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Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06650833
Placebo
Tofacitinib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female (including WOCBP) subjects between the ages of 18 and 75 years, inclusive.
  2. 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.

  3. The subject has active disease at both Screening and Baseline, as defined by both:

    • 6 joints tender or painful on motion, AND
    • 6 joints swollen; and fulfills 1 of the following 2 criteria at Screening:
    • High sensitivity C reactive protein (hsCRP) >7 mg/L at screening
    • Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr;
  4. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
  5. Subjects must be ACPA positive between screening and randomization.
  6. Subjects must have been taking oral MTX for at least 3 months at an adequate dose to determine that the subject had an inadequate response to MTX
  7. Up to 50 % of subjects may have received one (and only one) approved TNF-inhibiting biologic agent administered that was inadequately effective and/or not tolerated. The anti-TNF biologic could also have been discontinued due to lack of continued access.

Exclusion Criteria:

  1. Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.

  2. Subjects with any of the following infections or infections history:

    1. Any infection requiring treatment within 2 weeks prior to screening (Visit 1).
    2. Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days, or as otherwise judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months.
    3. Infected joint prosthesis at any time with the prosthesis still in situ.
    4. Recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    5. Subjects will be screened for HIV. Subjects who test positive for HIV will be excluded from the study.
    6. Subjects will be screened for hepatitis B virus infection and will be excluded if positive for hepatitis B surface antigen (HBsAg). Subjects with HBsAg negative testing but who test positive for hepatitis B core antibody (HBcAb) must have further testing for hepatitis B surface antibody (HBsAb). If HBsAb is negative, the subject will be excluded from the study.
    7. Subjects with clinically significant active hepatic disease or hepatic impairment by laboratory assessment.
    8. Subjects will be screened for hepatitis C virus (HCV Ab). Subjects with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA). Only subjects with negative HCV Ab or HCV RNA will be allowed to enroll in the study.
  3. Evidence of active or latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB)
  4. Pre-existing chronic autoimmune disease.

Sites / Locations

  • Clinical and Translational Research Center of Alabama, PC
  • Dory Hardy, PharmD
  • Southern Arizona VA Health care System
  • Robert W. Levin, MD,PA
  • Millennium Research
  • Arthritis & Rheumatic Care Center
  • Qps-Mra, Llc
  • Medical Associates of North Georgia
  • Graves Gilbert Clinic
  • Arthritis and Diabetes Clinic, Inc.
  • Ramesh C Gupta, M.D.
  • Accurate Clinical Management, LLC
  • Accurate Clinical Management, LLC
  • Accurate Clinical Management, LLC
  • DM Clinical Research
  • Canberra Hospital
  • Genesis Research Services
  • General Hospital "Prim.dr.Abdulah Nakas"
  • University Clinical Center Republic of Srpska
  • Health Center Gradiska
  • UMHAT Kaspela
  • MHAT Liulin
  • UMHAT "Sv.Ivan Rilski", Clinic of rheumatology
  • Medical Center Synexus Sofia EOOD
  • Specialized Hospital for Active Treatment of Oncology Diseases EAD, Department of Imaging Diagnostic
  • Poliklinika K-centar
  • Medicinski centar Kuna&Peric
  • CCBR Ostrava s.r.o.
  • Revmatologicka ambulance
  • Medical Plus s.r.o.
  • LTD Israeli-Georgian Medical Research Clinic HELSICORE
  • LTD " Diagnostic Service "
  • Ltd Institute of Clinical Cardiology
  • LTD Unimedi Kakheti
  • LTD "MediClubGeorgia"
  • Ltd "Medicore"
  • Unimedi Kakheti LTD
  • Knappschaftsklinikum Saar GmbH
  • Revita Reumatologiai Rendelo
  • Pest Megyei Flor Ferenc Korhaz
  • CRU Hungary Ltd.
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly
  • VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
  • Seoul National University hospital
  • Hanyang University Seoul hospital
  • Konkuk University Medical Center
  • The Catholic University of Korea, Seoul St.Mary's Hospital
  • Private Practice - Dr. Miguel Cortes Hernandez
  • Centro Peninsular de Investigacion Clinica S.C.P
  • Kohler & Milstein Research S.A de C.V
  • Centro de Alta Especialidad en Reumatología e Investigación del Potosi, S.C.
  • Szpital Specjalistyczny nr 1 w Bytomiu
  • Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • Synexus Polska Sp z o.o. Oddzial w Gdyni
  • McBk S.C.
  • Synexus Polska Sp.Zo.o.
  • Prywatna Praktyka Lekarska Prof. UM Dr hab. Med. Pawel Hrycaj
  • Synexus Polska Sp. z o.o.
  • Reumatika Centrum Reumatologii NZOZ
  • Synexus Polska Sp. z o.o. Oddział we Wroclawiu
  • Centrul Medical Unirea
  • Med Life
  • Centrul Medical Sana
  • Euroclinic Hospital
  • Spitalul Clinic de Recuperare Iasi
  • Spitalul Clinic Judetean de Urgenta Tirgu Mures
  • FSBEI HE "Kazan State Medical University" MoH of RF
  • FSBEI HE "Kazan State Medical University" MoH of RF
  • FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
  • SBHI of Moscow City Clinical Hospital # 1 n.a. N.I. Pirogov of Moscow Healthcare Department
  • FSBHI Central Clinical Hospital of Russian Academy of Sciences
  • State Budgetary Institution of Ryazan Region "Regional clinical cardiology dispensary"
  • LLC "Sanavita"
  • LLC "Sanavita"
  • Saint Petersburg State Budgetary Institution of Health Care "Clinical Rheumatology Hospital #25"
  • SBHI of VR "Regional Clinical Hospital"
  • Institute of Rheumatology
  • Military Medical Academy
  • Institute for Treatment and Rehabilitation "Niska Banja"
  • Special Hospital for Rheumatic Diseases Novi Sad
  • Reumacentrum s.r.o.
  • AAGS s.r.o., Reumatologicka ambulancia
  • Nemocnica Kosice-Saca, a.s.1.sukromna nemocnica
  • Neštátna Reumatologická ambulancia
  • REUMEX s.r.o. Reumatologicka ambulancia
  • Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.
  • Complejo Hospitalario Universitario de Santiago de Compostela
  • HM Hospital Nuestra Señora de La Esperanza
  • Hospital Universitario Cruces
  • Hospital Universitario A Coruña
  • Hospital Quironsalud Infanta Luisa
  • China Medical University Hospital
  • National Taiwan University Hospital
  • Taipei Medical University Hospital
  • Komunalnyi likuvalno-profilaktychnyi zaklad "Chernihivska oblasna likarnia",
  • Derzhavna ustanova "Natsionalnyi instytut terapii imeni L.T. Maloi
  • Komunalne nekomertsiine pidpryiemstvo "Konsultatyvno-diahnostychnyi tsentr"
  • Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu "Revmotsentr", m. Kyiv
  • Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova
  • Poltavska oblasna klinichna likarnia im. M.V. Sklifosovskoho,
  • Ternopilska universytetska likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi
  • Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne viddilennia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm 1: 20 mg QD

Arm 2: 60 mg QD

Arm 3: 200 mg QD

Arm 4: 400 mg QD

Placebo

Arm 5: Tofacitinib

Arm Description

PF-06650833 , 20 mg QD

PF-06650833, 60 mg QD

Pf-06650833, 200 mg QD

PF-06650833, 400 mg QD

Placebo, 0 mg BID

Tofacitinib 5 mg BID

Outcomes

Primary Outcome Measures

Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.

Secondary Outcome Measures

Change From Baseline in SDAI at Weeks 4 and 8
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. The descriptive summary of change from baseline in SDAI was based on a mixed effect model repeat measurement MMRM model with observed data. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI LDAS was SDAI<=11. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI remission was SDAI<=3.3. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 (ESR) LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Higher score indicated more disease activity. Total score range: 0-9.4. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR) [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 4, 8 and 12 Weeks
ACR20 was calculated as a 20% improvement in TJC and SJC and 20% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 4, 8 and 12 Weeks
ACR50 was calculated as a 50% improvement in TJC and SJC and 50% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 4, 8 and 12 Weeks
ACR70 was calculated as a 70% improvement in TJC and SJC and 70% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
The TJC (28) included the following joints: shoulders, elbows, wrists, metatarsophalangeal (MCP) joints, PIP joints, and knees. This count was calculated from the TJC (68) assessed. The SJC (28) included the same joints as TJC (28), and was calculated from the SJC 66 assessed for swelling.Sixty eight (68) joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. The 68 joints assessed were: temporomandibular, sternoclavicular, acromioclavicular; shoulder, elbow, wrist, MCPs, thumb interphalangeal, proximal interphalangeals, and distal interphalangeals; hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined. Sixty-six (66) joints were assessed for swelling, the same as those listed for TJC, excluding the right and left hip joints. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at 4, 8 and 12 Weeks
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the Physician's Global Assessment of Arthritis (PhGA) at 4, 8, and 12 Weeks
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and was independent of the participant's reported assessments of PtGA (patient's global assessment of arthritis). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme". Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator.
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Each parameter was evaluated against commonly used and widely accepted criteria. Clinical significance of laboratory parameters was determined at the investigator's discretion. The investigator judged the abnormality.
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Vital Signs tests included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse rate. Vital signs categorical summarization criteria were 1), systolic BP (SBP) <90 millimeters of mercury (mm Hg) or change from baseline (Chg) >=30mm Hg; diastolic BP (DBP) <50mm Hg or change from baseline >=20mm Hg; 2), pulse rate <40bpm or > 120bpm.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate using Fridericia's formula (QTcF interval), and QTc calculated using Bazett's correction factor (QTcB interval).
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
The urine sample was collected for central laboratory urinalysis and urine microscopy. The urinalysis included pH, protein, glucose, erythrocytes, leukocytes, ketones, nitrite, urobilinogen, urine bilirubin, urine hemoglobin, leukocyte esterase, granular casts, hyaline casts, bacteria, atypical, needle-like crystals urine, specific gravity, microscopy and urine albumin test.
Change From Baseline in the Patient's Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12
Patients assess the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12
Patients answer the following question: "Considering all the ways your arthritis affects you, how are you feeling today?" The patient's response is recorded using a 100 mm VAS. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. The higher score indicated more severe disease. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 4, 8, and 12
The HAQ-DI was defined as participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
The SF-36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The SF-36 summary scores range from 0-100, with higher scores representing better self-reported health. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12
The SF 36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains. These domains can also be summarized as physical component score (PCS) and mental component score (MCS). The PCS and MCS summary scores range from 0-100, with higher scores representing better self-reported health. The lower the score the more disability. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12
The EQ-5D-3L health state profile is a patient completed questionnaire designed to assess impact on health related quality of life in 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the 5 domains might have been used to calculate a single index value, also known as a utility score. The validity and reliability of the EQ-5D-3L have been established in a number of disease states, including RA. EQ-5D-3L scores marked health status from 0 and 100. There were notes at the both ends of the scale that the bottom rate (0) corresponded to " the worst health you could imagine", and the highest rate (100) corresponded to "the best health you could imagine". Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Week 12
The FACIT-F is a patient completed questionnaire consisting of 13 items that assess fatigue. Instrument scoring yields a range from 0 to 52, with higher scores representing better patient status (less fatigue). This questionnaire was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.

Full Information

First Posted
October 13, 2016
Last Updated
February 12, 2020
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02996500
Brief Title
Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate
Official Title
A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2, multicenter, randomized, double blind, double dummy, placebo and active-controlled, parallel group study to assess the efficacy and safety of PF 06650833 at Week 12 in subjects with moderate-severe, active, RA who have had an inadequate response to MTX. PF-06650833 or matching placebo tablets will be administered orally QD under fasting conditions, and tofacitinib or matching tofacitinib placebo tablets will be administered orally BID for 12 weeks in a blinded fashion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: 20 mg QD
Arm Type
Experimental
Arm Description
PF-06650833 , 20 mg QD
Arm Title
Arm 2: 60 mg QD
Arm Type
Experimental
Arm Description
PF-06650833, 60 mg QD
Arm Title
Arm 3: 200 mg QD
Arm Type
Experimental
Arm Description
Pf-06650833, 200 mg QD
Arm Title
Arm 4: 400 mg QD
Arm Type
Experimental
Arm Description
PF-06650833, 400 mg QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 0 mg BID
Arm Title
Arm 5: Tofacitinib
Arm Type
Active Comparator
Arm Description
Tofacitinib 5 mg BID
Intervention Type
Drug
Intervention Name(s)
PF-06650833
Intervention Description
Investigational
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Other Intervention Name(s)
Xeljanz
Intervention Description
Investigational
Primary Outcome Measure Information:
Title
Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12
Description
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in SDAI at Weeks 4 and 8
Description
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. The descriptive summary of change from baseline in SDAI was based on a mixed effect model repeat measurement MMRM model with observed data. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4 and 8
Title
Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks
Description
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI LDAS was SDAI<=11. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks
Description
The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI remission was SDAI<=3.3. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 (ESR) LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Higher score indicated more disease activity. Total score range: 0-9.4. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR) [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks
Description
The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 4, 8 and 12 Weeks
Description
ACR20 was calculated as a 20% improvement in TJC and SJC and 20% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 4, 8 and 12 Weeks
Description
ACR50 was calculated as a 50% improvement in TJC and SJC and 50% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 4, 8 and 12 Weeks
Description
ACR70 was calculated as a 70% improvement in TJC and SJC and 70% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Weeks 4, 8 and 12
Title
Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks
Description
The TJC (28) included the following joints: shoulders, elbows, wrists, metatarsophalangeal (MCP) joints, PIP joints, and knees. This count was calculated from the TJC (68) assessed. The SJC (28) included the same joints as TJC (28), and was calculated from the SJC 66 assessed for swelling.Sixty eight (68) joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. The 68 joints assessed were: temporomandibular, sternoclavicular, acromioclavicular; shoulder, elbow, wrist, MCPs, thumb interphalangeal, proximal interphalangeals, and distal interphalangeals; hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined. Sixty-six (66) joints were assessed for swelling, the same as those listed for TJC, excluding the right and left hip joints. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at 4, 8 and 12 Weeks
Description
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in the Physician's Global Assessment of Arthritis (PhGA) at 4, 8, and 12 Weeks
Description
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and was independent of the participant's reported assessments of PtGA (patient's global assessment of arthritis). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme". Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs
Description
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator.
Time Frame
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Title
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Description
Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Each parameter was evaluated against commonly used and widely accepted criteria. Clinical significance of laboratory parameters was determined at the investigator's discretion. The investigator judged the abnormality.
Time Frame
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Title
Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria
Description
Vital Signs tests included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse rate. Vital signs categorical summarization criteria were 1), systolic BP (SBP) <90 millimeters of mercury (mm Hg) or change from baseline (Chg) >=30mm Hg; diastolic BP (DBP) <50mm Hg or change from baseline >=20mm Hg; 2), pulse rate <40bpm or > 120bpm.
Time Frame
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Title
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria
Description
ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate using Fridericia's formula (QTcF interval), and QTc calculated using Bazett's correction factor (QTcB interval).
Time Frame
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Title
Number of Participants With Urinalysis Data Meeting Pre-specified Criteria
Description
The urine sample was collected for central laboratory urinalysis and urine microscopy. The urinalysis included pH, protein, glucose, erythrocytes, leukocytes, ketones, nitrite, urobilinogen, urine bilirubin, urine hemoglobin, leukocyte esterase, granular casts, hyaline casts, bacteria, atypical, needle-like crystals urine, specific gravity, microscopy and urine albumin test.
Time Frame
Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)
Title
Change From Baseline in the Patient's Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12
Description
Patients assess the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12
Description
Patients answer the following question: "Considering all the ways your arthritis affects you, how are you feeling today?" The patient's response is recorded using a 100 mm VAS. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. The higher score indicated more severe disease. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 4, 8, and 12
Description
The HAQ-DI was defined as participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline, Weeks 4, 8 and 12
Title
Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12
Description
The SF-36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The SF-36 summary scores range from 0-100, with higher scores representing better self-reported health. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline and Week 12
Title
Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12
Description
The SF 36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains. These domains can also be summarized as physical component score (PCS) and mental component score (MCS). The PCS and MCS summary scores range from 0-100, with higher scores representing better self-reported health. The lower the score the more disability. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline and Week 12
Title
Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12
Description
The EQ-5D-3L health state profile is a patient completed questionnaire designed to assess impact on health related quality of life in 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the 5 domains might have been used to calculate a single index value, also known as a utility score. The validity and reliability of the EQ-5D-3L have been established in a number of disease states, including RA. EQ-5D-3L scores marked health status from 0 and 100. There were notes at the both ends of the scale that the bottom rate (0) corresponded to " the worst health you could imagine", and the highest rate (100) corresponded to "the best health you could imagine". Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline and Week 12
Title
Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Week 12
Description
The FACIT-F is a patient completed questionnaire consisting of 13 items that assess fatigue. Instrument scoring yields a range from 0 to 52, with higher scores representing better patient status (less fatigue). This questionnaire was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female (including WOCBP) subjects between the ages of 18 and 75 years, inclusive. 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 subject has active disease at both Screening and Baseline, as defined by both: 6 joints tender or painful on motion, AND 6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: High sensitivity C reactive protein (hsCRP) >7 mg/L at screening Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr; Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA. Subjects must be ACPA positive between screening and randomization. Subjects must have been taking oral MTX for at least 3 months at an adequate dose to determine that the subject had an inadequate response to MTX Up to 50 % of subjects may have received one (and only one) approved TNF-inhibiting biologic agent administered that was inadequately effective and/or not tolerated. The anti-TNF biologic could also have been discontinued due to lack of continued access. Exclusion Criteria: Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency. Subjects with any of the following infections or infections history: Any infection requiring treatment within 2 weeks prior to screening (Visit 1). Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days, or as otherwise judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months. Infected joint prosthesis at any time with the prosthesis still in situ. Recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex. Subjects will be screened for HIV. Subjects who test positive for HIV will be excluded from the study. Subjects will be screened for hepatitis B virus infection and will be excluded if positive for hepatitis B surface antigen (HBsAg). Subjects with HBsAg negative testing but who test positive for hepatitis B core antibody (HBcAb) must have further testing for hepatitis B surface antibody (HBsAb). If HBsAb is negative, the subject will be excluded from the study. Subjects with clinically significant active hepatic disease or hepatic impairment by laboratory assessment. Subjects will be screened for hepatitis C virus (HCV Ab). Subjects with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA). Only subjects with negative HCV Ab or HCV RNA will be allowed to enroll in the study. Evidence of active or latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB) Pre-existing chronic autoimmune disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Clinical and Translational Research Center of Alabama, PC
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
Dory Hardy, PharmD
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Southern Arizona VA Health care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Robert W. Levin, MD,PA
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Arthritis & Rheumatic Care Center
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Medical Associates of North Georgia
City
Canton
State/Province
Georgia
ZIP/Postal Code
30115
Country
United States
Facility Name
Graves Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Arthritis and Diabetes Clinic, Inc.
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Ramesh C Gupta, M.D.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Accurate Clinical Management, LLC
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Accurate Clinical Management, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Management, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Genesis Research Services
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
General Hospital "Prim.dr.Abdulah Nakas"
City
Sarajevo
State/Province
Kanton Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Republic of Srpska
City
Banja Luka
State/Province
Republika Srpska
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Health Center Gradiska
City
Gradiska
State/Province
Republika Srpska
ZIP/Postal Code
78400
Country
Bosnia and Herzegovina
Facility Name
UMHAT Kaspela
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
MHAT Liulin
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
UMHAT "Sv.Ivan Rilski", Clinic of rheumatology
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Medical Center Synexus Sofia EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Oncology Diseases EAD, Department of Imaging Diagnostic
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Poliklinika K-centar
City
Zagreb
State/Province
GRAD Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Medicinski centar Kuna&Peric
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
CCBR Ostrava s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Revmatologicka ambulance
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Medical Plus s.r.o.
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Facility Name
LTD Israeli-Georgian Medical Research Clinic HELSICORE
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD " Diagnostic Service "
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Ltd Institute of Clinical Cardiology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD Unimedi Kakheti
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
LTD "MediClubGeorgia"
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Ltd "Medicore"
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Unimedi Kakheti LTD
City
Telavi
ZIP/Postal Code
2200
Country
Georgia
Facility Name
Knappschaftsklinikum Saar GmbH
City
Puettlingen
ZIP/Postal Code
66346
Country
Germany
Facility Name
Revita Reumatologiai Rendelo
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
CRU Hungary Ltd.
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Seoul National University hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hanyang University Seoul hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St.Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Private Practice - Dr. Miguel Cortes Hernandez
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Centro Peninsular de Investigacion Clinica S.C.P
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Kohler & Milstein Research S.A de C.V
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatología e Investigación del Potosi, S.C.
City
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Szpital Specjalistyczny nr 1 w Bytomiu
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus Polska Sp z o.o. Oddzial w Gdyni
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
McBk S.C.
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Synexus Polska Sp.Zo.o.
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Prywatna Praktyka Lekarska Prof. UM Dr hab. Med. Pawel Hrycaj
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Synexus Polska Sp. z o.o.
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Reumatika Centrum Reumatologii NZOZ
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddział we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Centrul Medical Unirea
City
Bucuresti
ZIP/Postal Code
010306
Country
Romania
Facility Name
Med Life
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Centrul Medical Sana
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Euroclinic Hospital
City
Bucuresti
ZIP/Postal Code
014461
Country
Romania
Facility Name
Spitalul Clinic de Recuperare Iasi
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Tirgu Mures
City
Tirgu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
FSBEI HE "Kazan State Medical University" MoH of RF
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
FSBEI HE "Kazan State Medical University" MoH of RF
City
Kazan
ZIP/Postal Code
420103
Country
Russian Federation
Facility Name
FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
SBHI of Moscow City Clinical Hospital # 1 n.a. N.I. Pirogov of Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
FSBHI Central Clinical Hospital of Russian Academy of Sciences
City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
State Budgetary Institution of Ryazan Region "Regional clinical cardiology dispensary"
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
LLC "Sanavita"
City
Saint-Petersburg
ZIP/Postal Code
190031
Country
Russian Federation
Facility Name
LLC "Sanavita"
City
Saint-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Institution of Health Care "Clinical Rheumatology Hospital #25"
City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
SBHI of VR "Regional Clinical Hospital"
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Treatment and Rehabilitation "Niska Banja"
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Special Hospital for Rheumatic Diseases Novi Sad
City
Novi Sad
ZIP/Postal Code
21112
Country
Serbia
Facility Name
Reumacentrum s.r.o.
City
Partizanske
State/Province
Trenciansky Kraj.
ZIP/Postal Code
958 01
Country
Slovakia
Facility Name
AAGS s.r.o., Reumatologicka ambulancia
City
Dunajska Streda
ZIP/Postal Code
92901
Country
Slovakia
Facility Name
Nemocnica Kosice-Saca, a.s.1.sukromna nemocnica
City
Kosice-Saca
ZIP/Postal Code
040 15
Country
Slovakia
Facility Name
Neštátna Reumatologická ambulancia
City
Považská Bystrica
ZIP/Postal Code
017 01
Country
Slovakia
Facility Name
REUMEX s.r.o. Reumatologicka ambulancia
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.
City
Zilina
ZIP/Postal Code
010 01
Country
Slovakia
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
HM Hospital Nuestra Señora de La Esperanza
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15705
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Quironsalud Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10043
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Komunalnyi likuvalno-profilaktychnyi zaklad "Chernihivska oblasna likarnia",
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Derzhavna ustanova "Natsionalnyi instytut terapii imeni L.T. Maloi
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo "Konsultatyvno-diahnostychnyi tsentr"
City
Kyiv
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu "Revmotsentr", m. Kyiv
City
Kyiv
ZIP/Postal Code
04070
Country
Ukraine
Facility Name
Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Poltavska oblasna klinichna likarnia im. M.V. Sklifosovskoho,
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Ternopilska universytetska likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne viddilennia
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7921005
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

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