Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylarthritis
Psoriatic Arthritis
Ankylosing Spondylitis (AS)
Keywords: Adalimumab
Ankylosing spondylitis
Psoriatic arthritis
Spondylarthritis
Humira®
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-12-09
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants on adalimumab therapy
timeFrame: Up to 30 days after administering last dose in the study (52 weeks)
measure: Number of participants on adalimumab therapy
timeFrame: Up to 30 days after administering last dose in the study (52 weeks)
Secondary outcomes:
measure: Assessing medication persistence
timeFrame: Up to 48 weeks of treatment period
measure: Assessing medication adherence
timeFrame: Up to 48 weeks of treatment period
measure: Change of disease activity in participants with PsA
timeFrame: Up to 48 weeks of treatment period
measure: Change of disease activity in participants with AS
timeFrame: Up to 48 weeks of treatment period
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025
state: Kemerovskaya Oblast
city: Moscow
country: Russian Federation
facility: Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 154379
state: Moskva
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Clinical Hosp /ID# 167028
city: Khanty-mansiysk
country: Russian Federation
facility: Institution KhMAO-Ugra /ID# 154381
city: Moscow
country: Russian Federation
facility: State Clinical policlinic /ID# 154374
city: Moscow
country: Russian Federation
facility: Central Research Institute /ID# 154375
city: Moscow
country: Russian Federation
facility: Research Institute of Rheum /ID# 154378
city: Moscow
country: Russian Federation
facility: Advisory-diagnostic Hospital /ID# 154382
city: Moscow
country: Russian Federation
facility: State Clinical Hospital /ID# 154373
city: Petrozavodsk
country: Russian Federation
facility: GBUZ Republican Hospital /ID# 167029
city: Smolensk
country: Russian Federation
facility: Smolensk station JSC Russian R /ID# 167027
city: St. Petersburg
country: Russian Federation
facility: Nort-Western State Medical Uni /ID# 154376
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospita /ID# 155539
city: Yaroslavl
country: Russian Federation
facility: Yaroslavi State Medical Univer /ID# 154383
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: