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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413617
• Other study ID #: B7921023
• Secondary ID: 2019-002676-14
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2020
• Est. completion date: February 7, 2022

Study information

• Verified date: March 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: February 7, 2022
• Est. primary completion date: February 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• History of any lymphoproliferative disorder.

• Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease.

• History of any prior deep vein thrombosis (DVT) or pulmonary embolism [PE].

• Recent (within 6 months of screening) myocardial infarction, coronary revascularization, or percutaneous angioplasty with or without placement of a coronary artery stent; acute coronary syndrome; chronic uncompensated heart failure or New York Heart Association Functional Class III or IV; left ventricular assist devices; implanted defibrillators.

• Current severe chronic renal insufficiency or renal failure as defined by persistent (on repeated measurements) eGFR <60 mL/min per 1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) calculation.

• Any known coagulopathy or hypercoagulant syndrome.

• Presence of any of the following laboratory abnormalities at screening or within the 3 months prior to first study dose:

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels =1.5 x the upper limit of normal (ULN); Participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is = ULN and other liver function assessments are normal; Absolute neutrophil count of <1.5 x 109/L (<1500/mm3). Participants with cyclic (benign ethnic) neutropenia will be excluded; Absolute lymphocyte count of <0.5 x 109/L (<500/mm3); Absolute white blood cell (WBC) count of <3.0 x 109/L (<3000/mm3); Hemoglobin <9.0 g/dL (90 g/L); Platelet count =100 x 109/L (100,000 cells/mm3) or =1000 x 109/L (1,000,000 cells/mm3); Thrombocytopenia, as defined by a platelet count <100 x 109/L (<100,000/mm3) at screening visit or within the 3 months prior to first study dose. [Screening laboratory tests with abnormal results may be repeated once to confirm abnormal results. If results return to normal protocol acceptable limits within the 4-week screening period, the participant may enter the study].

• Grade 3 or greater laboratory abnormality based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity scale, except for the following that are allowed: Grade 3 prothrombin time (PT) secondary to warfarin treatment; Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy.

• Participants previously treated with a biologic DMARD (except for up to 25% of participants who may have been treated with 1, and only 1 prior TNF inhibitor) or any other recent DMARD treatment (eg, a JAK inhibitor), or participants currently treated with any other prohibited medications will be excluded.

• Prior use of tofacitinib or other JAK inhibitor in the context of a clinical trial is excluded. Concomitant use of tofacitinib (other than as prescribed by the randomization scheme) or other JAK inhibitor is prohibited.

• Participants who have previously been treated with other, non-TNFa inhibiting biologic DMARDs [including, abatacept (Orencia®), tocilizumab (Actemra®), Sarilumab (Kevzara®), anakinra (Kineret®), rituximab (Rituxan®) or other selective B lymphocyte depleting agents, or other lymphocyte depleting agents/therapies (such as alemtuzab [CamPath®], natalizumab (Tysabri®), alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation) are excluded from participation in the study.

• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of IP used in this study (whichever is longer).

• Any 12-lead electrocardiogram (ECG) performed prior to randomization that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• PF-06650833
400 mg
• PF-06651600
100 mg
• Tofacitinib
11 mg

Locations

Country	Name	City	State
Bulgaria	,,UMHAT - Georgi Stranski" EAD	Pleven
Bulgaria	DCC Sveti Georgi EOOD	Plovdiv
Bulgaria	Independent Medical Diagnostic Laboratory Mediscan EOOD	Plovdiv
Bulgaria	Medical Diagnostic Laboratory Rusev EOOD	Plovdiv
Bulgaria	MHAT Plovdiv AD	Plovdiv
Bulgaria	"Medical Center-Teodora" EOOD	Ruse
Bulgaria	UMHAT "Kanev" AD	Ruse
Bulgaria	"DCC 17 - Sofia" EOOD	Sofia
Bulgaria	Medical Center "N.I. Pirogov" EOOD	Sofia
Bulgaria	Medical Center "Spectar" OOD	Sofia
Bulgaria	MHAT "Lyulin" EAD	Sofia
Bulgaria	UMHAT "Sveti Ivan Rilski" EAD	Sofia
Canada	Centre de Rhumatologie de l'Est du Quebec (CREQ)	Rimouski	Quebec
Canada	Manitoba Clinic	Winnipeg	Manitoba
Chile	Centro de Estudios Reumatologicos (CER)	Santiago	Region Metropolitana
Chile	Centro Radiologico Plaza Baquedano	Santiago	Region Metropolitana
Chile	Centro Radiologico San Vicente de Paul	Santiago	Region Metropolitana
Chile	CTR Estudios	Santiago	Region Metropolitana
Chile	Enroll SpA	Santiago	Region Metropolitana
Chile	IMARED	Santiago	Region Metropolitana
Czechia	HV Medical s.r.o., ORL ambulance pro deti a dospele	Brno
Czechia	Revmacentrum MUDr. Mostera, s.r.o.	Brno
Czechia	REVMACLINIC s.r.o.	Brno
Czechia	MRI Lekarsky servis s.r.o.	Havirov
Czechia	CCR Ostrava, s.r.o.	Ostrava
Czechia	Mestka nemocnice Ostrava	Ostrava
Czechia	Vesalion s.r.o.	Ostrava
Czechia	Poliklinika AMO - Audiologie	Ostrava - Kuncice
Czechia	CCR Czech a.s.	Pardubice	Vychodocesky KRAJ
Czechia	ORL - sluchadla s.r.o.	Pardubice
Czechia	Poliklinika Vektor	Pardubice
Czechia	Revmatologicky ustav	Praha 2
Czechia	Thomayerova nemocnice	Praha 4
Czechia	Medical Plus s.r.o.	Uherske Hradiste
Czechia	ORL ambulance	Uherske Hradiste
Czechia	Uherskohradistska nemocnice, a.s.	Uherske Hradiste
Georgia	JSC "Evex Hospitals"	Tbilisi
Georgia	LTD "Cardioclinic - Digomi Medical Center"	Tbilisi
Georgia	LTD "Institute of Clinical Cardiology"	Tbilisi
Georgia	LTD "MediClub Georgia"	Tbilisi
Georgia	LTD "Multi-Profile Clinic Consilium Medulla"	Tbilisi
Hungary	Trial Pharma Kft.	Bekescsaba
Hungary	Vasutegeszsegugyi Nonprofit Kozhasznu Tarsasag	Bekescsaba
Hungary	Affidea Magyarorszag Kft.	Budapest
Hungary	Affidea Magyarország Kft. Bank Center Központ	Budapest
Hungary	Affidea Magyarorszag Kft. Vaci Greens Egeszsegkozpont	Budapest
Hungary	Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz	Budapest
Hungary	Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz	Budapest
Hungary	Budai Irgalmasrendi Korhaz	Budapest
Hungary	Magyar Honvédség Egészségügyi Központ	Budapest
Hungary	Mammut Egeszsegkozpont, Ful-orr- gegeszet	Budapest
Hungary	Mediszintech Audiologia Kft.	Budapest
Hungary	Qualiclinic Kft.	Budapest
Hungary	Revita Reumatologiai Rendelo	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Debreceni Egyetem Klinikai Központ	Debrecen
Hungary	Sanitas Diagnosztikai es Rehabilitacios Kozpont	Gyula
Hungary	Pest Megyei Flór Ferenc Kórház Fül- Orr- Gégészet és Gyermek Fül-Orr-Gégészet	Kistarcsa
Hungary	Pest Megyei Flór Ferenc Kórház Reumatológiai es Fizioterápiás Osztály	Kistarcsa
Hungary	Huniko Kereskedelmi és Egészségügyi Szolgáltató Kft.	Miskolc
Hungary	Szegedi Tudomanyegyetem	Szeged
Hungary	Szegedi Tudomanyegyetem Reumatologiai Klinika	Szeged
Hungary	Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Hungary	Csolnoky Ferenc Korhaz, Ful- Orr- Gegeszeti Osztaly	Veszprem
Hungary	VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)	Veszprém
Poland	ClinicMed Daniluk, Nowak Sp. J.	Bialystok
Poland	Lar-Med	Bialystok
Poland	NZOZ Kendron	Bialystok
Poland	Nzoz Zdrowie Osteo-Medic	Bialystok
Poland	Podlaskie Centrum Sluchu i Mowy Sluchmed	Bialystok
Poland	Tomma Diagnostyka obrazowa	Bialystok
Poland	Klinika Foniatrii i Audiologii, Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej	Bydgoszcz
Poland	Nzoz McD Voxel	Bydgoszcz
Poland	Centrum Medyczne Enel-Med., Oddzial Alfa Plaza - Gdynia	Gdynia
Poland	Centrum Medyczne Pratia Gdynia	Gdynia
Poland	Portowy Zaklad Opieki Zdrowotnej Sp. z o.o.	Gdynia
Poland	MCBK	Grodzisk Mazowiecki
Poland	Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II	Grodzisk Mazowiecki
Poland	Centrum Badan Klinicznych JCI	Krakow
Poland	Centrum Medycyny Profilaktycznej Sp. z o. o.	Krakow
Poland	Centrum Medyczne iMed24	Krakow
Poland	Centrum medyczne PLEJADY	Krakow
Poland	LUX MED.	Krakow
Poland	LUXMED	Krakow
Poland	Malopolskie Badania Kliniczne	Krakow
Poland	Pratia MCM Krakow	Krakow
Poland	FONMED	Nowa Sol
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sol
Poland	LIVMED Sp. z.o.o.	Nowy Tomysl
Poland	Ai Centrum Medyczne	Poznan
Poland	GEERS Dobry Sluch	Poznan
Poland	Pracownia Rezonansu Magnetycznego i RTG	Poznan
Poland	Prywatna Praktyka Lekarska Prof. dr hab. med. Pawel Hrycaj	Poznan
Poland	Tomma Diagnostyka Obrazowa S.A.	Poznan
Poland	"MTZ CLINICAL RESEARCH" Spolka z ograniczona odpowiedzialnoscia	Warszawa
Poland	"Reumatika - Centrum Reumatologii" NZOZ	Warszawa
Poland	ArtAna Anna Piotrowska	Warszawa
Poland	Centrum Mowy i Sluchu Medincus	Warszawa
Poland	Medycyna Kliniczna	Warszawa
Poland	Rex Medica Sport	Warszawa
Poland	Spoldzielnia Pracy Specjalistow Rentgenologow im. prof. W. Zawadowskiego	Warszawa
Poland	Szpital LUX MED	Warszawa
Poland	Tomma Diagnostyka Obrazowa	Warszawa
Slovakia	Dermatovenerologicka ambulancia	Bratislava
Slovakia	ORL ambulancia RHINO s.r.o.	Bratislava
Slovakia	ROMJAN, s.r.o.	Bratislava
Slovakia	ARTROMAC n. o.	Kosice
Slovakia	Klinika dermatovenerologie UNLP	Kosice
Slovakia	Oddelenie radiodiagnostiky a zobrazovacich metod, UNLP	Kosice
Slovakia	Poliklinika Terasa s.r.o.	Kosice
Slovakia	Dermabene, s.r.o	Martin
Slovakia	MEDMAN, s. r. o.,	Martin
Slovakia	ORL ML, s.r.o	Martin
Slovakia	Jessenius - Diagnosticke centrum	Nitra
Slovakia	Otorinolaryngologicka ambulancia MUDr. Olga Salgova	Partizanske
Slovakia	PARDERM, s. r. o., Dermatovenerologicka ambulancia	Partizanske
Slovakia	REUMACENTRUM s.r.o.	Partizanske
Slovakia	MEDICENTRUM Piestany, s.r.o.	Piestany
Slovakia	Narodny ustav reumatickych chorob	Piestany
Slovakia	Nemocnica Alexandra Wintera n.o.	Piestany
Slovakia	AZIMED-ORL s.r.o.	Rimavska Sobota
Slovakia	Dg.s.r.o. - Diagnosticke- centrum	Rimavska Sobota
Slovakia	REUMEX s.r.o.	Rimavska Sobota
Slovakia	Vseobecna nemocnica Rimavska Sobota	Rimavska Sobota
Slovakia	Spinn, s.r.o.	Ruzomberok
Slovakia	Zdravomak s.r.o. Topolcany	Topolcany
Spain	Clinica Sagrada Familia	Barcelona
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Clinica Gaias - Santiago	Santiago de Compostela	A Coruna
Spain	Grupo Hospitalario La Rosaleda - Hospital Nuestra Senora de la Esperanza	Santiago de Compostela	A Coruna
Spain	Hospital Clinico Universitario Santiago de Compostela	Santiago de Compostela
Spain	Hospital Quironsalud Infanta Luisa	Sevilla
Ukraine	Communal non-profit enterprise "Chernihiv Regional Hospital" of Chernihiv Regional Council	Chernihiv
Ukraine	Communal Non-commercial Enterprise of Kharkiv Regional Council	Kharkiv
Ukraine	"Revmocenter" LLC	Kyiv
Ukraine	Clinic of the State Institution "DF Chebotaryov Institute of Gerontology of the NAMS of Ukraine"	Kyiv
Ukraine	Communal non-profit enterprise "Kyiv City Clinical Hospital #3" of executive body of Kyiv	Kyiv
Ukraine	Limited Liability Company "Medical Centre "Consilium Medical"	Kyiv
Ukraine	Medical ???t?? of "Medical Clinic "Blagomed" LLC	Kyiv
Ukraine	Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC	Kyiv
Ukraine	Communal Non-Commercial Enterprise "Odesa Regional Clinical Hospital" of Odesa Regional Council	Odesa
Ukraine	Comunal Enterprise "Poltava Regional Clinical Hospital n. a. M.S. Sklifosovskogo of Poltava	Poltava
Ukraine	LLC "Modern Clinic"	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Bulgaria,  Canada,  Chile,  Czechia,  Georgia,  Hungary,  Poland,  Slovakia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	DAS28-CRP Remission (<2.6) Rates at Week 24	DAS28-CRP is derived using differential weighting given to 4 components: tender joint count, swollen joint count, patient global assessment, and CRP. Remission is defined as DAS28-CRP score <2.6. Remission rate = the number of responders (who had remission) / (number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)	Week 24
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), and Withdrawals Due to TEAEs	An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.	From first dose of study intervention (Day 1) to Week 28
Secondary	Number of Participants With Clinical Laboratory Abnormalities (Hematology and Chemistry, Without Regard to Baseline Abnormality)	Clinical laboratory abnormality was determined at the investigator's discretion.	From BL to Week 28
Secondary	Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria	Abnormality in change from BL in vital signs included: sitting/semi-supine diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg, systolic BP increase and decrease from BL of >=30mmHg	From BL to Week 28
Secondary	Number of Participants With Adverse Events of Special Interest	These AEs included severe and opportunistic infection AEs; herpes virus infection AEs; clinically significant categorical increases in hepatic enzymes AST, and ALT and total bilirubin, and potential cases meeting Hy's Law criteria for increased risk of drug induced liver injury (DILI); major adverse cardiovascular events, including pulmonary embolism and deep vein thrombosis, cerebrovascular accident; AEs for decreased renal function, acute kidney injury, clinically significant increases in serum creatinine (Scr) and decreases in estimated glomerular filtration rate (eGFR). Only participants with AEs mentioned above were reported in the table below.	From first dose of study intervention (Day 1) to Week 28
Secondary	Change From Baseline in DAS28-CRP at Week 24	DAS28 is a measure based on assessment of 28 joints for tenderness and swelling (tender and swollen joint counts). 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.	BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24
Secondary	American College of Rheumatology (ACR)20, ACR 50, ACR 70, and ACR 90 Responder Rates at Week 12 and Week 24	The American College of Rheumatology's definition for calculating improvement in rheumatoid arthritis (ACR20) is calculated as a >=20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and CRP. Similarly, ACR50, ACR70, and ACR 90 were calculated with the respective percent improvement. Responder rate = number of responders (who had ACR20/50/70/90 response)/(number of responders + non-responders + non-responder assigned by non-responder imputation [NRI] after removal of missingness due to COVID-19 and missing components at a given visit)	BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
Secondary	Change From Baseline in the Tender/Painful and Swollen Joint Count at Week 12 and Week 24	The endpoint included Tender/Painful Joint Count 68 (TJC68) and 28 (TJC28). TJC68 was assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful in upper body and upper/lower extremity. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). The 28-joints set is the subset of 68 joints set including the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. TJC28 was calculated by Pfizer from TJC68. Higher scores indicate higher level of disability.	BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24
Secondary	Change From Baseline in the Physician's Global Assessment (PhGA) of Arthritis at Week 12 and Week 24	PhGA of Arthritis is an evaluation done by investigator based on the participant's disease signs, functional capacity and physical examination, and should be independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS. Physician's Global Assessment score ranges from 0 to 100. Higher scores indicate higher level of disability. A negative value in change from BL indicates an improvement.	BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

External Links

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