A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01426789
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Matching placebo to secukinumab I.V.
  • Secukinumab — DRUG
    In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.

Study Details

This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.

Key Dates

Start date
Aug 31, 2011
Status verified
Aug 2015
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

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

Arms

  • Experimental: Secukinumab
    10 mg/kg intravenous (I.V.)
  • Placebo Comparator: Placebo
    Placebo I.V.

Primary Outcome Measure

Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group [ Time Frame: 12 weeks ]

Locations (16)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85023-
Novartis Investigative SiteTusconArizona85724-
Novartis Investigative SiteAnahiemCalifornia92804-
Novartis Investigative SiteClearwaterFlorida33756-
Novartis Investigative SiteCoral GablesFlorida33134-
Novartis Investigative SiteFleming IslandFlorida32003-
Novartis Investigative SiteMiamiFlorida33143-
Novartis Investigative SitePinellas ParkFlorida33781-
Novartis Investigative SiteVeniceFlorida34292-
Novartis Investigative SiteMariettaGeorgia30060-
Novartis Investigative SiteSouth BendIndiana46601-
Novartis Investigative SiteSpringfieldMissouri65807-
Novartis Investigative SiteAlbuquerqueNew Mexico87102-
Novartis Investigative SiteStatesvilleNorth Carolina28625-
Novartis Investigative SiteOklahoma CityOklahoma73112-
Novartis Investigative SiteSan AntonioTexas78217-

Find similar trials in Phoenix, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· Tuscon, AZNovartis Investigative Site· Anahiem, CANovartis Investigative Site· Clearwater, FLNovartis Investigative Site· Coral Gables, FLNovartis Investigative Site· Fleming Island, FL

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