Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02745080
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab — BIOLOGICAL
    Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
  • Adalimumab — BIOLOGICAL
    Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Study Details

This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

Key Dates

Start date
Apr 3, 2017
Status verified
Jan 2021
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019

Study Design

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

Arms

  • Experimental: Secukinumab 300 mg s.c.
    Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
  • Active Comparator: Adalimumab 40 mg s.c.
    Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.

Primary Outcome Measure

Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 [ Time Frame: Week 52 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteFountain ValleyCalifornia92708-
Novartis Investigative SiteFullertonCalifornia92835-
Novartis Investigative SiteLa MesaCalifornia91942-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SiteBowling GreenKentucky42101-
Novartis Investigative SiteSt LouisMissouri63117-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteOmahaNebraska68114-
Novartis Investigative SiteRochesterNew York14623-
Novartis Investigative SiteBethlehemPennsylvania18015-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteArlingtonTexas76011-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteDallasTexas75231-
Novartis Investigative SiteMesquiteTexas75150-
Novartis Investigative SiteBurlingtonVermont05401-
Novartis Investigative SiteSeattleWashington98122-
Novartis Investigative SiteSpokaneWashington99204-
Novartis Investigative SiteGlendaleWisconsin53217-

Find similar trials in Fountain Valley, CA

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Novartis Investigative Site· Fountain Valley, CANovartis Investigative Site· Fullerton, CANovartis Investigative Site· La Mesa, CANovartis Investigative Site· Upland, CANovartis Investigative Site· Bowling Green, KYNovartis Investigative Site· St Louis, MO

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