Ankylosing Spondylitis (AS), Psoriatic Arthritis, Spondylarthritis
Conditions
Keywords
Adalimumab, Ankylosing spondylitis, Psoriatic arthritis, Spondylarthritis, Humira®
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants on adalimumab therapy | 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. |
| Number of participants on adalimumab therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing medication persistence | Up to 48 weeks of treatment period | Medication persistence is defined as the duration of time from initiation to discontinuation of therapy. |
| Assessing medication adherence | 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. |
| Change of disease activity in participants with PsA | Up to 48 weeks of treatment period | This is assessed using Disease activity score 28 joints count (DAS28) in participants with PsA. |
| Change of disease activity in participants with AS | Up to 48 weeks of treatment period | This is assessed using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in participants with AS. |
Countries
Russia
Outcome results
None listed