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

December 5, 2012 updated by: Abbott

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.

Study Overview

Status

Completed

Conditions

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, 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 Type

Observational

Enrollment (Actual)

252

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Belgorod, Russian Federation, 308007
        • Site Ref # / Investigator 50728
      • Chelyabinsk, Russian Federation, 454047
        • Site Ref # / Investigator 50737
      • Ekaterinburg, Russian Federation, 620000
        • Site Reference ID/Investigator# 6002
      • Izhevsk, Russian Federation, 426009
        • Site Ref # / Investigator 50731
      • Kaliningrad, Russian Federation, 236000
        • Site Reference ID/Investigator# 29084
      • Khanty Mansisk, Russian Federation, 628600
        • Site Ref # / Investigator 50746
      • Khanty-Mansiysk, Russian Federation, 626200
        • Site Reference ID/Investigator# 29163
      • Krasnogorsk, Russian Federation, 143420
        • Site Ref # / Investigator 50736
      • Lipetsk, Russian Federation, 308036
        • Site Ref # / Investigator 50727
      • Moscow, Russian Federation, 105203
        • Site Ref # / Investigator 50723
      • Moscow, Russian Federation, 105229
        • Site Ref # / Investigator 50725
      • Moscow, Russian Federation, 109451
        • Site Ref # / Investigator 50742
      • Moscow, Russian Federation, 109451
        • Site Ref # / Investigator 50743
      • Moscow, Russian Federation, 115682
        • Site Ref # / Investigator 50724
      • Moscow, Russian Federation, 121356
        • Site Ref # / Investigator 50739
      • Moscow, Russian Federation, 123060
        • Site Ref # / Investigator 50732
      • Moscow, Russian Federation, 123098
        • Site Ref # / Investigator 50738
      • Moscow, Russian Federation, 123308
        • Site Ref # / Investigator 50744
      • Moscow, Russian Federation, 125009
        • Site Reference ID/Investigator# 28989
      • Moscow, Russian Federation, 125009
        • Site Reference ID/Investigator# 28990
      • Moscow, Russian Federation, 125009
        • Site Reference ID/Investigator# 29195
      • Moscow, Russian Federation, 125009
        • Site Reference ID/Investigator# 29482
      • Moscow, Russian Federation, 125009
        • Site Reference ID/Investigator# 29483
      • Moscow, Russian Federation, 127206
        • Site Ref # / Investigator 50740
      • Moscow, Russian Federation, 127473
        • Site Ref # / Investigator 50733
      • Moscow, Russian Federation, 127543
        • Site Ref # / Investigator 50745
      • Moscow, Russian Federation, 127642
        • Site Ref # / Investigator 50741
      • Nizhnevartovsk, Russian Federation, 628600
        • Site Reference ID/Investigator# 28956
      • Perm, Russian Federation, 614014
        • Site Reference ID/Investigator# 28968
      • Perm, Russian Federation, 614014
        • Site Reference ID/Investigator# 28969
      • Saint Petersburg, Russian Federation, 191015
        • Site Reference ID/Investigator# 32403
      • Salekhard, Russian Federation, 629001
        • Site Ref # / Investigator 50729
      • St. Petersburg, Russian Federation, 190000
        • Site Reference ID/Investigator# 28957
      • St. Petersburg, Russian Federation, 190000
        • Site Reference ID/Investigator# 28997
      • St. Petersburg, Russian Federation, 190000
        • Site Reference ID/Investigator# 28999
      • St. Petersburg, Russian Federation, 190000
        • Site Reference ID/Investigator# 29001
      • Surgut, Russian Federation, 628400
        • Site Reference ID/Investigator# 29008
      • Tula, Russian Federation, 300036
        • Site Reference ID/Investigator# 32404
      • Ulyanovsk, Russian Federation, 432000
        • Site Reference ID/Investigator# 29095
      • V. Novgorod, Russian Federation, 173008
        • Site Ref # / Investigator 50734
      • Vologda, Russian Federation, 160001
        • Site Ref # / Investigator 50730
      • Voronezh, Russian Federation, 394024
        • Site Ref # / Investigator 50735
      • Voronezh, Russian Federation, 394082
        • Site Ref # / Investigator 50726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of Patients Prescribed Adalimumab: Education Level
Time Frame: Baseline
Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.
Baseline
Characteristics of Patients Prescribed Adalimumab: Occupation
Time Frame: Baseline
Participants were asked to indicate their occupation at the Baseline visit.
Baseline
Characteristics of Patients Prescribed Adalimumab: Residence Status
Time Frame: Baseline
Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Baseline
Characteristics of Patients Prescribed Adalimumab: Marital Status
Time Frame: Baseline
Participants were asked to indicate their marital status at the Baseline visit.
Baseline
Characteristics of Patients Prescribed Adalimumab: Disease Severity
Time Frame: Baseline
Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Baseline
Characteristics of Patients Prescribed Adalimumab: Duration of Disease
Time Frame: Baseline
Duration of disease was defined as the time from diagnosis until study entry.
Baseline
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
Time Frame: Baseline and at each follow-up visit (up to a maximum of 18.2 months).
Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.
Baseline and at each follow-up visit (up to a maximum of 18.2 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's Acceptability of Self-injections
Time Frame: Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.

At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were "convenient," "inconvenient" and "unable to self-inject."

The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.

Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization.
Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.
Percentage of Participants With Missed or Delayed Injections
Time Frame: For the duration of the study (up to a maximum of 18.2 months).
Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.
For the duration of the study (up to a maximum of 18.2 months).
Duration of Treatment With Adalimumab
Time Frame: For the duration of the study (up to a maximum of 18.2 months).
Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.
For the duration of the study (up to a maximum of 18.2 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Almedis
Scientific Research Institute of Rheumatology, Moscow

Investigators

  • Study Director: Andrey N Strugovschikov, MD, Abbott Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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