Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care

Rheumatoid Arthritis Clinical Trial

Official title: A Multi-Center Post Marketing Observational Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed HUMIRA® (Adalimumab) as Part of Routine Clinical Care in Russia

Status Completed

Clinical Trial Summary

The primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.

Clinical Trial Description

This is a non-interventional, observational study in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exist that characterize patient types and adalimumab administration within the Russian population. Further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care.

The total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. However, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. Follow-up visits were designated sequential visit numbers (Visit 1-6), regardless of the time point at which they occurred. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

• NCT number: NCT01163916
• Study type: Observational
• Source: Abbott
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Completion date: November 2011