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NCT01163916

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

Last Updated: 2012-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis

Keywords

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Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with RA, PsA and AS

Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) prescribed adalimumab as part of Routine Clinical Care in Russia.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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 Criteria

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrey N Strugovschikov, MD

Role: STUDY_DIRECTOR

Abbott Russia

Review additional registry numbers or institutional identifiers associated with this trial.

P10-272

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Patients with RA, PsA and AS

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Scientific Research Institute of Rheumatology, Moscow

Almedis

Abbott

Responsible Party

Principal Investigators

Andrey N Strugovschikov, MD

Locations

Site Ref # / Investigator 50728

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Site Reference ID/Investigator# 29084

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Site Reference ID/Investigator# 6002

Countries

Other Identifiers

P10-272