Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01561313
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)

Study Details

This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in two countries, Belgium (3 sites) and the Czech Republic (3 sites).

Key Dates

Start date
Mar 31, 2012
Status verified
Jan 2014
Primary completion
Nov 30, 2012
Completion
Nov 30, 2012

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Current formulation adalimumab
    One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
  • Experimental: New formulation of adalimumab
    One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe

Primary Outcome Measure

Mean Injection Site Pain on a Visual Analogue Scale (VAS) [ Time Frame: Immediately after injection ]

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