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

Psoriatic Arthritis Clinical Trial

— Adherence  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988674
• Other study ID #: P15-672
• Status: Completed
• Start date: December 22, 2016
• Est. completion date: October 16, 2019

Study information

• Verified date: October 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Assessing medication persistence	Medication persistence is defined as the duration of time from initiation to discontinuation of therapy.	Up to 48 weeks of treatment period
Secondary	Assessing medication adherence	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
Secondary	Change of disease activity in participants with PsA	This is assessed using Disease activity score 28 joints count (DAS28) in participants with PsA.	Up to 48 weeks of treatment period
Secondary	Change of disease activity in participants with AS	This is assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with AS.	Up to 48 weeks of treatment period

External Links

•   clinical study report synopsis