NCT01502423

A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab

A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 three countries, Australia (3 sites), Canada (2 sites), and Germany (2 sites).

Detailed description

61 participants were randomized, and 60 received at least one dose of the study drug. One participant, who was randomized to the New formulation of adalimumab/Current formulation adalimumab arm of the study, discontinued from the study and never received study drug.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-12-30
• Last updated: 2014-02-20
• Results posted: 2014-02-20

Locations

7 sites across 3 countries: Australia, Canada, Germany