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NCT Number: NCT02988674

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

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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Key information

Conditions

Spondylarthritis Ankylosing Spondylitis (AS) Ankylosis Arthritis Arthritis, Psoriatic Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of participants on adalimumab therapy

    Time frame: 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.

  2. Number of participants on adalimumab therapy

    Time frame: 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 outcomes

  1. Assessing medication persistence

    Time frame: Up to 48 weeks of treatment period

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

  2. Assessing medication adherence

    Time frame: 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.

  3. Change of disease activity in participants with PsA

    Time frame: Up to 48 weeks of treatment period

    This is assessed using Disease activity score 28 joints count (DAS28) in participants with PsA.

  4. Change of disease activity in participants with AS

    Time frame: Up to 48 weeks of treatment period

    This is assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with AS.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: Adherence

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 9, 2016
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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