A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

Hoffmann-La Roche200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Rheumatoid Arthritis

Interventions

TNF inhibitor/TCZDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (11)

Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen

Arvika, Sweden

Mälarsjukhuset; Reumatologkliniken

Eskilstuna, Sweden

Karolinska University Hospital, Huddinge; Rheumatology

Huddinge, Sweden

Blekingesjukhuset Karlskrona; Medicin, Rheumatology

Karlskrona, Sweden

Skånes Universitetssjukhus Malmö; Reumatologkliniken

Malmö, Sweden

Capio Citykliniken, Reumatologen

Malmö, Sweden

Örebro Uni Hospital; Rheumatology

Örebro, Sweden

Kaernsjukhuset; Dept of Medicine

Skövde, Sweden

Danderyds Sjukhus Ab; Rheumatology

Stockholm, Sweden

Lasarettet Trelleborg;Reumatologmottagningen

Trelleborg, Sweden

...and 1 more locations

Outcomes

Primary Outcomes

Percentage of participants with a decrease in dose of oral corticosteroids during the study

Time frame: From baseline to 6 months

Secondary Outcomes

Percentage of participants achieving C59CDAI remission (</=2.8)

Time frame: From baseline to 6 months

Percentage of participants achieving CDAI LDA (</=10)

Time frame: 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

Time frame: Baseline, Month 6

Percentage of participants for whom non-biologic DMARDs was added during observation period

Time frame: From baseline to 6 months

Percentage of participants with dose change in biological treatment during study

Time frame: From baseline to 6 months

Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study

Time frame: From baseline to 6 months

Percentage of participants who started or stopped oral corticosteroid treatment during the study period

Time frame: From baseline to 6 months

Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study

Time frame: 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

Time frame: From baseline to 6 months

Cumulated doses of oral corticosteroids during study period

Time frame: From baseline to 6 months

Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections

Time frame: From baseline to 6 months

Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections

Time frame: From baseline to 6 months

Cumulated doses of all corticosteroids during study period

Time frame: From baseline to 6 months

Mean dose of corticosteroids at start and end of study

Time frame: From baseline to 6 months

Mean change from baseline to end of study of corticosteroids

Time frame: Baseline, Month 6

Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score

Time frame: Baseline, Month 6

Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score

Time frame: Baseline, Month 6

Mean change from baseline to end of study in crohns disease activity index (CDAI) score

Time frame: Baseline, Month 6

Mean change from baseline to end of study in swollen 28 joint count

Time frame: Baseline, Month 6

Mean change from baseline to end of study in tender 28 joint count

Time frame: Baseline, Month 6

Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale)

Time frame: Baseline, Month 6

Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale)

Time frame: Baseline, Month 6

Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI)

Time frame: Baseline, Month 6

Mean change from baseline to end of study in Severity of pain (VAS scale)

Time frame: Baseline, Month 6

Mean change from baseline to end of study in EULAR response

Time frame: Baseline, Month 6

Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6)

Time frame: From baseline to 6 months

Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2)

Time frame: From baseline to 6 months