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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-22

Study Completion Date

2019-10-16

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.

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Detailed Description

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Conditions

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Spondylarthritis Psoriatic Arthritis Ankylosing Spondylitis (AS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Spondylarthritis

Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation.

No interventions assigned to this group

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No