Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Amgen
Study ID
NCT01307423
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Key Dates

First listed
Mar 2, 2011
Start date
Dec 9, 2010
Status verified
Apr 2020
Primary completion
Feb 21, 2013
Completion
Aug 16, 2017

Study Design

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

Arms

  • Experimental: Apremilast 20mg
    Apremilast 20mg twice daily, orally
  • Experimental: Apremilast 30mg
    Apremilast 30mg twice daily, orally
  • Placebo Comparator: Placebo + 20mg Apremilast
    Placebo + 20mg Apremilast tablets administered twice daily
  • Placebo Comparator: Placebo + 30mg Apremilast
    Placebo + 30mg Apremilast tablets administered twice daily

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16 [ Time Frame: Baseline and Week 16 ]

Locations (30)

FacilityCityStateZIPSite coordinators
Arizona Research CenterPhoenixArizona85023-
Desert Medical AdvancesPalm DesertCalifornia92260-
In Vivo Clinical ResearchDoralFlorida33166-
Centre For Rheumatology, Immun. And ArthritisFort LauderdaleFlorida33334-
North Florida DermatologyJacksonvilleFlorida32204-
Florida Center for Dermatology, PASaint AugustineFlorida32086-
Tampa Medical Group PaTampaFlorida33614-
Atlanta Dermatology, Vein and Research Center, PCAlpharettaGeorgia30022-
Arthritis and Rheumatology of GeorgiaAtlantaGeorgia30342-
Sonora Clinical Research, LLCBoiseIdaho83702-
Rockford Orthopedic Associates, LLCRockfordIllinois61107-
The Arthritis CenterSpringfieldIllinois62704-
Indiana. UniversityIndianapolisIndiana46202-
Klein and Associates MD, PACumberlandMaryland21502-
Klein and Associates MD, PAHagerstownMaryland21740-
Clinical Pharmacology Study GroupWorcesterMassachusetts01605-
Justus Fiechtner MD PCLansingMichigan48910-
Heartland Clinical Research, Inc.OmahaNebraska68134-
Physicians EastGreenvilleNorth Carolina27834-
Unifour Medical Research Associatets LLCHickoryNorth Carolina28602-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Clinical Research Center of Reading, LLPWest ReadingPennsylvania19610-
West Tennessee Research InstituteJacksonTennessee38305-
Austin Regional ClinicAustinTexas78731-
Center for Clinical StudiesHoustonTexas77065-
Houston Medical ResearchHoustonTexas77090-
Luckster EnterprisesSan AntonioTexas78232-
Center for Clinical StudiesWebsterTexas77598-
Rheumatology and Immunotherapy CenterFranklinWisconsin53132-
PharmaSeekMiddletonWisconsin53562-

Find similar trials in Phoenix, AZ

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Arizona Research Center· Phoenix, AZDesert Medical Advances· Palm Desert, CAIn Vivo Clinical Research· Doral, FLCentre For Rheumatology, Immun. And Arthritis· Fort Lauderdale, FLNorth Florida Dermatology· Jacksonville, FLFlorida Center for Dermatology, PA· Saint Augustine, FL

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