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

AbbVie139 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

139

Conditions

Spondylarthritis Psoriatic Arthritis Ankylosing Spondylitis (AS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (14)

Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025

Kemerovo, Kemerovo Oblast, Russia

Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379

Moscow, Moscow, Russia

Ivanovo Regional Clinical Hosp /ID# 167028

Ivanovo, Russia

Institution KhMAO-Ugra /ID# 154381

Khanty-Mansiysk, Russia

State Clinical policlinic /ID# 154374

Moscow, Russia

Central Research Institute /ID# 154375

Moscow, Russia

Research Institute of Rheum /ID# 154378

Moscow, Russia

Advisory-diagnostic Hospital /ID# 154382

Moscow, Russia

State Clinical Hospital /ID# 154373

Moscow, Russia

GBUZ Republican Hospital /ID# 167029

Petrozavodsk, Russia

...and 4 more locations

Outcomes

Primary Outcomes

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.

Time frame: Up to 30 days after administering last dose in the study (52 weeks)

Number of participants on adalimumab therapy

Time frame: Up to 30 days after administering last dose in the study (52 weeks)

Secondary Outcomes

Assessing medication persistence

Medication persistence is defined as the duration of time from initiation to discontinuation of therapy.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 48 weeks of treatment period