Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

Part of paid clinical trials in Victorville, California.

Sponsor
Amgen
Study ID
NCT01970475
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ABP 501 — BIOLOGICAL
    Solution for subcutaneous injection in pre-filled syringe
  • Adalimumab — BIOLOGICAL
    Solution for subcutaneous injection in pre-filled syringe

Study Details

The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).

Key Dates

Start date
Oct 31, 2013
Status verified
Oct 2016
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: ABP 501
    Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
  • Active Comparator: Adalimumab
    Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteVictorvilleCalifornia92395-
Research SiteJupiterFlorida33458-
Research SiteSandy SpringsGeorgia30328-
Research SiteLansingMichigan48910-
Research SiteMiddleburg HeightsOhio44130-

Find similar trials in Victorville, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Research Site· Victorville, CAResearch Site· Jupiter, FLResearch Site· Sandy Springs, GAResearch Site· Lansing, MIResearch Site· Middleburg Heights, OH

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