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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02996500

Run by

Pfizer

People needed

269

Starts

2016-11-10

Expected to finish

2018-08-15

Last updated by the study team

2020-02-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 — Gradiska, 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
• Clinical and Translational Research Center of Alabama, PC — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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