NCT01712178

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

Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab, current formulation	Current formulation adalimumab 40 mg every other week
BIOLOGICAL	Adalimumab, new formulation	New formulation adalimumab 40 mg every other week

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-10-23
• Last updated: 2014-06-11
• Results posted: 2014-06-11

Locations

21 sites across 7 countries: United States, Belgium, Czechia, Germany, Puerto Rico, Romania, Slovakia