Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Abbott
Study ID
NCT00647270
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — DRUG
    Pre-filled syringe. See arm for more detail
  • Placebo — DRUG
    Pre-filled syringe. See arm for more detail
  • adalimumab — DRUG
    Pre-filled syringe. See arm for more detail

Study Details

To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

Key Dates

Start date
Dec 31, 2007
Status verified
Apr 2011
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo 12 weeks, 40mg adalimumab remaining 12 weeks
  • Active Comparator: 40 mg
    40 mg every other week
  • Active Comparator: 80 mg
    80 mg monthly

Primary Outcome Measure

The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow) [ Time Frame: Week 12 ]

Locations (48)

FacilityCityStateZIPSite coordinators
-HuntsvilleAlabama35801-
-TuscaloosaAlabama35406-
-Paradise ValleyArizona85253-
-HemetCalifornia92543-
-Long BeachCalifornia90806-
-Santa MonicaCalifornia90404-
-TorranceCalifornia90505-
-VictorvilleCalifornia92395-
-West HillsCalifornia91307-
-Wheat RidgeColorado80033-
-AventuraFlorida33180-
-Orange ParkFlorida32073-
-Palm HarborFlorida34684-
-SarasotaFlorida34239-
-TampaFlorida33614-
-Vero BeachFlorida32960-
-AtlantaGeorgia30342-
-ChicagoIllinois60612-
-MolineIllinois61201-
-SpringfieldIllinois62704-
-WichitaKansas67203-
-LexingtonKentucky40515-
-CovingtonLouisiana70433-
-BrightonMichigan48116-
-PassaicNew Jersey07055-
-SmithtownNew York11787-
-The BronxNew York10461-
-AshvilleNorth Carolina28801-
-CharlotteNorth Carolina28209-
-HickoryNorth Carolina28601-
-MonroeNorth Carolina28112-
-Oklahoma CityOklahoma73112-
-BendOregon97701-
-BethlehemPennsylvania18015-
-DuncansvillePennsylvania16635-
-PhiladelphiaPennsylvania19152-
-West ReadingPennsylvania19611-
-CharlestonSouth Carolina29406-
-GreenvilleSouth Carolina29601-
-JacksonTennessee38305-
-NashvilleTennessee37205-
-DallasTexas75235-
-HoustonTexas77034-
-HoustonTexas77074-
-San AntonioTexas78217-
-OgdenUtah84405-
-OlympiaWashington98502-
-GlendaleWisconsin53217-

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