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 (Adherence)

October 6, 2020 updated by: AbbVie

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Ivanovo, Russian Federation, 153040
        • Ivanovo Regional Clinical Hosp /ID# 167028
      • Khanty-mansiysk, Russian Federation, 628011
        • Institution KhMAO-Ugra /ID# 154381
      • Moscow, Russian Federation, 107023
        • State Clinical policlinic /ID# 154374
      • Moscow, Russian Federation, 111123
        • Central Research Institute /ID# 154375
      • Moscow, Russian Federation, 115522
        • Research Institute of Rheum /ID# 154378
      • Moscow, Russian Federation, 117041
        • Advisory-diagnostic Hospital /ID# 154382
      • Moscow, Russian Federation, 119049
        • State Clinical Hospital /ID# 154373
      • Petrozavodsk, Russian Federation, 185019
        • GBUZ Republican Hospital /ID# 167029
      • Smolensk, Russian Federation, 214025
        • Smolensk station JSC Russian R /ID# 167027
      • St. Petersburg, Russian Federation, 191015
        • Nort-Western State Medical Uni /ID# 154376
      • Tula, Russian Federation, 300053
        • Tula Regional Clinical Hospita /ID# 155539
      • Yaroslavl, Russian Federation, 150000
        • Yaroslavi State Medical Univer /ID# 154383
    • Kemerovskaya Oblast
      • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650066
        • Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025
    • Moskva
      • Moscow, Moskva, Russian Federation, 119049
        • Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
Time Frame: Up to 48 weeks of treatment period
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
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.
Up to 48 weeks of treatment period
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.
Up to 48 weeks of treatment period
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.
Up to 48 weeks of treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2016

Primary Completion (Actual)

October 16, 2019

Study Completion (Actual)

October 16, 2019

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-672

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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