Clinical trial 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Keywords: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Scientific Research Institute of Rheumatology, Moscow
name: Almedis
First posted: 2010-07-16
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characteristics of Patients Prescribed Adalimumab: Education Level
timeFrame: Baseline
measure: Characteristics of Patients Prescribed Adalimumab: Occupation
timeFrame: Baseline
measure: Characteristics of Patients Prescribed Adalimumab: Residence Status
timeFrame: Baseline
measure: Characteristics of Patients Prescribed Adalimumab: Marital Status
timeFrame: Baseline
measure: Characteristics of Patients Prescribed Adalimumab: Disease Severity
timeFrame: Baseline
measure: Characteristics of Patients Prescribed Adalimumab: Duration of Disease
timeFrame: Baseline
measure: Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
timeFrame: Baseline and at each follow-up visit (up to a maximum of 18.2 months).
Secondary outcomes:
measure: Patient's Acceptability of Self-injections
timeFrame: 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.
measure: Percentage of Participants With Missed or Delayed Injections
timeFrame: For the duration of the study (up to a maximum of 18.2 months).
measure: Duration of Treatment With Adalimumab
timeFrame: For the duration of the study (up to a maximum of 18.2 months).
Other outcomes:
Locations:
city: Belgorod
country: Russian Federation
facility: Site Ref # / Investigator 50728
city: Chelyabinsk
country: Russian Federation
facility: Site Ref # / Investigator 50737
city: Ekaterinburg
country: Russian Federation
facility: Site Reference ID/Investigator# 6002
city: Izhevsk
country: Russian Federation
facility: Site Ref # / Investigator 50731
city: Kaliningrad
country: Russian Federation
facility: Site Reference ID/Investigator# 29084
city: Khanty Mansisk
country: Russian Federation
facility: Site Ref # / Investigator 50746
city: Khanty-Mansiysk
country: Russian Federation
facility: Site Reference ID/Investigator# 29163
city: Krasnogorsk
country: Russian Federation
facility: Site Ref # / Investigator 50736
city: Lipetsk
country: Russian Federation
facility: Site Ref # / Investigator 50727
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50723
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50725
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50742
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50743
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50724
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50739
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50732
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50738
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50744
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 28989
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 28990
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 29195
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 29482
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 29483
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50740
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50733
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50745
city: Moscow
country: Russian Federation
facility: Site Ref # / Investigator 50741
city: Nizhnevartovsk
country: Russian Federation
facility: Site Reference ID/Investigator# 28956
city: Perm
country: Russian Federation
facility: Site Reference ID/Investigator# 28968
city: Perm
country: Russian Federation
facility: Site Reference ID/Investigator# 28969
city: Saint Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 32403
city: Salekhard
country: Russian Federation
facility: Site Ref # / Investigator 50729
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 28957
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 28997
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 28999
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 29001
city: Surgut
country: Russian Federation
facility: Site Reference ID/Investigator# 29008
city: Tula
country: Russian Federation
facility: Site Reference ID/Investigator# 32404
city: Ulyanovsk
country: Russian Federation
facility: Site Reference ID/Investigator# 29095
city: V. Novgorod
country: Russian Federation
facility: Site Ref # / Investigator 50734
city: Vologda
country: Russian Federation
facility: Site Ref # / Investigator 50730
city: Voronezh
country: Russian Federation
facility: Site Ref # / Investigator 50735
city: Voronezh
country: Russian Federation
facility: Site Ref # / Investigator 50726
Study officials:
affiliation: Abbott Russia
name: Andrey N Strugovschikov, MD
role: STUDY_DIRECTOR
References: