Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
Amgen
Study ID
NCT02792699
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ABP 798 — DRUG
    Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.
  • Rituximab (US) — DRUG
    Supplied as a 10 mg/mL liquid concentrate for IV administration.
  • Rituximab (EU) — DRUG
    Supplied as a 10 mg/mL liquid concentrate for IV administration.

Study Details

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe RA. This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Key Dates

Start date
May 17, 2016
Status verified
Oct 2020
Primary completion
Oct 8, 2018
Completion
Oct 8, 2018

Study Design

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

Arms

  • Experimental: ABP 798 / ABP 798
    Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
  • Active Comparator: Rituximab (US) / ABP 798
    Participants received rituximab (United States \[US\] formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
  • Active Comparator: Rituximab (EU) / Rituximab (EU)
    Participants received rituximab (European Union \[EU\] formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.

Primary Outcome Measure

Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose [ Time Frame: Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose. ]

Locations (27)

FacilityCityStateZIPSite coordinators
Research SiteTuscaloosaAlabama35406-
Research SiteLos AngelesCalifornia90095-1670-
Research SiteThousand OaksCalifornia91360-
Research SiteUplandCalifornia91786-
Research SiteAventuraFlorida33180-
Research SiteEdgewaterFlorida32132-
Research SiteHialeahFlorida33012-
Research SiteOrlandoFlorida32810-
Research SiteVero BeachFlorida32960-
Research SiteIdaho FallsIdaho83404-
Research SiteLexingtonKentucky40504-
Research SiteLansingMichigan48910-
Research SiteFlowoodMississippi39232-
Research SiteLas VegasNevada89128-
Research SiteCharlotteNorth Carolina28210-
Research SiteOklahoma CityOklahoma73112-
Research SiteDuncansvillePennsylvania16635-
Research SiteOrangeburgSouth Carolina29118-
Research SiteSummervilleSouth Carolina29486-
Research SiteMemphisTennessee38119-
Research SiteCarrolltonTexas75007-1601-
Research SiteDallasTexas75231-
Research SiteLeague CityTexas77573-
Research SiteMesquiteTexas75150-
Research SitePlanoTexas75024-
Research SiteOlympiaWashington98502-
Research SiteSpokaneWashington99204-

Find similar trials in Tuscaloosa, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Research Site· Tuscaloosa, ALResearch Site· Los Angeles, CAResearch Site· Thousand Oaks, CAResearch Site· Upland, CAResearch Site· Aventura, FLResearch Site· Edgewater, FL

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