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
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
1 other identifier
observational
139
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2016
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedStudy Start
First participant enrolled
December 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2019
CompletedOctober 8, 2020
October 1, 2020
2.8 years
November 28, 2016
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Up to 30 days after administering last dose in the study (52 weeks)
Number 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 rheumatoid arthritis (RA) and SpA.
Up to 30 days after administering last dose in the study (52 weeks)
Secondary Outcomes (4)
Assessing medication persistence
Up to 48 weeks of treatment period
Assessing medication adherence
Up to 48 weeks of treatment period
Change of disease activity in participants with PsA
Up to 48 weeks of treatment period
Change of disease activity in participants with AS
Up to 48 weeks of treatment period
Study Arms (1)
Participants with Spondylarthritis
Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation.
Eligibility Criteria
Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) participants treated with adalimumab in routine clinical settings in the Russian Federation.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (14)
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025
Kemerovo, Kemerovo Oblast, 650066, Russia
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379
Moscow, Moscow, 119049, Russia
Ivanovo Regional Clinical Hosp /ID# 167028
Ivanovo, 153040, Russia
Institution KhMAO-Ugra /ID# 154381
Khanty-Mansiysk, 628011, Russia
State Clinical policlinic /ID# 154374
Moscow, 107023, Russia
Central Research Institute /ID# 154375
Moscow, 111123, Russia
Research Institute of Rheum /ID# 154378
Moscow, 115522, Russia
Advisory-diagnostic Hospital /ID# 154382
Moscow, 117041, Russia
State Clinical Hospital /ID# 154373
Moscow, 119049, Russia
GBUZ Republican Hospital /ID# 167029
Petrozavodsk, 185019, Russia
Nort-Western State Medical Uni /ID# 154376
Saint Petersburg, 191015, Russia
Smolensk station JSC Russian R /ID# 167027
Smolensk, 214025, Russia
Tula Regional Clinical Hospita /ID# 155539
Tula, 300053, Russia
Yaroslavi State Medical Univer /ID# 154383
Yaroslavl, 150000, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2016
First Posted
December 9, 2016
Study Start
December 22, 2016
Primary Completion
October 16, 2019
Study Completion
October 16, 2019
Last Updated
October 8, 2020
Record last verified: 2020-10