Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00796705
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — DRUG
    40 mg injection of adalimumab administered subcutaneously
  • Adalimumab placebo — DRUG
    1.0 ml .9% saline placebo administered subcutaneously
  • Etanercept — DRUG
    50 mg dimeric fusion protein administered subcutaneously

Study Details

Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.

Key Dates

Start date
Nov 30, 2008
Status verified
Aug 2012
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

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

Arms

  • Experimental: Adalimumab / Adalimumab Placebo
    1 sub-cutaneous (SQ) injection of adalimumab or 1 SQ injection of placebo will be given in a blinded and alternating fashion for a total of 12 weeks
  • Experimental: Etanercept
    Participants will receive 1 SQ injection of etanercept each week for 12 weeks

Primary Outcome Measure

Change in the Disease Activity Score Using C-reactive Protein (DAS28[CRP]) From Baseline to Week 12 in Non-Switchers Versus Switchers. [ Time Frame: Baseline, Week 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
Stanford UniversityPalo AltoCalifornia94304-
Yale New Haven HospitalNew HavenConnecticut06520-
Sarasota Arthritis Research CenterSarasotaFlorida34239-
Tampa Medical GroupTampaFlorida33614-
University of Chicago Medical CenterChicagoIllinois60637-
Justus Fiechtner, MD, PCLansingMichigan48910-
Feinstein Institute for Medical Research NS-LIJManhassettNew York14642-
University of RochesterRochesterNew York14642-
Carolina Bone and JointCharlotteNorth Carolina28210-
Duke University Medical CenterDurhamNorth Carolina27710-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
University of PittsburghPittsburghPennsylvania15260-
Baylor Research InstituteDallasTexas75231-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Alabama· Birmingham, ALStanford University· Palo Alto, CAYale New Haven Hospital· New Haven, CTSarasota Arthritis Research Center· Sarasota, FLTampa Medical Group· Tampa, FLUniversity of Chicago Medical Center· Chicago, IL

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