A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety

Part of paid clinical trials in Mesa, Arizona.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01712178
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for pharmacodynamics, pharmacokinetics, and safety.

Key Dates

Start date
Jun 30, 2012
Status verified
Jun 2014
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

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

Arms

  • Experimental: New formulation of adalimumab 40 mg every other week
    New formulation adalimumab 40 mg every other week
  • Active Comparator: Current formulation adalimumab 40 mg every other week
    Current formulation adalimumab 40 mg every other week

Primary Outcome Measure

Serum Concentrations of Adalimumab at Weeks 12 and 24 [ Time Frame: Measured at Weeks 12 and 24 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 75073MesaArizona85202-
Site Reference ID/Investigator# 75077HemetCalifornia92543-
Site Reference ID/Investigator# 75076WichitaKansas67203-
Site Reference ID/Investigator# 75075CliftonNew Jersey07012-
Site Reference ID/Investigator# 83133PhiladelphiaPennsylvania19152-
Site Reference ID/Investigator# 75074CharlestonSouth Carolina29406-

Find similar trials in Mesa, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Site Reference ID/Investigator# 75073· Mesa, AZSite Reference ID/Investigator# 75077· Hemet, CASite Reference ID/Investigator# 75076· Wichita, KSSite Reference ID/Investigator# 75075· Clifton, NJSite Reference ID/Investigator# 83133· Philadelphia, PASite Reference ID/Investigator# 75074· Charleston, SC

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