) of Serum Adalimumab
timeFrame: Pre-dose, 48, 72, 96, 144, 240 and 336 hours post dose on Day 211 (Week 30)
measure: Pre-dose Serum Concentration During Multiple Dosing (Ctrough) of Adalimumab
timeFrame: Pre-dose on Day 1, 71,113, 155, 169, 183, 197 and 211
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and Treatment Related TEAEs: TP1
timeFrame: Day 1 up to maximum of 10 Weeks
measure: Number of Participants With TEAEs, Serious TEAEs and Treatment Related TEAEs: TP2 and Beyond
timeFrame: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
measure: Number of Participants With Grade 3 or Higher TEAEs: TP1
timeFrame: Day 1 up to maximum of 10 Weeks
measure: Number of Participants With Grade 3 or Higher TEAEs: TP2 and Beyond
timeFrame: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
measure: Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP1
timeFrame: Day 1 up to maximum of 10 Weeks
measure: Number of Participants Who Discontinued Treatment and Study Due to TEAEs: TP2 and Beyond
timeFrame: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
measure: Number of Participants With TEAEs of Special Interest: TP2 and Beyond
timeFrame: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
measure: Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among Anti-drug Antibody (ADA) Positive Participants During TP1
timeFrame: TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32
measure: Number of Participants With Potential Immunogenic AEs to Study Treatment: TP2 and Beyond Among ADA Negative Participants During TP1
timeFrame: TP2 and Beyond: Week 16, 22, 24, 26, 28, 30, 32
measure: Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP1
timeFrame: Day 1 up to maximum of 10 Weeks
measure: Number of Participants With TEAEs and Serious TEAEs Related to COVID-19: TP2 and Beyond
timeFrame: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
measure: Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP1
timeFrame: Day 1 up to maximum of 10 Weeks
measure: Number of Participants Who Discontinued Treatment and Study Due to TEAEs Related to COVID-19: TP2 and Beyond
timeFrame: Post randomization up to maximum of 4 weeks after last dose (maximum of 26 weeks)
measure: Number of Participants With Laboratory Abnormalities: TP1
timeFrame: Day 1 up to maximum of 10 Weeks
measure: Number of Participants With Laboratory Abnormalities: TP2 and Beyond
timeFrame: Post randomization up to end of study treatment (maximum of 22 weeks)
measure: Number of Participants With Hematology Results by Maximum Common Toxicity Criteria (CTC) Grade: TP2 and Beyond
timeFrame: Post randomization up to end of study treatment (maximum of 22 weeks)
measure: Number of Participants With Chemistry Results by Maximum CTC Grade: TP2 and Beyond
timeFrame: Post randomization up to end of study treatment (maximum of 22 weeks)
measure: Number of Participants With Laboratory Results Based on Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) Analysis: TP2 and Beyond
timeFrame: Post randomization up to end of study treatment (maximum of 22 weeks)
measure: 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)
timeFrame: Baseline and Week 32 (end of treatment [EOT]/early termination [ET])
measure: Baseline, Absolute Week 32 Values for Pulse Rate and Change From Baseline in Pulse Rate at Week 32 (EOT/ET)
timeFrame: Baseline and Week 32 (EOT/ET)
measure: Baseline, Absolute Week 32 Values for Temperature and Change From Baseline in Temperature at Week 32 (EOT/ET)
timeFrame: Baseline and Week 32 (EOT/ET)
measure: Baseline, Absolute Week 32 Values for Respiratory Rate and Change From Baseline in Respiratory Rate at Week 32 (EOT/ET)
timeFrame: Baseline and Week 32 (EOT/ET)
measure: Number of Participants Who Were Anti-Drug Antibodies (ADA) Positive and Neutralizing Antibodies (NAb) Positive
timeFrame: Week 10, 16, 22, 24, 26, 28, 32
measure: Mean ADA Titers
timeFrame: Week 10, 16, 22, 24, 26, 28, 30, 32
measure: Mean NAb Titers
timeFrame: Week 10, 16, 22, 24, 26, 28, 30, 32
Other outcomes:
Locations:
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Gradiska
country: Bosnia and Herzegovina
facility: Health Center Gradiska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
city: Sarajevo
country: Bosnia and Herzegovina
facility: General Hospital Prim. Dr.Abdulah Nakas
city: Pleven
country: Bulgaria
facility: UMHAT "Dr Georgi Stranski" EAD
city: Plovdiv
country: Bulgaria
facility: DCC Sveti Georgi
city: Plovdiv
country: Bulgaria
facility: Unimed Medical Centre
city: Brno
country: Czechia
facility: IMEDICA s.r.o.
city: Brno
country: Czechia
facility: Lekarna Na Lidicke
city: Brno
country: Czechia
facility: Lekarna Biovita
city: Brno
country: Czechia
facility: X-Medica, s.r.o.
city: Brno
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o.
city: Hlucin
country: Czechia
facility: L.K.N. Arthrocentrum, s.r.o.
city: Hlucin
country: Czechia
facility: Plicni ambulance
city: Olomouc
country: Czechia
facility: Chirurgie Sibenik
city: Olomouc
country: Czechia
facility: CTCenter MaVe s.r.o
city: Olomouc
country: Czechia
facility: Lekarna u Pottingea
city: Ostrava
country: Czechia
facility: Lekarna Vesalion
city: Pardubice
country: Czechia
facility: CCR Czech a.s.
city: Pardubice
country: Czechia
facility: Lekarna BENU
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Praha 5
country: Czechia
facility: Fakultni Nemocnice v Motole
city: Praha
country: Czechia
facility: Lekarna Pod Platany
city: Praha
country: Czechia
facility: CCR Prague s.r.o.
city: Praha
country: Czechia
facility: Diagnostické centrum Olšanská s.r.o.
city: Uherske Hradiste
country: Czechia
facility: Lekarna Hradebni s.r.o.
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Uherske Hradiste
country: Czechia
facility: Radiodiagnosticka ordinace a pracoviste
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences, Kauno klinikos
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Bialystok
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
city: Bialystok
country: Poland
facility: NZOZ Osteo-Medic s.c. A.Racewicz, J. Supronik
city: Krakow
country: Poland
facility: Małopolskie Badania Kliniczne Sp. z o. o. Sp. k.
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych REUMED
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED s.c.
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia Centrum Medyczne Nowa Sol
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warszawa
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Moscow
country: Russian Federation
facility: Limited Liability Company "Clinic on Maroseyka"
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company Consultative and Diagnostic Rheumatological Center "Healthy Joints"
city: Orenburg
country: Russian Federation
facility: FGBOU VO "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
city: Orenburg
country: Russian Federation
facility: GBUZ "Orenburg Regional Clinical Hospital"
city: Petrozavodsk
country: Russian Federation
facility: SBHI of the Republic of Karelia "Republican Hospital n. a. V.A. Baranov"
city: Ryazan
country: Russian Federation
facility: FSBEI of HE "Ryazan State Medical University n. a academician I.P.Pavlov"
city: Ryazan
country: Russian Federation
facility: SBI of the Ryazan Region "Regional Clinical Cardiology dispensary"
city: Ryazan
country: Russian Federation
facility: SBI of Ryazan Region "Regional Clinical Hospital"
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
city: Vladimir
country: Russian Federation
facility: LLC "BioMed"
city: Yaroslavl
country: Russian Federation
facility: LLC "Center for Medical Advice and Research-PRACTICE"
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Niska Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation Niska Banja
city: Novi Sad
country: Serbia
facility: Special Hospital for Rheumatic Diseases Novi Sad
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Jakaranda Hospital
state: Gauteng
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trials
state: Western CAPE
city: Cape Town
country: South Africa
facility: Panorama Medical Centre
state: Western CAPE
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre
state: Western CAPE
city: Kharkiv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady Oblasna klinichna likarnia
city: Kyiv
country: Ukraine
facility: Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu " Instytut revmatolohii "
city: Kyiv
country: Ukraine
facility: Derzhavna ustanova Natsionalnyi naukovyi tsentr Instytut kardiolohii imeni akademika M.D. Strazheska
city: M. Ivano-Frankivsk
country: Ukraine
facility: Komunalne Nekomertsiine Pidpryiemstvo "Tsentralna Miska Klinichna Likarnia
city: Odesa
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo "Odeska oblasna klinichna likarnia"
city: Odesa
country: Ukraine
facility: Bahatoprofilnyi medychnyi tsentr Odeskoho natsionalnoho medychnoho universytetu
city: Vinnytsia
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo "Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
city: Zhytomyr
country: Ukraine
facility: Komunalne pidpryiemstvo "Likarnia No 1" Zhytomyrskoi miskoi rady
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: