A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Pfizer
Study ID
NCT02480153
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-06410293 — BIOLOGICAL
    PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
  • Adalimumab — BIOLOGICAL
    Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

Study Details

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

Key Dates

Start date
Jun 25, 2015
Status verified
Jan 2019
Primary completion
Aug 31, 2016
Completion
Dec 6, 2017

Study Design

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

Arms

  • Experimental: PF-06410293
  • Active Comparator: Adalimumab

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1 [ Time Frame: Week 12 ]

Locations (49)

FacilityCityStateZIPSite coordinators
ArthroCare, Arthritis Care & Research P.C.GilbertArizona85234-
Arizona Arthritis & Rheumatology Associates, PCGlendaleArizona85306-
Arizona Arthritis & Rheumatology Associates, PCPhoenixArizona85032-
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage HealthcareFullertonCalifornia92835-
East Bay Rheumatology Medical Group, Inc.San LeandroCalifornia94578-
Westlake Medical ResearchThousand OaksCalifornia91360-
Inland Rheumatology Clinical Trials, Inc.UplandCalifornia91786-
Desert Valley Medical GroupVictorvilleCalifornia92395-
Javed Rheumatology Associates, IncNewarkDelaware19713-
Arthritis and Rheumatic Disease SpecialtiesAventuraFlorida33180-
Robert W. Levin, MD, PAClearwaterFlorida33765-
International Medical ResearchDaytona BeachFlorida32117-
SIMED Arthritis CenterGainesvilleFlorida32607-
Southeastern Integrated Medical, PL, d/b/a Florida Medical ResearchGainesvilleFlorida32607-
Rheumatology Associates of Central Florida, P.A.OrlandoFlorida32806-
Sarasota Arthritis Research CenterSarasotaFlorida34239-
Alastair C. Kennedy, MDVero BeachFlorida32960-
Indian River Primary CareVero BeachFlorida32960-
St Luke's Intermountain Research CenterBoiseIdaho83702-
St Luke' s ClinicMeridianIdaho83642-
Physician's Clinic of Iowa, P.C.Cedar RapidsIowa52403-
Graves-Gilbert Clinic Bowling GreenBowling GreenKentucky42101-
The Center for Rheumatology and Bone ResearchWheatonMaryland20902-
Bronson Internal Medicine and RheumatologyBattle CreekMichigan49015-
North Mississippi Medical Clinics, Inc. - Clinical ResearchTupeloMississippi38801-
Physician Research Collaboration, LLCLincolnNebraska68516-
Westroads Clinical Research, Inc.OmahaNebraska68114-
Arthritis, Rheumatic & Back Disease Associates, P.A.Voorhees TownshipNew Jersey08043-
Manhattan Medical ResearchNew YorkNew York10016-
Buffalo Rheumatology and Medicine PLLCOrchard ParkNew York14127-
Physicians East PAGreenvilleNorth Carolina27834-
Cincinnati Rheumatic Disease Study Group, Inc.CincinnatiOhio45242-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Clinical Research of Reading, LLCWyomissingPennsylvania19610-
Low Country Rheumatology, PACharlestonSouth Carolina29406-
Regional Health Clinical ResearchRapid CitySouth Dakota57701-
Regional Medical Clinic - RheumatologyRapid CitySouth Dakota57701-
West Tennessee Research InstituteJacksonTennessee38305-
Ramesh C Gupta, M.D.MemphisTennessee38119-
Amarillo Center for Clinical Research, Ltd.AmarilloTexas79124-
Austin Regional ClinicAustinTexas78731-
Metroplex Clinical Research CenterDallasTexas75231-
The Clinical Research Institute of Houston, LLCHoustonTexas77090-
Accurate Clinical ResearchLeague CityTexas77573-
Southwest Rheumatology Research, LLCMesquiteTexas75150-
Northwest Diagnostic Clinic, PAShenandoahTexas77380-
Center for Arthritis and Rheumatic Diseases, P.C.ChesapeakeVirginia23320-
Wenatchee Valley Hospitals & ClinicsWenatcheeWashington98801-
Rheumatology and Pulmonary ClinicBeckleyWest Virginia25801-

Find similar trials in Gilbert, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
ArthroCare, Arthritis Care & Research P.C.· Gilbert, AZArizona Arthritis & Rheumatology Associates, PC· Glendale, AZArizona Arthritis & Rheumatology Associates, PC· Phoenix, AZSt. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare· Fullerton, CAEast Bay Rheumatology Medical Group, Inc.· San Leandro, CAWestlake Medical Research· Thousand Oaks, CA

Related Studies