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Completed

NCT Number: 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

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.

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Key information

Conditions

Rheumatoid Arthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Ref # / Investigator 50728, Belgorod, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Characteristics of Patients Prescribed Adalimumab: Occupation

    Time frame: Baseline

    Participants were asked to indicate their occupation at the Baseline visit.

  3. 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.

  4. Characteristics of Patients Prescribed Adalimumab: Marital Status

    Time frame: Baseline

    Participants were asked to indicate their marital status at the Baseline visit.

  5. 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.

  6. Characteristics of Patients Prescribed Adalimumab: Duration of Disease

    Time frame: Baseline

    Duration of disease was defined as the time from diagnosis until study entry.

  7. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Almedis
  • Scientific Research Institute of Rheumatology, Moscow

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 16, 2010
Registry last updated
Dec 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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