Status:
COMPLETED
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
Lead Sponsor:
Abbott
Collaborating Sponsors:
Scientific Research Institute of Rheumatology, Moscow
Almedis
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Brief 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;...
Detailed 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, populati...
Eligibility Criteria
Inclusion
- Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria:
- Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history.
- Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
Exclusion
- The following patients will not be included in the study:
- Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab.
- Hypersensitivity to adalimumab
- Pregnancy
- Lactation
- Age below 18
- Infectious diseases including tuberculosis
- Patients currently participating in another clinical trial.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT01163916
Start Date
January 1 2008
End Date
November 1 2011
Last Update
December 7 2012
Active Locations (43)
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1
Site Ref # / Investigator 50728
Belgorod, Russia, 308007
2
Site Ref # / Investigator 50737
Chelyabinsk, Russia, 454047
3
Site Ref # / Investigator 50731
Izhevsk, Russia, 426009
4
Site Reference ID/Investigator# 29084
Kaliningrad, Russia, 236000