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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with RA, PsA and AS<br>Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) prescribed adalimumab as part of Routine Clinical Care in Russia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of Patients Prescribed Adalimumab: Education Level | 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. | Baseline | 
| Characteristics of Patients Prescribed Adalimumab: Occupation | Participants were asked to indicate their occupation at the Baseline visit. | Baseline | 
| Characteristics of Patients Prescribed Adalimumab: Residence Status | Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit. | Baseline | 
| Characteristics of Patients Prescribed Adalimumab: Marital Status | Participants were asked to indicate their marital status at the Baseline visit. | Baseline | 
| Characteristics of Patients Prescribed Adalimumab: Disease Severity | Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice. | Baseline | 
| Characteristics of Patients Prescribed Adalimumab: Duration of Disease | Duration of disease was defined as the time from diagnosis until study entry. | Baseline | 
| Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | 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. | Baseline and at each follow-up visit (up to a maximum of 18.2 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Acceptability of Self-injections | 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. | 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. | 
| Percentage of Participants With Missed or Delayed Injections | Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days. | For the duration of the study (up to a maximum of 18.2 months). | 
| Duration of Treatment With Adalimumab | 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. | For the duration of the study (up to a maximum of 18.2 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis