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

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
Pfizer
Study ID
NCT02996500
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PF-06650833 — DRUG
    Investigational
  • Placebo — DRUG
    Placebo
  • Tofacitinib — DRUG
    Investigational

Study Details

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 Dates

Start date
Nov 10, 2016
Status verified
Feb 2020
Primary completion
Aug 15, 2018
Completion
Aug 15, 2018

Study Design

Enrollment
269 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: 20 mg QD
    PF-06650833 , 20 mg QD
  • Experimental: Arm 2: 60 mg QD
    PF-06650833, 60 mg QD
  • Experimental: Arm 3: 200 mg QD
    Pf-06650833, 200 mg QD
  • Experimental: Arm 4: 400 mg QD
    PF-06650833, 400 mg QD
  • Placebo Comparator: Placebo
    Placebo, 0 mg BID
  • Active Comparator: Arm 5: Tofacitinib
    Tofacitinib 5 mg BID

Primary Outcome Measure

Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Clinical and Translational Research Center of Alabama, PCTuscaloosaAlabama35406-
Dory Hardy, PharmDTucsonArizona85723-
Southern Arizona VA Health care SystemTucsonArizona85723-
Robert W. Levin, MD,PAClearwaterFlorida33765-
Millennium ResearchOrmond BeachFlorida32174-
Arthritis & Rheumatic Care CenterSouth MiamiFlorida33143-
Qps-Mra, LlcSouth MiamiFlorida33143-
Medical Associates of North GeorgiaCantonGeorgia30115-
Graves Gilbert ClinicBowling GreenKentucky42101-
Arthritis and Diabetes Clinic, Inc.MonroeLouisiana71203-
Ramesh C Gupta, M.D.MemphisTennessee38119-
Accurate Clinical Management, LLCBaytownTexas77521-
Accurate Clinical Management, LLCHoustonTexas77004-
Accurate Clinical Management, LLCHoustonTexas77084-
DM Clinical ResearchTomballTexas77375-

Find similar trials in Tuscaloosa, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Clinical and Translational Research Center of Alabama, PC· Tuscaloosa, ALDory Hardy, PharmD· Tucson, AZSouthern Arizona VA Health care System· Tucson, AZRobert W. Levin, MD,PA· Clearwater, FLMillennium Research· Ormond Beach, FLArthritis & Rheumatic Care Center· South Miami, FL

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