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This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA participants treated with a TNF inhibitor or TCZ | Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNF inhibitor/TCZ | Drug | Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a decrease in dose of oral corticosteroids during the study | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving C59CDAI remission (</=2.8) | From baseline to 6 months | |
| Percentage of participants achieving CDAI LDA (</=10) | From baseline to 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria or 2010 ACR/EULAR RA classification criteria who have had an insufficient response or intolerance to their first TNF-inhibitor.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen | Arvika | 671 80 | Sweden | |||
| Mälarsjukhuset; Reumatologkliniken |
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|
| Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period |
| Baseline, Month 6 |
| Percentage of participants for whom non-biologic DMARDs was added during observation period | From baseline to 6 months |
| Percentage of participants with dose change in biological treatment during study | From baseline to 6 months |
| Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study | From baseline to 6 months |
| Percentage of participants who started or stopped oral corticosteroid treatment during the study period | From baseline to 6 months |
| Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study | From baseline to 6 months |
| Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline | From baseline to 6 months |
| Cumulated doses of oral corticosteroids during study period | From baseline to 6 months |
| Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections | From baseline to 6 months |
| Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections | From baseline to 6 months |
| Cumulated doses of all corticosteroids during study period | From baseline to 6 months |
| Mean dose of corticosteroids at start and end of study | From baseline to 6 months |
| Mean change from baseline to end of study of corticosteroids | Baseline, Month 6 |
| Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score | Baseline, Month 6 |
| Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score | Baseline, Month 6 |
| Mean change from baseline to end of study in crohns disease activity index (CDAI) score | Baseline, Month 6 |
| Mean change from baseline to end of study in swollen 28 joint count | Baseline, Month 6 |
| Mean change from baseline to end of study in tender 28 joint count | Baseline, Month 6 |
| Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale) | Baseline, Month 6 |
| Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale) | Baseline, Month 6 |
| Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, Month 6 |
| Mean change from baseline to end of study in Severity of pain (VAS scale) | Baseline, Month 6 |
| Mean change from baseline to end of study in EULAR response | Baseline, Month 6 |
| Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6) | From baseline to 6 months |
| Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2) | From baseline to 6 months |
| Eskilstuna |
| 631 88 |
| Sweden |
| Karolinska University Hospital, Huddinge; Rheumatology | Huddinge | SE-141 86 | Sweden |
| Blekingesjukhuset Karlskrona; Medicin, Rheumatology | Karlskrona | 37185 | Sweden |
| Skånes Universitetssjukhus Malmö; Reumatologkliniken | Malmö | 205 02 | Sweden |
| Capio Citykliniken, Reumatologen | Malmö | 212 28 | Sweden |
| Örebro Uni Hospital; Rheumatology | Örebro | 70185 | Sweden |
| Kaernsjukhuset; Dept of Medicine | Skövde | 54185 | Sweden |
| Danderyds Sjukhus Ab; Rheumatology | Stockholm | 18288 | Sweden |
| Lasarettet Trelleborg;Reumatologmottagningen | Trelleborg | 231 85 | Sweden |
| Akademiska sjukhuset, Reumatologkliniken | Uppsala | 75185 | Sweden |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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