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

Completed

Conditions: Ankylosing Spondylitis (AS)
Spondylarthritis
Psoriatic Arthritis

Brief Summary: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants on adalimumab therapy	Up to 30 days after administering last dose in the study (52 weeks)	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.
Number of participants on adalimumab therapy	Up to 30 days after administering last dose in the study (52 weeks)	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.

Secondary Outcome Measures

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

Locations (14): Institution KhMAO-Ugra /ID# 154381
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Khanty-mansiysk, Russian Federation
State Clinical Hospital /ID# 154373
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Moscow, Russian Federation
Research Institute of Rheum /ID# 154378
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Moscow, Russian Federation
GBUZ Republican Hospital /ID# 167029
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Petrozavodsk, Russian Federation
Ivanovo Regional Clinical Hosp /ID# 167028
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Ivanovo, Russian Federation
State Clinical policlinic /ID# 154374
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Moscow, Russian Federation
Nort-Western State Medical Uni /ID# 154376
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St. Petersburg, Russian Federation
Smolensk station JSC Russian R /ID# 167027
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Smolensk, Russian Federation
Tula Regional Clinical Hospita /ID# 155539
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Tula, Russian Federation
Central Research Institute /ID# 154375
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Moscow, Russian Federation
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379
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Moscow, Moskva, Russian Federation
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025
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Kemerovo, Kemerovskaya Oblast, Russian Federation
Yaroslavi State Medical Univer /ID# 154383
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Yaroslavl, Russian Federation
Advisory-diagnostic Hospital /ID# 154382
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Moscow, Russian Federation