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

This study has been completed.
Sponsor:
Collaborators:
Scientific Research Institute of Rheumatology, Moscow
Almedis
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01163916
First received: February 26, 2010
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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.


Condition
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Characteristics of Patients Prescribed Adalimumab: Education Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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: Occupation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants were asked to indicate their occupation at the Baseline visit.

  • Characteristics of Patients Prescribed Adalimumab: Residence Status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.

  • Characteristics of Patients Prescribed Adalimumab: Marital Status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants were asked to indicate their marital status at the Baseline visit.

  • Characteristics of Patients Prescribed Adalimumab: Disease Severity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.

  • Characteristics of Patients Prescribed Adalimumab: Duration of Disease [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Duration of disease was defined as the time from diagnosis until study entry.

  • 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). ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.


  • Percentage of Participants With Missed or Delayed Injections [ Time Frame: For the duration of the study (up to a maximum of 18.2 months). ] [ Designated as safety issue: No ]
    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 [ Time Frame: For the duration of the study (up to a maximum of 18.2 months). ] [ Designated as safety issue: No ]
    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.


Enrollment: 252
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163916

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01163916     History of Changes
Other Study ID Numbers: P10-272
Study First Received: February 26, 2010
Results First Received: November 8, 2012
Last Updated: December 5, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Abbott:
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 14, 2014