TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600 (RITLECITINIB) AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
2 other identifiers
interventional
460
10 countries
144
Brief Summary
Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Jul 2020
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedStudy Start
First participant enrolled
July 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2022
CompletedResults Posted
Study results publicly available
April 7, 2023
CompletedApril 7, 2023
March 1, 2023
1.5 years
May 19, 2020
February 6, 2023
March 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12
DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). Disease Activity Score 28-C reactive protein (DAS28-CRP) is derived using differential weighting given to 4 components: tender joint count (range: 0-28), swollen joint count (range: 0-28), patient global assessment (recorded on a visual analog scale \[VAS\] scale of 0-100 mm), and CRP (milligram per liter). DAS28-CRP score ranges from 0 to 9.4. The lower the DAS28-CRP score is, the better the participant has response (remission = score\<2.6, low disease activity = score≤3.2). A negative value in change from BL indicates an improvement. Mixed Model Repeated Measures was used for statistical analysis, which used the change from BL of DAS28-CRP as an outcome and treatment, scheduled study visit, BL value of DAS28-CRP, treatment by visit interaction and BL by visit interaction as fixed effects. The model used the unstructured covariance matrix.
BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12
Secondary Outcomes (9)
DAS28-CRP Remission (<2.6) Rates at Week 24
Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs
From first dose of study intervention (Day 1) to Week 28
Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)
From BL to Week 28
Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
From BL to Week 28
Number of Participants With Adverse Events of Special Interest
From first dose of study intervention (Day 1) to Week 28
- +4 more secondary outcomes
Study Arms (5)
PF-06650833 + tofacitinib
EXPERIMENTALPF-06650833 + PF-06651600
EXPERIMENTALPF-06650833
EXPERIMENTALPF-06651600
EXPERIMENTALTofacitinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female participants between the ages of 18 and 70 years.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA with a Total Score ≥6/10.
- The participant has active disease at both Screening and Randomization, as defined by both: ≥6 joints tender or painful on motion, AND ≥6 joints swollen; and fulfills 1 of the following 2 criteria: High sensitivity C reactive protein (hsCRP) \>7 mg/L at Screening (Visit 1) as performed by the central laboratory OR Erythrocyte sedimentation rate (ESR) (Westergren method) \>28 mm h.
You may not qualify if:
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Participants with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
- Participants with any active or latent infections.
- Participants with positive hepatitis B surface antigen (HBsAg).
- Participants with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA).
- Any history of either untreated or inadequately treated latent or active tuberculosis (TB) infection, current treatment for active or latent TB infection or evidence of currently active TB,
- History of a major organ transplant (eg, heart, lung, kidney and liver) or hematopoietic stem cell/marrow transplant.
- History of severe allergic or anaphylactoid reaction to kinase inhibitors, or corticosteroid preparations.
- Known history of diverticulitis or symptomatic diverticulosis, perineal abscess or fistulae.
- Participants with malignancy or history of malignancy (including lymphoma, leukemia, or lymphoproliferative disease).
- Pre-existing chronic autoimmune disease (eg, inflammatory bowel disease, systemic lupus erythematosus, moderate-severe atopic dermatitis, dermatomyositis) other than RA. Secondary Sjogren's Syndrome (due to RA) may be included.
- Participants with fibromyalgia will be excluded.
- Previous treatment with total lymphoid irradiation.
- Participants with an oral, tympanic, or temporal temperature of 38°C (100.4°F) or higher at baseline.
- Participants may not receive any live/attenuated vaccine from 30 days prior to randomization during the course of the study, or for 30 days after the last dose of study medication. Participants who have current routine household contact with children who have received varicella or oral polio vaccine within 2 months of first study dose are also excluded.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (144)
,,UMHAT - Georgi Stranski" EAD
Pleven, 5800, Bulgaria
Medical Diagnostic Laboratory Rusev EOOD
Plovdiv, 4000, Bulgaria
MHAT Plovdiv AD
Plovdiv, 4000, Bulgaria
DCC Sveti Georgi EOOD
Plovdiv, 4002, Bulgaria
Independent Medical Diagnostic Laboratory Mediscan EOOD
Plovdiv, Bulgaria
"Medical Center-Teodora" EOOD
Rousse, 7002, Bulgaria
UMHAT "Kanev" AD
Rousse, 7002, Bulgaria
Medical Center "Spectar" OOD
Sofia, 1113, Bulgaria
MHAT "Lyulin" EAD
Sofia, 1336, Bulgaria
"DCC 17 - Sofia" EOOD
Sofia, 1505, Bulgaria
Medical Center "N.I. Pirogov" EOOD
Sofia, 1612, Bulgaria
UMHAT "Sveti Ivan Rilski" EAD
Sofia, 1612, Bulgaria
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3, Canada
Centre de Rhumatologie de l'Est du Quebec (CREQ)
Rimouski, Quebec, G5L 8W1, Canada
Centro Radiologico San Vicente de Paul
Santiago, Santiago Metropolitan, 7500509, Chile
CTR Estudios
Santiago, Santiago Metropolitan, 7500571, Chile
Enroll SpA
Santiago, Santiago Metropolitan, 7500587, Chile
Centro Radiologico Plaza Baquedano
Santiago, Santiago Metropolitan, 7500906, Chile
IMARED
Santiago, Santiago Metropolitan, 7501070, Chile
Centro de Estudios Reumatologicos (CER)
Santiago, Santiago Metropolitan, 7501126, Chile
CCR Czech a.s.
Pardubice, Vychodocesky KRAJ, 53002, Czechia
REVMACLINIC s.r.o.
Brno, 61141, Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno, 615 00, Czechia
HV Medical s.r.o., ORL ambulance pro deti a dospele
Brno, 635 00, Czechia
MRI Lekarsky servis s.r.o.
Havířov, 736 01, Czechia
CCR Ostrava, s.r.o.
Ostrava, 702 00, Czechia
Vesalion s.r.o.
Ostrava, 702 00, Czechia
Mestka nemocnice Ostrava
Ostrava, 728 80, Czechia
Poliklinika AMO - Audiologie
Ostrava-Kunčice, 70702, Czechia
ORL - sluchadla s.r.o.
Pardubice, 530 02, Czechia
Poliklinika Vektor
Pardubice, 530 02, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
Thomayerova nemocnice
Prague, 140 59, Czechia
ORL ambulance
Uherské Hradiště, 686 01, Czechia
Uherskohradistska nemocnice, a.s.
Uherské Hradiště, 686 68, Czechia
Medical Plus s.r.o.
Uherské Hradiště, 68601, Czechia
JSC "Evex Hospitals"
Tbilisi, 0159, Georgia
LTD "Cardioclinic - Digomi Medical Center"
Tbilisi, 0159, Georgia
LTD "Institute of Clinical Cardiology"
Tbilisi, 0159, Georgia
LTD "MediClub Georgia"
Tbilisi, 0160, Georgia
LTD "Multi-Profile Clinic Consilium Medulla"
Tbilisi, 0186, Georgia
Trial Pharma Kft.
Békéscsaba, 5600, Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Tarsasag
Békéscsaba, 5600, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Budapest, 1023, Hungary
Mammut Egeszsegkozpont, Ful-orr- gegeszet
Budapest, 1024, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz
Budapest, 1027, Hungary
Budai Irgalmasrendi Korhaz
Budapest, 1027, Hungary
Revita Reumatologiai Rendelo
Budapest, 1027, Hungary
Qualiclinic Kft.
Budapest, 1036, Hungary
Affidea Magyarorszag Kft.
Budapest, 1054, Hungary
Affidea Magyarország Kft. Bank Center Központ
Budapest, 1054, Hungary
Magyar Honvédség Egészségügyi Központ
Budapest, 1062, Hungary
Affidea Magyarorszag Kft. Vaci Greens Egeszsegkozpont
Budapest, 1138, Hungary
Mediszintech Audiologia Kft.
Budapest, 1148, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Sanitas Diagnosztikai es Rehabilitacios Kozpont
Gyula, 5700, Hungary
Pest Megyei Flór Ferenc Kórház Fül- Orr- Gégészet és Gyermek Fül-Orr-Gégészet
Kistarcsa, 2143, Hungary
Pest Megyei Flór Ferenc Kórház Reumatológiai es Fizioterápiás Osztály
Kistarcsa, 2143, Hungary
Huniko Kereskedelmi és Egészségügyi Szolgáltató Kft.
Miskolc, 3530, Hungary
Szegedi Tudomanyegyetem Reumatologiai Klinika
Szeged, 6725, Hungary
Szegedi Tudomanyegyetem
Szeged, 6725, Hungary
Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, 6725, Hungary
Csolnoky Ferenc Korhaz, Ful- Orr- Gegeszeti Osztaly
Veszprém, 8200, Hungary
VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)
Veszprém, 8200, Hungary
Podlaskie Centrum Sluchu i Mowy Sluchmed
Bialystok, 15-222, Poland
Nzoz Zdrowie Osteo-Medic
Bialystok, 15-351, Poland
Lar-Med
Bialystok, 15-369, Poland
NZOZ Kendron
Bialystok, 15-402, Poland
Tomma Diagnostyka obrazowa
Bialystok, 15-471, Poland
ClinicMed Daniluk, Nowak Sp. J.
Bialystok, 15-879, Poland
Nzoz McD Voxel
Bydgoszcz, 85-015, Poland
Klinika Foniatrii i Audiologii, Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Bydgoszcz, 85-168, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338, Poland
Portowy Zaklad Opieki Zdrowotnej Sp. z o.o.
Gdynia, 81-338, Poland
Centrum Medyczne Enel-Med., Oddzial Alfa Plaza - Gdynia
Gdynia, 81-366, Poland
MCBK
Grodzisk Mazowiecki, 05-825, Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, 05-825, Poland
Malopolskie Badania Kliniczne
Krakow, 30-002, Poland
LUX MED.
Krakow, 30-004, Poland
Centrum Badan Klinicznych JCI
Krakow, 30-348, Poland
Centrum medyczne PLEJADY
Krakow, 30-363, Poland
LUXMED
Krakow, 30-421, Poland
Pratia MCM Krakow
Krakow, 30-510, Poland
Centrum Medycyny Profilaktycznej Sp. z o. o.
Krakow, 31-513, Poland
Centrum Medyczne iMed24
Krakow, 31-864, Poland
FONMED
Nowa Sól, 67-100, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
LIVMED Sp. z.o.o.
Nowy Tomyśl, 64-300, Poland
Ai Centrum Medyczne
Poznan, 61-113, Poland
Tomma Diagnostyka Obrazowa S.A.
Poznan, 61-361, Poland
GEERS Dobry Sluch
Poznan, 61-397, Poland
Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj
Poznan, 61-397, Poland
Pracownia Rezonansu Magnetycznego i RTG
Poznan, 61-545, Poland
Centrum Mowy i Sluchu Medincus
Warsaw, 00-024, Poland
Rex Medica Sport
Warsaw, 00-838, Poland
Medycyna Kliniczna
Warsaw, 00-874, Poland
Tomma Diagnostyka Obrazowa
Warsaw, 01-201, Poland
"MTZ CLINICAL RESEARCH" Spolka z ograniczona odpowiedzialnoscia
Warsaw, 02-106, Poland
"Reumatika - Centrum Reumatologii" NZOZ
Warsaw, 02-691, Poland
ArtAna Anna Piotrowska
Warsaw, 02-691, Poland
Spoldzielnia Pracy Specjalistow Rentgenologow im. prof. W. Zawadowskiego
Warsaw, 02-796, Poland
Szpital LUX MED
Warsaw, 02-801, Poland
Dermatovenerologicka ambulancia
Bratislava, 83103, Slovakia
ROMJAN, s.r.o.
Bratislava, 85101, Slovakia
ORL ambulancia RHINO s.r.o.
Bratislava, 85104, Slovakia
Klinika dermatovenerologie UNLP
Košice, 040 11, Slovakia
ARTROMAC n. o.
Košice, 04011, Slovakia
Oddelenie radiodiagnostiky a zobrazovacich metod, UNLP
Košice, 04011, Slovakia
Poliklinika Terasa s.r.o.
Košice, 04011, Slovakia
Dermabene, s.r.o
Martin, 03601, Slovakia
MEDMAN, s. r. o.,
Martin, 03601, Slovakia
ORL ML, s.r.o
Martin, 03601, Slovakia
Jessenius - Diagnosticke centrum
Nitra, 949 01, Slovakia
Otorinolaryngologicka ambulancia MUDr. Olga Salgova
Partizánske, 95801, Slovakia
PARDERM, s. r. o., Dermatovenerologicka ambulancia
Partizánske, 95801, Slovakia
REUMACENTRUM s.r.o.
Partizánske, 95801, Slovakia
MEDICENTRUM Piestany, s.r.o.
Piešťany, 92101, Slovakia
Narodny ustav reumatickych chorob
Piešťany, 92112, Slovakia
Nemocnica Alexandra Wintera n.o.
Piešťany, 92163, Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 12, Slovakia
AZIMED-ORL s.r.o.
Rimavská Sobota, 97901, Slovakia
Dg.s.r.o. - Diagnosticke- centrum
Rimavská Sobota, 97901, Slovakia
REUMEX s.r.o.
Rimavská Sobota, 97901, Slovakia
Spinn, s.r.o.
Ružomberok, 034 01, Slovakia
Zdravomak s.r.o. Topoľčany
Topoľčany, 95501, Slovakia
Clinica Gaias - Santiago
Santiago de Compostela, A Coruna, 15702, Spain
Grupo Hospitalario La Rosaleda - Hospital Nuestra Senora de la Esperanza
Santiago de Compostela, A Coruna, 15705, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Clinica Sagrada Familia
Barcelona, 08022, Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Quironsalud Infanta Luisa
Seville, 41010, Spain
Communal non-profit enterprise "Chernihiv Regional Hospital" of Chernihiv Regional Council
Chernihiv, 14029, Ukraine
Communal Non-commercial Enterprise of Kharkiv Regional Council
Kharkiv, 61058, Ukraine
Medical сепtег of "Medical Clinic "Blagomed" LLC
Kyiv, 01023, Ukraine
Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC
Kyiv, 02091, Ukraine
Communal non-profit enterprise "Kyiv City Clinical Hospital #3" of executive body of Kyiv
Kyiv, 02125, Ukraine
Limited Liability Company "Medical Centre "Consilium Medical"
Kyiv, 04050, Ukraine
"Revmocenter" LLC
Kyiv, 04071, Ukraine
Clinic of the State Institution "DF Chebotaryov Institute of Gerontology of the NAMS of Ukraine"
Kyiv, 04114, Ukraine
Communal Non-Commercial Enterprise "Odesa Regional Clinical Hospital" of Odesa Regional Council
Odesa, 65025, Ukraine
Comunal Enterprise "Poltava Regional Clinical Hospital n. a. M.S. Sklifosovskogo of Poltava
Poltava, 360011, Ukraine
LLC "Modern Clinic"
Zaporizhzhya, 69005, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
June 4, 2020
Study Start
July 29, 2020
Primary Completion
February 7, 2022
Study Completion
February 7, 2022
Last Updated
April 7, 2023
Results First Posted
April 7, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.