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

AbbVie

Status: Completed

Conditions: Ankylosing Spondylitis (AS); Psoriatic Arthritis; Spondylarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02988674

P15-672

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

139 participants in 1 patient group

Participants with Spondylarthritis

Description:

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