A Study to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation

Study Overview
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Brief Summary
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The objective of this study is to access retention rate, persistence and adherence in population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis (PsA)) participants treated with adalimumab in routine clinical settings in the Russian Federation.

Official Title
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Prospective, Multi-Center, Observational, Program to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation

Conditions
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Spondylarthritis, Psoriatic Arthritis, Ankylosing Spondylitis (AS)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of AS or PsA. Planned prescription or prescribed no more than 1 month before to enrolment therapy with adalimumab. Treatment has to be prescribed according to the local product label and prescription guidelines. At the moment of start of treatment with adalimumab moderate/severe AS or PsA (BASDAI > 4 for AS; DAS28 >3,2 for PsA). Negative result of tuberculosis (TB) screening test and TB specialist permission to start biologic therapy. Authorization (Consent) for Use/Disclosure of Data signed by the participant. Exclusion Criteria: Has contraindications for the treatment with adalimumab (please see the latest version of the locally approved label). Participants who are unable to walk and perform basic self-care activities either due to SpA or a comorbid condition. Any biologic drugs taken over before 3 months of enrolment to the study. Previous participation in this program.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Participants with Spondylarthritis<br>Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants on adalimumab therapy | This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in RA and SpA. | Up to 30 days after administering last dose in the study (52 weeks) | 
| Number of participants on adalimumab therapy | This is used to assess retention rate. Persistence/Adherence of SpA patient to treatment, as well as retention rate, is an important factor of achieving of treatment goals. Medical non-adherence poses a significant limitation to treating to target in rheumatoid arthritis (RA) and SpA. | Up to 30 days after administering last dose in the study (52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing medication persistence | Medication persistence is defined as the duration of time from initiation to discontinuation of therapy. | Up to 48 weeks of treatment period | 
| Assessing medication adherence | Medication adherence is defined as the extent to which a participant acts in accordance with the prescribed interval and dose of a dosing. | Up to 48 weeks of treatment period | 
| Change of disease activity in participants with PsA | This is assessed using Disease activity score 28 joints count (DAS28) in participants with PsA. | Up to 48 weeks of treatment period | 
| Change of disease activity in participants with AS | This is assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with AS. | Up to 48 weeks of treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adalimumab, Ankylosing spondylitis, Psoriatic arthritis, Spondylarthritis, Humira®