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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

2014-07-23 21:08:07 | BioPortfolio

Summary

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

Description

Primary objective The primary objective of this post-marketing observational study is to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history, including DMARDs/BDMARDs; current concomitant medications; other relevant medical history, including TB (prior diagnosis/effectiveness of treatment; screening and prophylaxis history) of patients prescribed HUMIRA (adalimumab) for RA/AS/PsA as part of routine clinical care.

Acronyms used:

- disease-modifying antirheumatic drugs (DMARDs)

- biological disease-modifying antirheumatic drugs (bDMARDs)

- rheumatoid arthritis (RA)

- ankylosing spondylitis (AS)

- psoriatic arthritis (PsA)

- tuberculosis (TB)

Secondary objectives

- Patient acceptability of self-injection and compliance with therapy

- Clinical tolerability and safety

Study Design

Time Perspective: Prospective

Conditions

Rheumatoid Arthritis

Location

Site Reference ID/Investigator# 6002
Ekaterinburg
Russian Federation
620000

Status

Recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:07-0400

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