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

NCT ID: NCT02996500

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-10
• Study Completion Date: 2018-08-15

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1: 20 mg QD

PF-06650833 , 20 mg QD

Group Type: EXPERIMENTAL

PF-06650833

Intervention Type: DRUG

Investigational

Arm 2: 60 mg QD

PF-06650833, 60 mg QD

Group Type: EXPERIMENTAL

PF-06650833

Intervention Type: DRUG

Investigational

Arm 3: 200 mg QD

Pf-06650833, 200 mg QD

Group Type: EXPERIMENTAL

PF-06650833

Intervention Type: DRUG

Investigational

Arm 4: 400 mg QD

PF-06650833, 400 mg QD

Group Type: EXPERIMENTAL

PF-06650833

Intervention Type: DRUG

Investigational

Placebo

Placebo, 0 mg BID

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Arm 5: Tofacitinib

Tofacitinib 5 mg BID

Group Type: ACTIVE_COMPARATOR

Tofacitinib

Intervention Type: DRUG

Investigational

Interventions

PF-06650833

Investigational

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Tofacitinib

Investigational

Intervention Type: DRUG

Other Intervention Names

Xeljanz

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Clinical and Translational Research Center of Alabama, PC

Tuscaloosa, Alabama, United States

Dory Hardy, PharmD

Tucson, Arizona, United States

Southern Arizona VA Health care System

Tucson, Arizona, United States

Robert W. Levin, MD,PA

Clearwater, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

Arthritis & Rheumatic Care Center

South Miami, Florida, United States

Qps-Mra, Llc

South Miami, Florida, United States

Medical Associates of North Georgia

Canton, Georgia, United States

Graves Gilbert Clinic

Bowling Green, Kentucky, United States

Arthritis and Diabetes Clinic, Inc.

Monroe, Louisiana, United States

Ramesh C Gupta, M.D.

Memphis, Tennessee, United States

Accurate Clinical Management, LLC

Baytown, Texas, United States

Accurate Clinical Management, LLC

Houston, Texas, United States

Accurate Clinical Management, LLC

Houston, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Genesis Research Services

Broadmeadow, New South Wales, Australia

General Hospital "Prim.dr.Abdulah Nakas"

Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina

University Clinical Center Republic of Srpska

Banja Luka, Republika Srpska, Bosnia and Herzegovina

Health Center Gradiska

Gradiška, Republika Srpska, Bosnia and Herzegovina

UMHAT Kaspela

Plovdiv, , Bulgaria

MHAT Liulin

Sofia, , Bulgaria

UMHAT "Sv.Ivan Rilski", Clinic of rheumatology

Sofia, , Bulgaria

Medical Center Synexus Sofia EOOD

Sofia, , Bulgaria

Specialized Hospital for Active Treatment of Oncology Diseases EAD, Department of Imaging Diagnostic

Sofia, , Bulgaria

Poliklinika K-centar

Zagreb, City of Zagreb, Croatia

Medicinski centar Kuna&Peric

Zagreb, , Croatia

CCBR Ostrava s.r.o.

Ostrava, , Czechia

Revmatologicka ambulance

Prague, , Czechia

Medical Plus s.r.o.

Uherské Hradiště, , Czechia

LTD Israeli-Georgian Medical Research Clinic HELSICORE

Tbilisi, , Georgia

LTD " Diagnostic Service "

Tbilisi, , Georgia

Ltd Institute of Clinical Cardiology

Tbilisi, , Georgia

LTD Unimedi Kakheti

Tbilisi, , Georgia

LTD "MediClubGeorgia"

Tbilisi, , Georgia

Ltd "Medicore"

Tbilisi, , Georgia

Unimedi Kakheti LTD

Telavi, , Georgia

Knappschaftsklinikum Saar GmbH

Püttlingen, , Germany

Revita Reumatologiai Rendelo

Budapest, , Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, , Hungary

CRU Hungary Ltd.

Miskolc, , Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , Hungary

Csongrad Megyei Dr. Bugyi Istvan Korhaz, Mozgasszervi Rehabilitacios Osztaly

Szentes, , Hungary

VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont

Veszprém, , Hungary

Private Practice - Dr. Miguel Cortes Hernandez

Cuernavaca, Morelos, Mexico

Centro Peninsular de Investigacion Clinica S.C.P

Mérida, Yucatán, Mexico

Kohler & Milstein Research S.A de C.V

Mérida, Yucatán, Mexico

Centro de Alta Especialidad en Reumatología e Investigación del Potosi, S.C.

San Luis Potosí City, , Mexico

Szpital Specjalistyczny nr 1 w Bytomiu

Bytom, , Poland

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, , Poland

Synexus Polska Sp z o.o. Oddzial w Gdyni

Gdynia, , Poland

McBk S.C.

Grodzisk Mazowiecki, , Poland

Synexus Polska Sp.Zo.o.

Katowice, , Poland

Prywatna Praktyka Lekarska Prof. UM Dr hab. Med. Pawel Hrycaj

Poznan, , Poland

Synexus Polska Sp. z o.o.

Warsaw, , Poland

Reumatika Centrum Reumatologii NZOZ

Warsaw, , Poland

Synexus Polska Sp. z o.o. Oddział we Wroclawiu

Wroclaw, , Poland

Centrul Medical Unirea

Bucharest, , Romania

Med Life

Bucharest, , Romania

Centrul Medical Sana

Bucharest, , Romania

Euroclinic Hospital

Bucharest, , Romania

Spitalul Clinic de Recuperare Iasi

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Tirgu Mures

Târgu Mureş, , Romania

FSBEI HE "Kazan State Medical University" MoH of RF

Kazan', , Russia

FSBEI HE "Kazan State Medical University" MoH of RF

Kazan', , Russia

FSBSI "Scientific Research Institute of Rheumatology n.a. V.A. Nasonova"

Moscow, , Russia

SBHI of Moscow City Clinical Hospital # 1 n.a. N.I. Pirogov of Moscow Healthcare Department

Moscow, , Russia

FSBHI Central Clinical Hospital of Russian Academy of Sciences

Moscow, , Russia

State Budgetary Institution of Ryazan Region "Regional clinical cardiology dispensary"

Ryazan, , Russia

LLC "Sanavita"

Saint Petersburg, , Russia

Saint Petersburg State Budgetary Institution of Health Care "Clinical Rheumatology Hospital #25"

Saint Petersburg, , Russia

LLC "Sanavita"

Saint Petersburg, , Russia

SBHI of VR "Regional Clinical Hospital"

Vladimir, , Russia

Institute of Rheumatology

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Institute for Treatment and Rehabilitation "Niska Banja"

Niška Banja, , Serbia

Special Hospital for Rheumatic Diseases Novi Sad

Novi Sad, , Serbia

Reumacentrum s.r.o.

Partizánske, Trenčín Region, Slovakia

AAGS s.r.o., Reumatologicka ambulancia

Dunajská Streda, , Slovakia

Nemocnica Kosice-Saca, a.s.1.sukromna nemocnica

Kosice-Saca, , Slovakia

Neštátna Reumatologická ambulancia

Považská Bystrica, , Slovakia

REUMEX s.r.o. Reumatologicka ambulancia

Rimavská Sobota, , Slovakia

Reumatologicka ambulancia, MUDr. Pavol Polak s.r.o.

Žilina, , Slovakia

Seoul National University hospital

Seoul, , South Korea

Hanyang University Seoul hospital

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, , South Korea

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, Spain

HM Hospital Nuestra Señora de La Esperanza

Santiago de Compostela, A Coruña, Spain

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Hospital Universitario A Coruña

A Coruña, , Spain

Hospital Quironsalud Infanta Luisa

Seville, , Spain

China Medical University Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Komunalnyi likuvalno-profilaktychnyi zaklad "Chernihivska oblasna likarnia",

Chernihiv, , Ukraine

Derzhavna ustanova "Natsionalnyi instytut terapii imeni L.T. Maloi

Kharkiv, , Ukraine

Komunalne nekomertsiine pidpryiemstvo "Konsultatyvno-diahnostychnyi tsentr"

Kyiv, , Ukraine

Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu "Revmotsentr", m. Kyiv

Kyiv, , Ukraine

Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova

Kyiv, , Ukraine

Poltavska oblasna klinichna likarnia im. M.V. Sklifosovskoho,

Poltava, , Ukraine

Ternopilska universytetska likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi

Ternopil, , Ukraine

Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne viddilennia

Vinnytsia, , Ukraine

Countries

United States; Australia; Bosnia and Herzegovina; Bulgaria; Croatia; Czechia; Georgia; Germany; Hungary; Mexico; Poland; Romania; Russia; Serbia; Slovakia; South Korea; Spain; Taiwan; Ukraine

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B7921005

To obtain contact information for a study center near you, click here.

Other Identifiers

2016-002337-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IRAK 4

Identifier Type: OTHER

Identifier Source: secondary_id

B7921005

Identifier Type: -

Identifier Source: org_study_id