Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Scientific Affairs, LLC
Study ID
NCT02728934
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Golimumab Intravenous (IV) — BIOLOGICAL
    This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
  • Infliximab — BIOLOGICAL
    This is an observational study. Patients who will receive infliximab will be observed for 3 years.
  • Biosimilar Infliximab — BIOLOGICAL
    This is an observational study. New patients who will receive biosimilar infliximab will be observed for 3 years (maximum). Biosimilar Infliximab patients will be included in Exploratory analyses only and will not be included in Primary or Secondary outcome measures analyses.

Study Details

The purpose of this study is to compare the proportion of patients with an infusion reaction in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.

Key Dates

Start date
Feb 25, 2016
Status verified
Apr 2020
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020

Study Design

Enrollment
1,279 participants (actual)

Arms

  • Arm: Golimumab Intravenous (IV)
    Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Golimumab IV.
  • Arm: Infliximab
    Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Infliximab.

Primary Outcome Measure

Proportion of Patients With an Infusion Reaction Through Week 52 [ Time Frame: Up to week 52 ]

Locations (85)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-HuntsvilleAlabama--
-GlendaleArizona--
-MesaArizona--
-PeoriaArizona--
-PhoenixArizona--
-PrescottArizona--
-Sun CityArizona--
-BakersfieldCalifornia--
-CampbellCalifornia--
-CovinaCalifornia--
-El CajonCalifornia--
-HemetCalifornia--
-Los AngelesCalifornia--
-Santa CruzCalifornia--
-Thousand OaksCalifornia--
-UplandCalifornia--
-Van NuysCalifornia--
-West HillsCalifornia--
-WhittierCalifornia--
-DenverColorado--
-LakewoodColorado--
-ClearwaterFlorida--
-Palm HarborFlorida--
-PlantationFlorida--
-TamaracFlorida--
-VeniceFlorida--
-LawrencevilleGeorgia--
-SpringfieldIllinois--
-MuncieIndiana--
-Bowling GreenKentucky--
-Baton RougeLouisiana--
-MonroeLouisiana--
-ShreveportLouisiana--
-CumberlandMaryland--
-HagerstownMaryland--
-TowsonMaryland--
-WheatonMaryland--
-Ann ArborMichigan--
-LansingMichigan--
-Saint Clair ShoresMichigan--
-EaganMinnesota--
-EdinaMinnesota--
-Las VegasNevada--
-NashuaNew Hampshire--
-FreeholdNew Jersey--
-Voorhees TownshipNew Jersey--
-BrooklynNew York--
-Orchard ParkNew York--
-GreensboroNorth Carolina--
-LelandNorth Carolina--
-RaleighNorth Carolina--
-Winston-SalemNorth Carolina--
-EdmondOklahoma--
-TulsaOklahoma--
-BethlehemPennsylvania--
-DuncansvillePennsylvania--
-PhiladelphiaPennsylvania--
-WexfordPennsylvania--
-Myrtle BeachSouth Carolina--
-NashvilleTennessee--
-AmarilloTexas--
-BeaumontTexas--
-College StationTexas--
-Corpus ChristiTexas--
-DallasTexas--
-HoustonTexas--
-LubbockTexas--
-MesquiteTexas--
-Nassau BayTexas--
-PlanoTexas--
-San AntonioTexas--
-San MarcosTexas--
-Sugar LandTexas--
-The WoodlandsTexas--
-WacoTexas--
-ArlingtonVirginia--
-ChesapeakeVirginia--
-Newport NewsVirginia--
-KennewickWashington--
-SeattleWashington--
-BeckleyWest Virginia--
-South CharlestonWest Virginia--
-GlendaleWisconsin--
-OnalaskaWisconsin--

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders

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