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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Spondylarthritis | Participants with Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) treated with adalimumab in routine clinical settings in the Russian Federation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Assessing medication adherence |
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Inclusion Criteria:
Exclusion Criteria:
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Spondylarthritis (ankylosing spondylitis and psoriatic arthritis) participants treated with adalimumab in routine clinical settings in the Russian Federation.
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 167025 | Kemerovo | Kemerovo Oblast | 650066 | Russia | ||
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D025242 | Spondylarthropathies |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
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