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

Completed

Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis

Registration Number: NCT01163916

Lead Sponsor: Abbott

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; 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 252

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characteristics of Patients Prescribed Adalimumab: Disease Severity	Baseline	Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment	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.
Characteristics of Patients Prescribed Adalimumab: Occupation	Baseline	Participants were asked to indicate their occupation at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Residence Status	Baseline	Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Education Level	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.
Characteristics of Patients Prescribed Adalimumab: Marital Status	Baseline	Participants were asked to indicate their marital status at the Baseline visit.
Characteristics of Patients Prescribed Adalimumab: Duration of Disease	Baseline	Duration of disease was defined as the time from diagnosis until study entry.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Missed or Delayed Injections	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.
Duration of Treatment With Adalimumab	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.
Patient's Acceptability of Self-injections	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.

Trial Locations

Locations (43): Site Ref # / Investigator 50731
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Izhevsk, Russian Federation
Site Reference ID/Investigator# 29482
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Moscow, Russian Federation
Site Reference ID/Investigator# 29195
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Moscow, Russian Federation
Site Ref # / Investigator 50735
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Voronezh, Russian Federation
Site Reference ID/Investigator# 32403
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Saint Petersburg, Russian Federation
Site Ref # / Investigator 50728
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Belgorod, Russian Federation
Site Reference ID/Investigator# 28969
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Perm, Russian Federation
Site Reference ID/Investigator# 32404
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Tula, Russian Federation
Site Ref # / Investigator 50730
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Vologda, Russian Federation
Site Reference ID/Investigator# 28990
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Moscow, Russian Federation
Site Ref # / Investigator 50737
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Chelyabinsk, Russian Federation
Site Reference ID/Investigator# 29163
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Khanty-Mansiysk, Russian Federation
Site Ref # / Investigator 50723
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Moscow, Russian Federation
Site Ref # / Investigator 50743
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Moscow, Russian Federation
Site Ref # / Investigator 50746
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Khanty Mansisk, Russian Federation
Site Ref # / Investigator 50736
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Krasnogorsk, Russian Federation
Site Ref # / Investigator 50727
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Lipetsk, Russian Federation
Site Reference ID/Investigator# 28968
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Perm, Russian Federation
Site Ref # / Investigator 50725
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Moscow, Russian Federation
Site Ref # / Investigator 50742
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Moscow, Russian Federation
Site Ref # / Investigator 50739
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Moscow, Russian Federation
Site Reference ID/Investigator# 6002
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Ekaterinburg, Russian Federation
Site Reference ID/Investigator# 29084
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Kaliningrad, Russian Federation
Site Ref # / Investigator 50724
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Moscow, Russian Federation
Site Ref # / Investigator 50732
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Moscow, Russian Federation
Site Ref # / Investigator 50733
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Moscow, Russian Federation
Site Ref # / Investigator 50738
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Moscow, Russian Federation
Site Ref # / Investigator 50744
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Moscow, Russian Federation
Site Reference ID/Investigator# 29483
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Moscow, Russian Federation
Site Ref # / Investigator 50745
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Moscow, Russian Federation
Site Ref # / Investigator 50740
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Moscow, Russian Federation
Site Reference ID/Investigator# 28956
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Nizhnevartovsk, Russian Federation
Site Reference ID/Investigator# 29001
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 29008
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Surgut, Russian Federation
Site Ref # / Investigator 50729
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Salekhard, Russian Federation
Site Reference ID/Investigator# 28957
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 28997
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 28999
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 29095
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Ulyanovsk, Russian Federation
Site Ref # / Investigator 50734
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V. Novgorod, Russian Federation
Site Ref # / Investigator 50726
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Voronezh, Russian Federation
Site Reference ID/Investigator# 28989
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Moscow, Russian Federation
Site Ref # / Investigator 50741
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Moscow, Russian Federation