Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DRUGTNF inhibitor/TCZ
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age. * With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria. * Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors). * The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment. * Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.
Exclusion criteria
* Have had more than one TNF-inhibitor prior to the enrolment visit. * Have had biological treatment other than TNF-inhibitors. * Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with a decrease in dose of oral corticosteroids during the study | From baseline to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving C59CDAI remission (</=2.8) | From baseline to 6 months |
| 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 |
| Percentage of participants achieving CDAI LDA (</=10) | From baseline to 6 months |
| 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 |
| Mean change from baseline to end of study of corticosteroids | Baseline, Month 6 |
Countries
Sweden
Outcome results
None listed