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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Site Ref # / Investigator 50728
Belgorod, Russia
Site Ref # / Investigator 50737
Chelyabinsk, Russia
Site Ref # / Investigator 50731
Izhevsk, Russia
Site Reference ID/Investigator# 29084
Kaliningrad, Russia
Site Reference ID/Investigator# 29163
Khanty-Mansiysk, Russia
Site Ref # / Investigator 50746
Khanty-Mansiysk, Russia
Site Ref # / Investigator 50736
Krasnogorsk, Russia
Site Ref # / Investigator 50727
Lipetsk, Russia
Site Ref # / Investigator 50723
Moscow, Russia
Site Ref # / Investigator 50725
Moscow, Russia
Start Date
January 1, 2008
Primary Completion Date
November 1, 2011
Completion Date
November 1, 2011
Last Updated
December 7, 2012
252
ACTUAL participants
Lead Sponsor
Abbott
Collaborators
NCT07484243
NCT07295509
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06647069