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.
- Registration Number
- NCT02679001
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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.
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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).
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RA participants treated with a TNF inhibitor or TCZ TNF inhibitor/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.
- Primary Outcome Measures
Name Time Method Percentage of participants with a decrease in dose of oral corticosteroids during the study From baseline to 6 months
- Secondary Outcome Measures
Name Time Method 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 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 with dose change in biological treatment during 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 Mean change from baseline to end of study in EULAR response Baseline, Month 6 Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study 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 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 Patient Global Assessment of disease activity (VAS scale) Baseline, Month 6 Mean change from baseline to end of study in Severity of pain (VAS scale) Baseline, Month 6 Percentage of participants for whom non-biologic DMARDs was added during observation period 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 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 Health Assessment Questionnaire Disability Index (HAQ-DI) Baseline, Month 6 Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6) 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 Mean dose of corticosteroids at start and end of study From baseline to 6 months 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 tender 28 joint count Baseline, Month 6 Percentage of participants who started or stopped oral corticosteroid treatment during the study period 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 Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale) Baseline, Month 6 Cumulated doses of all corticosteroids during study period From baseline to 6 months Mean change from baseline to end of study in crohns disease activity index (CDAI) score Baseline, Month 6 Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2) From baseline to 6 months
Trial Locations
- Locations (11)
Örebro Uni Hospital; Rheumatology
🇸🇪Oerebro, Sweden
Mälarsjukhuset; Reumatologkliniken
🇸🇪Eskilstuna, Sweden
Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen
🇸🇪Arvika, Sweden
Karolinska University Hospital, Huddinge; Rheumatology
🇸🇪Huddinge, Sweden
Skånes Universitetssjukhus Malmö; Reumatologkliniken
🇸🇪Malmo, Sweden
Capio Citykliniken, Reumatologen
🇸🇪Malmö, Sweden
Blekingesjukhuset Karlskrona; Medicin, Rheumatology
🇸🇪Karlskrona, Sweden
Kaernsjukhuset; Dept of Medicine
🇸🇪Skoevde, Sweden
Danderyds Sjukhus Ab; Rheumatology
🇸🇪Stockholm, Sweden
Lasarettet Trelleborg;Reumatologmottagningen
🇸🇪Trelleborg, Sweden
Akademiska sjukhuset, Reumatologkliniken
🇸🇪Uppsala, Sweden