NCT01078090

Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,745 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.

Detailed description

Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.

Conditions

• Rheumatoid Arthritis

Timeline

• Start date: 2003-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-03-02
• Last updated: 2014-05-08
• Results posted: 2014-04-23

Locations

370 sites across 1 country: Germany