AzTrials
AzTrials

Rheumatoid ArthritisPhase 2NCT04413617

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 Phase 2 study testing PF-06650833, PF-06651600 and Tofacitinib in people with Rheumatoid Arthritis, run by Pfizer at 144 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
PF-06650833, PF-06651600 and Tofacitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
144 sitesin 10 countries
Study dates
29 Jul 2020to 7 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

144 sites in 10 countries.

144 sites in 10 countries

Poland39 sites

  • Podlaskie Centrum Sluchu i Mowy Sluchmed

    Bialystok, 15-222

  • Nzoz Zdrowie Osteo-Medic

    Bialystok, 15-351

  • Lar-Med

    Bialystok, 15-369

  • NZOZ Kendron

    Bialystok, 15-402

  • Tomma Diagnostyka obrazowa

    Bialystok, 15-471

  • ClinicMed Daniluk, Nowak Sp. J.

    Bialystok, 15-879

  • Nzoz McD Voxel

    Bydgoszcz, 85-015

  • Klinika Foniatrii i Audiologii, Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168

  • Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

    Bydgoszcz, 85-168

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • Portowy Zaklad Opieki Zdrowotnej Sp. z o.o.

    Gdynia, 81-338

  • Centrum Medyczne Enel-Med., Oddzial Alfa Plaza - Gdynia

    Gdynia, 81-366

  • MCBK

    Grodzisk Mazowiecki, 05-825

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II

    Grodzisk Mazowiecki, 05-825

  • Malopolskie Badania Kliniczne

    Krakow, 30-002

  • LUX MED.

    Krakow, 30-004

  • Centrum Badan Klinicznych JCI

    Krakow, 30-348

  • Centrum medyczne PLEJADY

    Krakow, 30-363

  • LUXMED

    Krakow, 30-421

  • Pratia MCM Krakow

    Krakow, 30-510

  • Centrum Medycyny Profilaktycznej Sp. z o. o.

    Krakow, 31-513

  • Centrum Medyczne iMed24

    Krakow, 31-864

  • FONMED

    Nowa Sól, 67-100

  • Twoja Przychodnia - Centrum Medyczne Nowa Sol

    Nowa Sól, 67-100

  • LIVMED Sp. z.o.o.

    Nowy Tomyśl, 64-300

  • Ai Centrum Medyczne

    Poznan, 61-113

  • Tomma Diagnostyka Obrazowa S.A.

    Poznan, 61-361

  • GEERS Dobry Sluch

    Poznan, 61-397

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

    Poznan, 61-397

  • Pracownia Rezonansu Magnetycznego i RTG

    Poznan, 61-545

  • Centrum Mowy i Sluchu Medincus

    Warsaw, 00-024

  • Rex Medica Sport

    Warsaw, 00-838

  • Medycyna Kliniczna

    Warsaw, 00-874

  • Tomma Diagnostyka Obrazowa

    Warsaw, 01-201

  • "MTZ CLINICAL RESEARCH" Spolka z ograniczona odpowiedzialnoscia

    Warsaw, 02-106

  • "Reumatika - Centrum Reumatologii" NZOZ

    Warsaw, 02-691

  • ArtAna Anna Piotrowska

    Warsaw, 02-691

  • Spoldzielnia Pracy Specjalistow Rentgenologow im. prof. W. Zawadowskiego

    Warsaw, 02-796

  • Szpital LUX MED

    Warsaw, 02-801

Other trials in Poland

Hungary24 sites

  • Trial Pharma Kft.

    Békéscsaba, 5600

  • Vasutegeszsegugyi Nonprofit Kozhasznu Tarsasag

    Békéscsaba, 5600

  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Mammut Egeszsegkozpont, Ful-orr- gegeszet

    Budapest, 1024

  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Budai Irgalmasrendi Korhaz

    Budapest, 1027

  • Revita Reumatologiai Rendelo

    Budapest, 1027

  • Qualiclinic Kft.

    Budapest, 1036

  • Affidea Magyarorszag Kft.

    Budapest, 1054

  • Affidea Magyarország Kft. Bank Center Központ

    Budapest, 1054

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 1062

  • Affidea Magyarorszag Kft. Vaci Greens Egeszsegkozpont

    Budapest, 1138

  • Mediszintech Audiologia Kft.

    Budapest, 1148

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Sanitas Diagnosztikai es Rehabilitacios Kozpont

    Gyula, 5700

  • Pest Megyei Flór Ferenc Kórház Fül- Orr- Gégészet és Gyermek Fül-Orr-Gégészet

    Kistarcsa, 2143

  • Pest Megyei Flór Ferenc Kórház Reumatológiai es Fizioterápiás Osztály

    Kistarcsa, 2143

  • Huniko Kereskedelmi és Egészségügyi Szolgáltató Kft.

    Miskolc, 3530

  • Szegedi Tudomanyegyetem Reumatologiai Klinika

    Szeged, 6725

  • Szegedi Tudomanyegyetem

    Szeged, 6725

  • Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

  • Csolnoky Ferenc Korhaz, Ful- Orr- Gegeszeti Osztaly

    Veszprém, 8200

  • VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)

    Veszprém, 8200

Other trials in Hungary

Slovakia23 sites

  • Dermatovenerologicka ambulancia

    Bratislava, 83103

  • ROMJAN, s.r.o.

    Bratislava, 85101

  • ORL ambulancia RHINO s.r.o.

    Bratislava, 85104

  • Klinika dermatovenerologie UNLP

    Košice, 040 11

  • ARTROMAC n. o.

    Košice, 04011

  • Oddelenie radiodiagnostiky a zobrazovacich metod, UNLP

    Košice, 04011

  • Poliklinika Terasa s.r.o.

    Košice, 04011

  • Dermabene, s.r.o

    Martin, 03601

  • MEDMAN, s. r. o.,

    Martin, 03601

  • ORL ML, s.r.o

    Martin, 03601

  • Jessenius - Diagnosticke centrum

    Nitra, 949 01

  • Otorinolaryngologicka ambulancia MUDr. Olga Salgova

    Partizánske, 95801

  • PARDERM, s. r. o., Dermatovenerologicka ambulancia

    Partizánske, 95801

  • REUMACENTRUM s.r.o.

    Partizánske, 95801

  • MEDICENTRUM Piestany, s.r.o.

    Piešťany, 92101

  • Narodny ustav reumatickych chorob

    Piešťany, 92112

  • Nemocnica Alexandra Wintera n.o.

    Piešťany, 92163

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

  • AZIMED-ORL s.r.o.

    Rimavská Sobota, 97901

  • Dg.s.r.o. - Diagnosticke- centrum

    Rimavská Sobota, 97901

  • REUMEX s.r.o.

    Rimavská Sobota, 97901

  • Spinn, s.r.o.

    Ružomberok, 034 01

  • Zdravomak s.r.o. Topoľčany

    Topoľčany, 95501

Other trials in Slovakia

Czechia16 sites

  • REVMACLINIC s.r.o.

    Brno, 61141

  • Revmacentrum MUDr. Mostera, s.r.o.

    Brno, 615 00

  • HV Medical s.r.o., ORL ambulance pro deti a dospele

    Brno, 635 00

  • MRI Lekarsky servis s.r.o.

    Havířov, 736 01

  • CCR Ostrava, s.r.o.

    Ostrava, 702 00

  • Vesalion s.r.o.

    Ostrava, 702 00

  • Mestka nemocnice Ostrava

    Ostrava, 728 80

  • Poliklinika AMO - Audiologie

    Ostrava-Kunčice, 70702

  • CCR Czech a.s.

    Pardubice, Vychodocesky KRAJ, 53002

  • ORL - sluchadla s.r.o.

    Pardubice, 530 02

  • Poliklinika Vektor

    Pardubice, 530 02

  • Revmatologicky ustav

    Prague, 128 50

  • Thomayerova nemocnice

    Prague, 140 59

  • ORL ambulance

    Uherské Hradiště, 686 01

  • Uherskohradistska nemocnice, a.s.

    Uherské Hradiště, 686 68

  • Medical Plus s.r.o.

    Uherské Hradiště, 68601

Other trials in Czechia

Bulgaria12 sites

  • ,,UMHAT - Georgi Stranski" EAD

    Pleven, 5800

  • Medical Diagnostic Laboratory Rusev EOOD

    Plovdiv, 4000

  • MHAT Plovdiv AD

    Plovdiv, 4000

  • DCC Sveti Georgi EOOD

    Plovdiv, 4002

  • Independent Medical Diagnostic Laboratory Mediscan EOOD

    Plovdiv

  • "Medical Center-Teodora" EOOD

    Rousse, 7002

  • UMHAT "Kanev" AD

    Rousse, 7002

  • Medical Center "Spectar" OOD

    Sofia, 1113

  • MHAT "Lyulin" EAD

    Sofia, 1336

  • "DCC 17 - Sofia" EOOD

    Sofia, 1505

  • Medical Center "N.I. Pirogov" EOOD

    Sofia, 1612

  • UMHAT "Sveti Ivan Rilski" EAD

    Sofia, 1612

Other trials in Bulgaria

Ukraine11 sites

  • Communal non-profit enterprise "Chernihiv Regional Hospital" of Chernihiv Regional Council

    Chernihiv, 14029

  • Communal Non-commercial Enterprise of Kharkiv Regional Council

    Kharkiv, 61058

  • Medical сепtег of "Medical Clinic "Blagomed" LLC

    Kyiv, 01023

  • Medical Center 'Ok!Clinic+' of International Institute of Clinical Research LLC

    Kyiv, 02091

  • Communal non-profit enterprise "Kyiv City Clinical Hospital #3" of executive body of Kyiv

    Kyiv, 02125

  • Limited Liability Company "Medical Centre "Consilium Medical"

    Kyiv, 04050

  • "Revmocenter" LLC

    Kyiv, 04071

  • Clinic of the State Institution "DF Chebotaryov Institute of Gerontology of the NAMS of Ukraine"

    Kyiv, 04114

  • Communal Non-Commercial Enterprise "Odesa Regional Clinical Hospital" of Odesa Regional Council

    Odesa, 65025

  • Comunal Enterprise "Poltava Regional Clinical Hospital n. a. M.S. Sklifosovskogo of Poltava

    Poltava, 360011

  • LLC "Modern Clinic"

    Zaporizhzhya, 69005

Other trials in Ukraine

Chile6 sites

  • Centro Radiologico San Vicente de Paul

    Santiago, Santiago Metropolitan, 7500509

  • CTR Estudios

    Santiago, Santiago Metropolitan, 7500571

  • Enroll SpA

    Santiago, Santiago Metropolitan, 7500587

  • Centro Radiologico Plaza Baquedano

    Santiago, Santiago Metropolitan, 7500906

  • IMARED

    Santiago, Santiago Metropolitan, 7501070

  • Centro de Estudios Reumatologicos (CER)

    Santiago, Santiago Metropolitan, 7501126

Other trials in Chile

Spain6 sites

  • Clinica Sagrada Familia

    Barcelona, 08022

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Clinica Gaias - Santiago

    Santiago de Compostela, A Coruna, 15702

  • Grupo Hospitalario La Rosaleda - Hospital Nuestra Senora de la Esperanza

    Santiago de Compostela, A Coruna, 15705

  • Hospital Clinico Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

Other trials in Spain

Georgia5 sites

  • JSC "Evex Hospitals"

    Tbilisi, 0159

  • LTD "Cardioclinic - Digomi Medical Center"

    Tbilisi, 0159

  • LTD "Institute of Clinical Cardiology"

    Tbilisi, 0159

  • LTD "MediClub Georgia"

    Tbilisi, 0160

  • LTD "Multi-Profile Clinic Consilium Medulla"

    Tbilisi, 0186

Other trials in Georgia

Canada2 sites

  • Centre de Rhumatologie de l'Est du Quebec (CREQ)

    Rimouski, Quebec, G5L 8W1

  • Manitoba Clinic

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

About this study

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

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

Being tested
PF-06650833, PF-06651600, Tofacitinib
Keywords
Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06650833Drug

    400 mg

  • PF-06651600Drug

    100 mg

  • TofacitinibDrug

    11 mg

Study groups in NCT04413617
Study groupRoleWhat they receive
PF-06650833 + tofacitinibExperimentalNot described
Receives: Drug: PF-06650833; Drug: Tofacitinib
PF-06650833 + PF-06651600ExperimentalNot described
Receives: Drug: PF-06650833; Drug: PF-06651600
PF-06650833ExperimentalNot described
Receives: Drug: PF-06650833
PF-06651600ExperimentalNot described
Receives: Drug: PF-06651600
TofacitinibExperimentalNot described
Receives: Drug: Tofacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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)

    Measured: Week 24

  2. 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.

    Measured: From first dose of study intervention (Day 1) to Week 28

  3. 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.

    Measured: From BL to Week 28

  4. 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

    Measured: From BL to Week 28

  5. 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.

    Measured: From first dose of study intervention (Day 1) to Week 28

  6. 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.

    Measured: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 24

  7. 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)

    Measured: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

  8. 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.

    Measured: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

  9. 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.

    Measured: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start29 Jul 2020
  3. Primary completion7 Feb 2022
  4. Study completion7 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
460 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04413617
Sponsor's protocol ID
B7921023
Other IDs
2019-002676-14, 2019
Status last verified
Mar 2023
First submitted
19 May 2020
Last updated
7 Apr 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06650833, PF-06651600 and Tofacitinib in people with Rheumatoid Arthritis, run by Pfizer at 144 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in Poland, Hungary, Slovakia, Czechia, Bulgaria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (BL) in Disease Activity Score (DAS)28-C Reactive Protein (CRP) at Week 12 (time frame: BL (defined as the last non-missing measurement collected prior to the first administration of study drug on Day 1), Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04413617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.

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