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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

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ClinicalTrials.gov Identifier: NCT01163916
Recruitment Status : Completed
First Posted : July 16, 2010
Results First Posted : December 5, 2012
Last Update Posted : December 7, 2012
Sponsor:
Collaborators:
Scientific Research Institute of Rheumatology, Moscow
Almedis
Information provided by (Responsible Party):
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.

Condition or disease
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis

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.

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Study Type : Observational
Actual Enrollment : 252 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163916


Locations
Show Show 43 study locations
Sponsors and Collaborators
Abbott
Scientific Research Institute of Rheumatology, Moscow
Almedis
Investigators
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Study Director: Andrey N Strugovschikov, MD Abbott Russia

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01163916    
Other Study ID Numbers: P10-272
First Posted: July 16, 2010    Key Record Dates
Results First Posted: December 5, 2012
Last Update Posted: December 7, 2012
Last Verified: December 2012
Keywords provided by Abbott:
Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents